Comparing the effects of
patient-tailored treatment to general exercise
and education in (sub)acute
non-specific neck pain patients.
A STUDY PROTOCOL
Laura Jansseune (01502541)
Cato Juwet (01402667)
Sofie Op de Beeck (01402702)
Supervisors: Dr. Vincent Dewitte, Marjolein Chys
A dissertation submitted to Ghent University in partial fulfilment of the requirements for the
degree of Master in Rehabilitation Sciences and Physiotherapy
Comparing the effects of
patient-tailored treatment to general exercise
and education in (sub)acute
non-specific neck pain patients.
A STUDY PROTOCOL
Laura Jansseune (01502541)
Cato Juwet (01402667)
Sofie Op de Beeck (01402702)
Supervisors: Dr. Vincent Dewitte, Marjolein Chys
A dissertation submitted to Ghent University in partial fulfilment of the requirements
for the degree of Master in Rehabilitation Sciences and Physiotherapy
Acknowledgments
First off, we would like to thank our parents for their support and encouragement. Furthermore, we would like to thank our supervisors Prof. Dr. Barbara Cagnie, Dr. Vincent Dewitte and Marjolein Chys for their constructive feedback and for guiding us through the many changes that led to the final form of this thesis. Next, we would like to thank the patients, who have already completed the program, and the general practitioners, who referred their patients to this study. The group, who composed the education program part of the intervention, Hélène, Ellen and Nanou, also deserves a thank you. We would also like to thank Maren, for rereading this thesis and helping us with the English language.
Index
List of tables and figures ... 4
List of tables ... 4 List of figures ... 4 List of abbreviations ... 5 Preamble ... 6 Abstract ... 7 English ... 7 Nederlands ... 8 Introduction ... 9 Methods ... 12 Study design ... 12
Study population and selection procedure ... 12
Eligibility criteria ... 12 Recruitment process ... 13 Randomization of patients ... 13 Sample size ... 14 Rehabilitation programs ... 14 Baseline assessment ... 17 Follow-up ... 18 Statistical analysis ... 18 Discussion ... 19 Strengths ... 19 Limitations ... 19 Conclusion ... 21 References ... 22 Abstract in lekentaal ... 25
Evidence ethical committee ... 26
Signed documents informed consent ... 32
List of tables and figures
List of tables
Table 1: Eligibility criteria Table 2: Treatment groups
Table 3: Timing of measurements
List of figures
Figure 1: Flowchart recruitment process Figure 2: Charts patient 1
Figure 3: Charts patient 2 Figure 4: Charts patient 1 and 2
List of abbreviations
RCT = Randomized Controlled Trial NSNP = Non-specific neck pain WAD = Whiplash Associated Disorder PTT = Patient-tailored therapyNPTT = Non-patient-tailored therapy NDI = Neck Disability Index
NRS = Numerique Rating Scale
GPES = Global Perceived Effect Scale
iMTA = Institute for Medical Technology Assessment iPCQ = Productivity Cost Questionnaire
iMCQ = Medical Consumption Questionnaire LBP = Low back pain
e.g. = Exempli gratia Etc. = Et cetera
CE = Cost-effectiveness
NSLBP = Non-specific low back pain BMI = Body mass index
SMC = Sensorimotoric control CCF = Craniocervical flexion T0 = Baseline testing
Tx = Testing at specific time
SPSS = Statistical Package for the Social Sciences e.d. = En dergelijke
6
Preamble
The following protocol is a description of a randomized controlled trial made to analyze the effect of patient-tailored therapy and non-patient-tailored therapy in patients with (sub)acute non-specific neck pain. The purpose of this study is to give the physiotherapists more clarity about the treatment methods in this particular population.
Patient-tailored therapy is therapy based on the individual clinical presentation of each patient. In this study this is done by first subjecting the patients of the patient-tailored group to a clinical examination based on the clinical reasoning model of O’ Sullivan.1 Subsequently, the patients
will receive an individual treatment program based on their main dysfunctions. Non-patient-tailored therapy, on the other hand, is a general program made by L.J., C.J. and S.ODB, who are 3 final year physiotherapy students from the University of Ghent. This general program can be found in the appendix 1. The third group in this study is a control group, who did not receive any type of intervention.
Two primary factors (neck pain and neck disability) and 3 secondary factors (global perceived effect, productivity costs and medical consumption) will be analyzed in this study.
The impetus for this study was already made last year in a literature study where the effect of active intervention in the secondary prevention of different subgroups of neck pain was examined.2 This literature study was made by the same students who were mentioned earlier.2
The current study is still in a start-up phase and thus not many people have been included in this study yet. Therefore, it is not possible to perform any data analysis at this moment. We did, however, describe 2 case reports, which can be found in appendix 2.
Also because of the COVID-19 virus (Corona), it was no longer possible to continue the treatments of the patients in this study.
7
Abstract
English
Study design
Study protocol for a randomized controlled trial (RCT).
Background
Non-specific neck pain (NSNP) is a common and disabling issue with a serious long-term socioeconomic impact. The clinical presentation of NSNP patients is very heterogeneous. The effect of active interventions has already been investigated in different kinds of neck pain patients. In patients with (sub)acute whiplash associated disorders (WAD), active therapy seems useful, while the effect of active therapy in patients with NSNP is still uncertain. Therefore, a patient-tailored approach may be beneficial.
Objective
This study will provide additional clarification to the physiotherapists about the effect of patient-tailored therapy (PTT) versus non-patient-patient-tailored therapy (NPTT) in patients with (sub)acute NSNP.
Methods/Design
An RCT will be conducted during 30 months for which the aim is to treat at least 123 patients with (sub)acute NSNP.
In- and exclusion criteria will be checked through an online survey. After inclusion, the participants will be randomly assigned to one of the 3 treatment groups (patient-tailored intervention, non-patient-tailored intervention or control group). The non-patient-tailored exercise program can be found in appendix 1.
The included patients will fill in an online questionnaire from week 1 to 9 and at 3, 6 and 12 months. The primary outcomes are disability (measured by the Neck Disability Index (NDI)) and pain (measured by the Numerique Rating Scale (NRS)). The secondary outcomes are global perceived effect using the Global Perceived Effect Scale (GPES) and treatment adherence, recurrence, work absenteeism and medication use, using the iMTA Productivity Costs Questionnaire (iPCQ) and the iMTA medical consumption questionnaire (iMCQ).
Discussion
The hypothesis of this study is that PTT is superior to NPTT in (sub)acute NSNP patients. In low back pain (LBP) patients there is already evidence that, in a clinical setting, a tailored approach can contribute to more therapy adherence, a higher level of patient satisfaction and a prevention of complaints becoming chronic. Hopefully, this research will provide more clarification about the advantages of a tailored approach in (sub)acute NSNP patients.
Furthermore, 2 case reports were composed (see appendix 2).
Trial registration
Clinicaltrials.gov: Protocol ID (trial registration) = ID: B670201941044 Identifier = NCT04182035
Keywords
8
Nederlands
Onderzoeksdesign
Studieprotocol voor een gerandomiseerd onderzoek met controlegroep.
Achtergrond
Niet-specifieke nekpijn is een vaak voorkomend probleem met, op lange termijn, een grote socio-economische impact. De klinische presentatie van deze nekpijngroep is zeer heterogeen, wat suggereert dat een aanpak gebaseerd op de klinische presentatie van de patiënt gunstig kan zijn.
Doelstelling:
Deze studie zal de kinesitherapeuten aanvullende verduidelijking geven over het effect van op maat gemaakte therapie (op basis van de klinische presentatie van de patiënt) ten opzichte van een standaard behandelprogramma in een patiëntenpopulatie met (sub)acute niet-specifieke nekpijn.
Methode
Een RCT-studie waarbij het de bedoeling is om gedurende 30 maanden zeker 123 patiënten met (sub)acute niet-specifieke nekpijn te behandelen.
De deelnemers worden via een online vragenlijst gerekruteerd. Na inclusie zullen ze willekeurig één van de 3 behandelgroepen toegekend krijgen (therapie op basis van de klinische presentatie, niet op maat gemaakte therapie (standaardprogramma) of controlegroep). Het oefenprogramma van de standaardtherapie is terug te vinden in bijlage 1. De deelnemers aan de studie zullen iedere week een online vragenlijst moeten invullen gedurende de 9 weken van het programma en na 3, 6 en 12 maand.
De primaire metingen zijn de NDI- en NRS-scores. De secondaire metingen bevat de GPES en de iMTA vragenlijsten, waaronder de iPCQ en de iMCQ vragenlijsten.
Discussie
De hypothese van deze studie luidt als volgt: een individueel gematchte therapie is superieur aan een algemeen behandelprogramma in (sub)acute niet-specifieke nekpijnpatiënten. In de literatuur omtrent lage rugpijn patiënten is er reeds evidentie dat een op maat gemaakte therapie positief kan bijdragen tot de klinische praktijk, onder andere wat betreft therapietrouw, tevredenheid van de patiënten en het voorkomen dat de klachten chronisch worden. Hopelijk zal dit onderzoek meer inzicht kunnen leveren in de voordelen van een op maat gemaakte therapie in (sub)acute niet-specifieke nekpijnpatiënten.
Ook werden er 2 casusrapporten uitgewerkt (zie bijlage 2).
Registratie van de trial
Clinicaltrials.gov: Protocol ID (trial registration) = ID: B670201941044 Identifier = NCT04182035
Sleutelwoorden
9
Introduction
Neck pain is defined as “an unpleasant sensory and emotional experience
associated with actual or potential tissue damage in the region of the neck” (IASP, 2017).3
The Neck Pain Task Force also adds radiation to the head, trunk and the upper limbs to this definition.4
This condition is complicated and has a heterogeneous presentation, which makes it tough to cure.5 It is a common disabling issue with up to 70% of the population experiencing an episode
of neck pain at least once in their lifetime.6 In 50% of neck pain cases, patients continue to
experience pain after 1 year.7,8
Even though several types of neck pain exist, this study will focus solely on non-specific neck pain (NSNP). This is a type of neck pain of which the origin is indistinct.9 Based on duration of
the symptoms, 3 stages can be distinguished: acute (< 6 weeks), subacute (6-12 weeks) and chronic (> 12 weeks) neck pain.10
Chronic neck pain has an enormous socioeconomic impact11 and the aftermath of chronic neck
pain ranges from a short time where only limited activity is possible to severe chronic hindrance on performance and work capability.12 This contributes to socioeconomic outcomes such as
more sick leave, premature retirement and/or incompetence pension.12 The socioeconomic
burden of chronic neck pain also results in financial strain (e.g. medical, pharmaceutical, absenteeism costs).13
Therefore, the assumption can be made that treatment of neck pain in its earlier phases is crucial to prevent chronic neck pain and its socioeconomic implications.
A possible solution to prevent neck pain from becoming chronic, can be patient-tailored intervention.14 Patient-tailored intervention, or in other words matched care, entails the
identification of patients with a bigger risk of becoming chronic.14
Furthermore, this type of intervention is conformed to the individual clinical presentation and to the individual risk factors that are present.14 So, this means that only when a risk factor
exists, a treatment will be developed based on that particular risk factor.14
This study will focus on the comparison between the influence of patient-tailored therapy (PTT) and that of non-patient-tailored therapy (NPTT) in a population with (sub)acute NSNP. Besides manual therapy and active intervention, education is a part of these therapies as well. It is known that education is an important part of the rehabilitation of neck pain.15 However, in order
to reduce neck pain, education on itself is less efficient than education combined with specific training.15 The article of Ris et al. (2016) also shows the benefit of education in combination
with specific exercises when it comes to health-related quality of life in neck pain patients.16
Although these 2 findings were in patients with chronic neck pain,15,16 the importance of
education has also been investigated in subacute NSNP patients, more specifically education on anatomy, pain, risk factors, healing, inaccurate concepts, posture, ergonomics, relaxation, coping and stress management, exercise and activities, medication, etc.17 This, in combination
with an exercise program and some relaxation techniques, forms a good rehabilitation program in the management of patients with subacute NSNP.17 Because of the above-mentioned
evidence found on education in the rehabilitation of neck pain, it seems important to integrate this in the study.
Another part of the given therapy is active intervention. While earlier research on this topic has concluded that active intervention has a positive influence on patients with (sub)acute whiplash associated disorders (WAD)18-20, there is still some incoherence in the results on the influence
of active interventions in patients with (sub)acute NSNP21,22 and in patients with (sub)acute
cervical radiculopathy.23,24
The slight uncertainty about the influence of active intervention in patients with NSNP may be due to the heterogeneity in this population. In the group of NSNP, a diversity of impairments
10
can be present, which makes it difficult to divide the NSNP patients in homogeneous subgroups.9 Subgrouping patients may lead to an increase in treatment efficiency.9Treatments tailored to the clinical presentation of the patient within these homogenous subgroups could maximize this treatment efficiency.
Some research has already been done in the past about patient-tailored intervention, but this was mostly inconclusive. For example, the review of Linton et al. (2018) assumes that patient-tailored intervention or matched cared would be more beneficial than a more general treatment that does not take into account the individual clinical presentation of the patient.14 It is advisable
to switch from a ‘wait-and-see’ attitude towards a patient-tailored approach, although there is still a lack of evidence of the efficacy, effectiveness and cost-effectiveness (CE) of this type of intervention.14 The problem with this review is that the separate studies conduct research on,
for example, matched care, even though they do not compare it with a non-tailored intervention in the same article.14 Furthermore, these findings concerned patients with acute LBP.14
Consequently, it is neither possible to draw a conclusion, nor to apply the given research on patients with (sub)acute neck pain.
There is also some existing literature about a patient-tailored approach in patients with neck pain. For example, Bunketorp et al. (2006) proved that a patient-tailored approach is more beneficial than home training.25 However, it should be noted that the tailored treatment was
less cost-effective than the home training intervention.25 Moreover, it should not be forgotten
that this study was about patients with subacute WAD.25 The same positive effect of neck
specific exercises can be seen in chronic WAD patients.26 Also in patients with cervical
radiculopathy neck-specific training and exercises (tailored to the patient) in combination with behavioral therapy, is beneficial in the long run.27
A study very similar to this protocol study is the one of Svedmark et al. (2016). This study did research on the effect of a patient-tailored intervention in comparison with a non-patient-tailored intervention in a population with NSNP, more specifically in women with NSNP.28 This
study confirmed that the neck complaints in both the PPT and NPTT group improved.28 The
same results did not occur when opted for the no treatment strategy.28 Unfortunately, this study
does not show any difference between the PTT and NPTT group.28
According to O’ Sullivan, the absence of (multiple) evidence for a PTT-approach is a consequence of the heterogeneity of the chronic non-specific low back pain (NSLBP) group on the one hand and the deficiency of a patient-centered biopsychosocial approach on the other.29 O’Sullivan proposed a potential mechanism-based classification system which may
cause a more efficient treatment program per individual.29 It is difficult to label this chronic
NSLBP group with a diagnosis, considering there are a lot of factors involved such as alterations in physical factors, neurophysiology, way of living, psychosocial aspects, changes in motor control, and in a smaller proportion, of patho-anatomical factors.29 It is not always
clear if these factors appear as a reason for or as a result of chronic NSLBP.29 Thus, the
concept of subgrouping can provide a more fitting management.29
Nowadays, the NSNP approach is to manage symptoms and functional impairments.28 The
most evidence-based treatment for non-specific neck-shoulder pain is a multimodal rehabilitation method, but it is not clear how to construct these therapy sessions in order to obtain the most positive outcome.30
In clinical settings, these patients are examined and offered a tailored treatment which encompasses an individual training in function of their needs.28 The act of subgrouping patients
with NSNP as well as an individual physiotherapeutic examination could lead to an enhanced payoff for rehabilitation.28 However, there is still too little evidence to suggest that said
patient-specific treatment is as efficiently as doable and also if this tailoring is favorable.28
The CE of the given treatments should also not be forgotten.
Because the PTT group can provide both manual and active therapy, it seemed useful to compare their CE. The CE of exercise therapy in patients with neck pain is still under
11
discussion. A systematic review of Driessen et al. (2012) demonstrated that manual therapy is superior to physiotherapy, while the same review also finds that the combination of advice, exercise and manual therapy is not more cost-effective in comparison with advice and exercise only.31 The latter was also confirmed in the study of Lewis et al. 2007.32 However, the study ofMiyamoto et al. (2018) found no difference in CE when comparing exercise therapy and manual therapy as a treatment for neck pain patients.33
Even though the comparison between manual therapy and exercises is vital information, the CE of patient-tailored therapy should also be taken into account in this study. However, the CE of patient-tailored exercises in patients with NSNP is still unclear due to the lack of available studies.
Taking all this into account, the main goal of the current study is to provide additional clarification to the physiotherapists about whether or not PTT intervention is superior to NPTT.
12
Methods
Study design
This is a study protocol for an RCT. Starting October 2019, patients will be recruited with (sub)acute NSNP. The aim is to treat 123 patients with NSNP in the course of 30 months. The patients will be randomly divided into one of the 3 treatment arms. The physiotherapists will not be aware of the randomization process, although they cannot be blinded to the type of intervention they will have to give because of the nature of this study. The individual treatment sessions with physiotherapists will take place at the campus of the University Hospital of Ghent.
This study has been approved on the 8th of October 2019 by the ethics committee of Ghent University Hospital Belgium.
Study population and selection procedure
The study population in this trial will consist of patients with (sub)acute NSNP, thus neck pain that has been around for less than 3 months. In table 1 the in- and exclusion criteria can be found.Many platforms will be used to recruit patients with NSNP such as: social media, email, flyers and general practitioners’ practices.
Eligibility criteria
Inclusion Exclusion
Age: 18-65 Neck pain > 3 months
Primary symptoms: neck pain Structural neck pathology Duration neck pain < 12 weeks or recurrent
neck pain with last episode > 3 months ago
Secondary neck pain
NDI ≥ 10% and ≤ 68% Recurrent neck pain + episode in last 3 months
NRS > 3/10 BMI > 30 kg/m²
Other cardiovascular, metabolic, systemic or neurological diseases History of surgery in neck, head or shoulders
Probable/definite neuropathic pain (classification of Finnerup et al.)34
Pregnancy/given birth in last year History of disabling chronic/recurrent LBP
Primary headache Hypermobile patients
13
Risk stratification: Startback tool for neck pain: high risk groupTable 1: Eligibility criteria
Recruitment process
Interested participants will be able to send an email which will be answered with an online questionnaire (Limesurvey). This will be the baseline assessment, which will be explained further on. This information will determine whether or not the person in question is included or excluded in this study. In case of doubt, a third researcher will be contacted.
An overview of the recruitment process can be found in figure 1.
Figure 1: flowchart recruitment process
Randomization of patients
Participants will be randomly assigned to one of the 3 groups and to either of the 2 therapists by an independent external person, who is blinded for the allocation. The allocation will have a 1:1:1-ratio, meaning each group will have the same number of patients. The randomization will be executed by a computer-generated number sequence using the website “Randomizer”.35 In blocks of 10 patients, each patient will be divided into one of the 3 groups.
The gender of the participants will be taken into account during the randomization. Subsequently, the allocated participants will be scheduled for their first assessment within 1 week of the randomization. The interventions will be performed by trained therapists.
Blinding/Masking:
The outcome assessors and the practitioners will be concealed from the randomization process. The outcome assessors will be blinded as much as possible.
The patients will not be conscious of the allocated treatment arm, but they will of course be aware of the intervention they will receive. To diminish the contamination among groups, the intervention will happen at different moments during the day. The patients will not see each other in the waiting rooms.
14
Sample size
To establish the sample size, power analysis will be performed using the G power 3.1.9.2 software. Obtaining a power of at least 80%, demands at least 102 participants. A 20% drop out rate will be taken into account, leading to the recruitment of at least 123 participants.
Measurements
Primary outcomes
The primary outcomes will be pain and disability, which will be evaluated by the (Neck Disability Index (NDI) and Numerique Rating Scale (NRS). The NDI is a questionnaire that evaluates the degree of disability.6 It questions 10 items: ‘pain intensity’, ‘personal care’, ‘lifting’, ‘sleep’,
‘driving’, ‘sex life’, ‘headaches’, ‘concentration’, ‘reading’ and ‘work’.36 Every item is appointed
a score out of 5, resulting in a total score of maximum 50.36 A higher total score will represent
a higher degree of disability,6 with a score of 0-4 meaning ‘no disability’, a score of 5-14 mild
disability, 15-24 moderate disability, 25-34 severe disability and over 34 complete disability.36
The NRS is a one-dimensional questionnaire for evaluating pain intensity over the course of the last 7 days and the last 24 hours.37 It is an 11 point-scale, 0 stands for “completely no pain”
and 10 for “the worst possible pain you can imagine”.37 The patients need to select a number
from 0 to 10 that reflects their pain intensity best.37
A cut-off score of 30% decrease in NDI/NRS will be regarded as clinically relevant.6,38
Secondary outcomes
The secondary outcome measurements used in this study will be global perceived effect using the Global Perceived Effect Scale (GPES) as well as treatment adherence, recurrence, work absenteeism and medication use for which the iMTA Productivity Costs Questionnaire (iPCQ) and iMTA medical consumption questionnaire (iMCQ) will be used.
GPES is a numeric scale (7-point scale) and it can be employed as a self-report tool.39 This
scale represents the patient’s perception of global worsening or improvement of the pain condition.39 The patients will be questioned about his/her extent of recovery and his/her
contentment with the received treatment using the 2-item version.
The iPCQ is a questionnaire that can be used to measure and assess the loss of productivity and can be applied in the economic assessment of health care.40 It subsists of 18 questions
all of which can be categorized in 3 modules: work presentism, absenteeism and productivity losses of unpaid work.40
The iMCQ consists of 31 questions concerning medication use and primary and secondary healthcare services.40 These scales will be used to assess health economic measures,
involving treatment faithfulness, medication use, evaluation of work absenteeism, appointments with primary and secondary care practitioners and productivity.40
Rehabilitation programs
The treatments will take place at the department of rehabilitation sciences at Ghent University. Each participant in the patient-tailored and in the non-patient-tailored group will receive a 9-week treatment program, with 9 treatment sessions under surveillance of a physiotherapist and 9 at home treatment sessions with a time span of 45 minutes each. This means that the participants will perform 2 therapy sessions per week, 1 with the therapist and 1 at home. The control group will not receive any intervention.
The 2 therapists who will perform the intervention are both competent in physiotherapy and manual therapy with each of them having gained a minimum of 3 year experience in daily clinical practice.
During the entire treatment period, the patients will be supervised by the same physiotherapist. The therapists who will be active in this study, will perform treatments in both the patient-tailored and the non-patient-patient-tailored group. They will also be specifically trained in divergent therapy modalities by experts in this field. Furthermore, the standardization and quality of the interventions will be monitored and the patient-therapist interactions will be limited to a minimum by switching roles between assessors and therapists over time. The supervision of
15
the 3 groups will be performed by a pre-doctoral researcher who works in a daily practice and has a master’s degree in physiotherapy and manual therapy.First group: Patient-tailored therapy
The subjects in this group will receive a tailored treatment program which will combine manual therapy and individualized exercises. Based on the clinical presentation of the patient, the intervention can consist of mobilizations, coordination and stabilization training, strength training, etc.
Furthermore, patient-tailored education and a selection of patient-tailored home exercises will be provided. The information about education will be given during the individual therapy session by the therapist. The home exercises will be adjusted every week depending on the evolution of the patient.
Before every treatment session, the NRS- and NDI-scores will be collected.
Second group: Non-patient-tailored therapy
The subjects in this group will receive an individual treatment which will include hands-off modalities such as an active neck exercise program, education and home exercises which will however not be tailored to the situation of the individual patient. The 9-week program can be divided into 2 main parts. In the first 3 weeks active mobilizations of the shoulders, the cervical and thoracal region will be given. Furthermore, the patient will also receive sensorimotor control (SMC) training consisting of chin tuck (week 1), craniocervical flexion (CCF) (week 2 and 3) and scapula setting (week 1-3). The SMC training in this period will focus on perception and precision. From week 4 to 9 the intervention will generally consist of progressive cervical and scapulothoracal strength training. Cervical strength training will mainly be CCF, global flexion and extension. The scapulothoracic strength training will emphasize the serratus anterior, the lower trapezius and the middle trapezius (week 4-9) and the rhomboideï and the rotator stabilizers (week 5-9). Again, more advanced SMC training will be given (CCF and scapula setting), however this time the focus will be on repetition and integration in daily life situations. Throughout the entire program the warming up will remain the same (active mobilizations of the shoulder, cervical and thoracic spine). After the intervention, all the patients will perform cooling down which will exist of stretching exercises. This treatment program can be found in appendix 1. Case reports of 2 patients who already completed this 9-week program can be found in appendix 2.
While the education will be provided during the individual therapy session by the therapist, it will not be adjusted to the individual situation of the subjects. The education will be standardized and will contain information about the program itself as well as anatomy of the neck, biomechanics, sources of pain, diagnosis, advice, risk factors, ergonomics, pain physiology, coping skills, relaxation, movement/activities and finally tips for prevention. If something is not clear, the patients will be able to ask questions. The home exercise program will also be fixed and thus not adjusted to the individual situation of the subject. At home the patients will perform the same exercises as they were taught in the individual therapy session by the therapist.
Third group: Control group
The subjects who will be placed in the control group will not receive any intervention. Only medication use will be allowed which will be tracked by a separate online questionnaire based on questions of the iMTAQ.
These subjects will be followed up by means of a questionnaire that they will receive every week. This questionnaire will consist of NDI, NRS, medication use and any received treatments.
Furthermore, they will be asked not to look for other treatment methods if possible. Should they choose to pursue other treatment methods, then they will be considered as lost to follow-up.
An overview of the different treatment groups can be found in table 2 and the timing of the different measurements can be found in table 3.
16
Treatment group
Description Time treatment session Amount of sessions Patient-tailored therapy
manual therapy + exercise + education + home exercise program based on clinical presentation of the patient
45 minutes 9 sessions with physiotherapist (one each week) + home exercises
Non-patient-tailored therapy
exercise + education + home exercise program not adjusted to the individual clinical presentation, more general
45 minutes 9 sessions with physiotherapist (one each week) + home exercises
Control group no intervention
only medication if needed
/ no therapy
sessions, only online
questionnaire
17
Table 3: Timing of measurements
Baseline assessment
The baseline assessment will be done by means of a questionnaire. This questionnaire provides information about administrative data of the patient (name, age, height, email, phone number, residence), the complaints (pain intensity, disability, localization, associated symptoms, headache, etc.), medication use, history of the patient, specialized medical investigations, miscellaneous (pregnancy, illness, etc.), startback screening, health care use and work-related questions. This will be applied to all 3 groups (PTT, NPTT, control).
However, the PTT group will not only receive this questionnaire, but will also undergo an examination during the first therapy session. This examination is based on the book “Musculoskeletal clinical translation framework – from knowing to doing” by Tim Mitchell, Darren Beales, Helen Slater & Peter O’Sullivan. In this book a model is described that takes the most important risk factors into account and in turn makes it possible to create a holistic image of the patient.29 With this model, it is possible to classify the patients in the PTT group
according to the most dominant pain mechanism.
Timing Measurements Location
Baseline (T0) Primary:
· NDI & NRS
Secondary:
· iPCQ and iMCQ (iMTA)
Online questionnaire
Online questionnaire
During treatment (Tx) Primary:
· NDI (before start treatment)
· NRS (before start treatment)
Secondary:
· GPES (after 3-6-9 treatments)
· evaluation of treatment
adherence: evaluation of home-exercises
Ghent University
Ghent University
Post treatment: 3 weeks post intervention (T1) Primary · NDI & NRS Secondary · GPES Online questionnaire Online questionnaire
After 3 months (T2) Primary
· NDI & NRS
Secondary · GPES
· iPCQ & iMCQ (iMTA)
Online questionnaire
Online questionnaire
After 6 months (T3) After 12 months (T4)
18
Follow-up
PTT and NPTT group:
The study participants in these 2 groups will be followed up for a period of 9 weeks by the physiotherapist and by an online questionnaire. Based on these completed questionnaires, it will be possible to quickly register any adverse effects. After the 9-week program, the study participants will be asked to complete the online questionnaire again on the third week post intervention and once more after 3, 6 and 12 months.
Those who will be lost to follow-up in these 2 groups will concern patients who do not fulfil the 9-week program and those who cease to fill out the online questionnaires. Furthermore, patients who look for other therapy treatments will also be considered as lost to follow-up.
Control group:
In the control group the follow-up will happen online. Every week, for a period of 9 weeks, the person concerned will receive a questionnaire. This questionnaire will also be sent after 3, 6 and 12 months.
If this person in particular does not fill out this questionnaire, he/she will receive a reminder in the next week to do so. The patient will be considered as lost to follow-up when he/she looks for other therapy treatments or when the patient ceases to fulfil the questionnaire.
Statistical analysis
For the statistical analysis of this RCT the SPSS version 26 will be used. The pre-defined hypotheses with its pre-specified between-group contrasts will be tested with linear mixed-effects models, a method of analysis that has advantages to handle individual variances and missing values. A model will be made to assess the treatment effects with 2 independent fixed factors: time (baseline, 9 weeks, 3, 6 and 12 months will be used as reference) and the 3 groups (PTT, NPTT, Control). Participants will be included in the analysis model as a random effect. Treatment effects will be defined as between group effects. A 30% improvement means a clinical effect was reached.38
With this statistical analysis method, it will be possible to compare the effects of the different interventions with each other and to analyze whether or not administering the PTT program generates a supplementary effect. The significance level will be set at 0,05.
19
Discussion
As previously said, the aim of this study is to check whether a positive influence of PTT versus NPTT in patients with (sub)acute neck pain can be found. We would need better outcomes for the PTT group compared to the NPTT group to confirm our hypothesis that PTT is superior to NPTT in the rehabilitation of NSNP patients. Better improvements in the NPTT group could be explained by a high prevalence of patients with thoracic spine and scapular dysfunctions, seeing the general exercise program focused mostly on these problems.
The difference between PTT and NPTT lies in the fact that patient-tailored, or matched care as Linton et al. (2018) calls it, is based on the individual presentation of the patient.14 This
entails giving treatment based on the present individual risk factors of this patient.14
In contrast, NPTT is, in this particular study, a standard program based on the main treatable aspects (e.g. proprioception, coordination, mobility and strength).
PTT seems to have some proven advantages in a clinical setting:this type of therapy appears to have positive effects on the adherence to therapy and on the satisfaction of therapy, because the patients know that the therapy is adapted to their needs.14 Furthermore, for
avoiding chronicity and to make the rehabilitation more efficient, an individually adapted intervention seems useful, seeing it is possible to identify the most important risk factors and dysfunctions early on.14 This article does, however, concern LBP.14 For the influence on NSNP
more research is needed.
The influence of PTT on recurrent neck pain could also be an interesting notion, but no available studies were found concerning this subject.
In addition to the advantages, there are also some disadvantages or issues with PTT.
One issue for example is that a patient-tailored approach needs knowledge, expertise and resources.14 Moreover, a classification or subgrouping of the patients seems desirable to
provide a more fitting management.29
Generally, NSNP is not caused by a serious disease or pathology.41 As with NSLBP, NSNP is
often multifactorial in origin.41 This is an important reason why a patho-anatomical based
classification is not the most effective treatment guide.41 It can be more effective to treat NSNP
patients if they are distributed into subgroups based on the results of subjective and clinical examination results.41
Therefore, we hope that this research will provide more clarification about the benefit of a tailored approach in patients with (sub)acute NSNP.
Strengths
In this trial, strengths include a blinded randomization, the long term follow up (1 year) and the use of standardized outcome measures (NRS, NDI, GPES, iMTA). Because the NDI and the NRS are completed every week, it is possible to track the progress in neck pain and in disability closely. This way any occurring problems can be addressed immediately and a rapid downturn in scores will not go unnoticed. If there is a reduction of 30% in the NDI- or NRS-scores, then there is a clinical difference.38
Limitations
A logical limitation of this kind of study is the lack of blinding. The physiotherapist is always aware whether the patient is included in the PPT or in the NPTT group, which can lead to a possible performance bias. The patients in the control group also know in which group they were randomized, seeing as they do not receive any treatment. This lack of treatment in the control group instantly forms another limitation of this study. It also increases the chance of drop out when these patients seek treatment elsewhere or fail to complete the questionnaires.
20
Lastly, this study does not take into account any adverse events resulting from the given therapy.21
Conclusion
This study protocol is a description of an RCT made to analyze the effect of PTT and NPTT. The purpose of this study is to give the physiotherapists more clarity about the effect of these kinds of treatment options in (sub)acute NSNP.
PTT is a type of therapy where the treatment is based on the individual clinical presentation of the patient. In comparison with PTT, NPTT is a more generic approach. All the patients in this group receive the same exercise program and education. The effect of these 2 therapies will be analyzed based on several factors, namely pain, disability, global perceived effect, productivity costs and medical consumption.
We hypothesize that the results will show a better outcome for the PTT group and that this approach is more efficient than an NPTT method for both patient and physiotherapist.
We have constructed a randomized, controlled, single-blinded clinical trial, with the objective to assist in the expansion of scientific knowledge on this subject and to commence new possibilities for research on NSNP as well as new potential treatment.
22
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25
Abstract in lekentaal
Nekpijn is een veelvoorkomende aandoening, maar niet iedereen ervaart het op dezelfde manier. Dit kan bij de ene zorgen voor milde klachten, terwijl de andere bijvoorbeeld ook last heeft tijdens het slapen, het uitvoeren van dagelijkse handelingen/taken, e.d...
Het doel van deze studie is om een efficiëntere behandelmethode te onderzoeken voor nekpijn. Dit is niet altijd evident om gericht te behandelen, aangezien nekpijn op diverse manieren tot uiting kan komen. Hieruit kunnen we afleiden dat indien we alle patiënten met nekpijn volgens hetzelfde programma zouden behandelen, we niet iedereen kunnen helpen om zijn klachten onder controle te krijgen of om ze volledig weg te werken.
Deze studie zal 3 behandelgroepen met elkaar vergelijken gedurende 30 maanden. Een eerste groep is de individueel gerichte therapie waarbij we inspelen op de specifieke klachten van de patiënt zelf. In de tweede groep krijgen alle patiënten hetzelfde algemene oefenprogramma met algemene informatie over nekpijn. Als laatste hebben we een controlegroep die geen therapie krijgt. Ze zullen opgevolgd worden via een online vragenlijst.
Op deze manier is het mogelijk om na te gaan of een individueel gerichte aanpak tot betere resultaten zou leiden bij de behandeling van nekpijn i.t.t. een meer algemene benadering.
26
Evidence ethical committee
32
Signed documents informed consent
35
Appendices
Week 1 Opwarming (5 min) Mobilisatie oefeningen1. Hoofd naar voor buigen 2. Halve cirkel voorwaarts
3. Oor naar schouder brengen: LF li-re 4. Draaien van het hoofd naar links-rechts 5. Schouder voorwaarts rollen
6. Schouder achterwaarts rollen
7. Schouders naar voor en achter brengen
Binnen de pijngrens 10 herhalingen per oefening Mobilisatie oefeningen voor de schouders en
thoracale wervelzuil: 1. Beweeg de schouders naar boven toe, met lichte spanning op de weerstandsband. Breng vervolgens de armen achter het hoofd zoals op de foto.
2. Sta in handen-knieënsteun, kijk met het gezicht naar de tafel en draai open met 1 arm zodat de hand boven de schouder komt; draai
vervolgens onder de romp door. Doe dit aan de 2 zijden
Binnen de pijngrens 30 herhalingen per oefening
36
Proprioceptieve oefeningen &
motorische controle oefeningen
- Chin tuck oefenen; beweeg het hoofd naar achter zodat de oren mooi boven de schouders komen staan, beeld je in dat er een ballonnetje aan je achterhoofd hangt
- Oefenen van de „ja-knik“-beweging: o Lig op de rug, zorg ervoor dat het
aangezicht horizontaal ligt (plaats eventueel een handdoekje onder het achterhoofd); probeer een kleine “ja-knik”-beweging te maken, zonder dat de grote nekspieren opspannen.
30 herhalingen
10*10sec
Stretching: - Trapezius:
• Houding: zit met de arm aan de te stretchen zijde op de rug (deze schouder gaat naar beneden)
• Handeling:
Stap 1: beweeg het oor eerst richting de tegenovergestelde schoudertop
Stap 2: draai hierna het hoofd naar de te stretchen zijde terwijl je stap 1 aanhoudt (draai je neus richting het plafond)
• Voorbeeld: linker trapezius stretchen • Linkerarm op de rug, linkerschouder
komt wat naar beneden
• Breng het rechteroor naar de rechter schoudertop
• Draai het hoofd naar de linkerzijde, draai de neus richting het plafond terwijl je de voorgaande beweging aanhoudt.
Volgens rekpijn, 5*20 sec, 3x/dag
37
- Levator• Houding: zit met de hand aan de te stretchen zijde in de nek
• Handeling:
• Stap 1: breng het hoofd lichtjes naar voor.
• Stap 2: beweeg het oor eerst richting de tegenovergestelde schoudertop
• Stap 2: draai hierna het hoofd naar de tegenovergestelde zijde (weg van de te stretchen zijde) terwijl je stap 1
aanhoudt, draai de neus naar de oksel. • Voorbeeld: linker levator scapulae stretchen:
• Linkerarm omhoog
• Beweeg het hoofd wat naar voor en leg het rechteroor naar de rechterschouder. • Draai de punt van de neus naar de
rechteroksel.
• Eventueel kan je met de rechterarm deze beweging begeleiden om iets meer stretch te krijgen.
- Pectoralis Maior
• Houding: Sta in de deuropening met de armen naast het lichaam, de ellebogen steunen tegen de deurlijst. Ellebogen op schouderhoogte of hoger.
• Handeling:
• Stap 1: Zet een stap naar voor en voel de rek aan de voorzijde van de borstkas en schouders
• Let op niet te veel door te hangen in de rug.
38
- Pectoralis minor• Houding: Lig op de rug, benen geplooid. • Handeling:
• Stap 1: probeer de lage rug tegen de ondergrond te houden
• Stap 2: haak de vingers in elkaar, maak een omgekeerd hoedje.
• Stap 3: breng de armen naar boven, zo hoog mogelijk en adem uit; probeer de rug tegen de ondergrond te houden.
Week 2 Opwarming (5 min)
Mobilisatie oefeningen
= idem week 1 + Geef lichte overdruk op het einde van de beweging indien mogelijk!
1. Hoofd naar voor buigen 2. Halve cirkel voorwaarts
3. Oor naar schouder brengen: LF li-re 4. Draaien van het hoofd naar links-rechts 5. Schouder voorwaarts rollen
6. Schouder achterwaarts rollen
7. Schouders naar voor en achter brengen
Binnen de pijngrens 10 herhalingen per oefening Mobilisatie oefeningen voor de schouders en
thoracale wervelzuil: 1. Beweeg de schouders naar boven toe, met lichte spanning op de weerstandsband. Breng vervolgens de armen achter het hoofd zoals op de foto.
Binnen de pijngrens 30 herhalingen per oefening
39
2. Sta in handen-knieënsteun, kijk met het gezichtnaar de tafel en draai open met 1 arm zodat de hand boven de schouder komt; draai
vervolgens onder de romp door. Doe dit aan de 2 zijden
Proprioceptieve oefeningen &
motorische controle oefeningen
- Chin tuck oefenen; idem w1
- Oefenen van de „ja-knik“-beweging: idem w1
- Correcte schouderbladpositie oefenen: o Starthouding: in buiklig & in zit o Handeling:
• Probeer een correcte scapula-positie aan te nemen door de
schouderbladen een klein beetje naar achter en naar beneden te trekken. Hierbij mogen de grote schouderspieren niet opspannen o Facilitatie methodes:
• Via het onderste puntje van je schouderblad. Hier dan voelen hoe dat de punt naar beneden beweegt bij een juiste positie.
• Het is alsof je de onderste punt van je schouderblad in je
30 herhalingen
10 x 10 sec.
10 x 10 sec per positie
40
tegenovergestelde broekzak wilsteken.
Stretching: - Nekspieren: Trapezius, levator: idem w 1
- Borstspieren: Pectoralis Maior & minor (omgekeerd hoedje)
NIEUWE OEFENINGEN
- Sternocleidomastoideus & scaleni o Houding: zit met de arm aan de
tegenovergestelde zijde op het hoofd en arm aan de te stretchen zijde op de rug o Handeling:
▪ Stap 1: trek je hoofd met de hand die op het hoofd ligt naar de schoudertop, adem diep uit – houd dit 20 sec aan
▪ Stap 2: draai hierna je hoofd naar de te stretchen zijde – adem diep uit
Volgens rekpijn, 5*20 sec, 3x/dag
41
▪ Hou dit 20 seconden aan en doedit 5 keer, 3x/dag o Voorbeeld: rechter
Sternocleidomastoideus & scaleni ▪ Rechterarm op de rug en
linkerarm op het hoofd – houd aan & adem diep uit
▪ Trek je hoofd naar de
linkerschoudertop en draai je hoofd naar de rechterzijde – houd aan & adem diep uit - Rhomboideï
o Starthouding: zit, armen voor je houden met ellebogen gebogen. Kruis de armen en haak de handen in elkaar
o Handeling:
▪ Duw je schouders naar voor
Week 3 Opwarming (5 min)
Mobilisatie oefeningen
= idem week 2 + Geef lichte overdruk op het einde van de beweging indien mogelijk!
1. Hoofd naar voor buigen 2. Halve cirkel voorwaarts
3. Oor naar schouder brengen: LF li-re 4. Draaien van het hoofd naar links-rechts 5. Schouder voorwaarts rollen
6. Schouder achterwaarts rollen
7. Schouders naar voor en achter brengen
Binnen de pijngrens 10 herhalingen per oefening Mobilisatie oefeningen voor de schouders en thoracale wervelzuil:
= Idem week 2 Binnen de
42
1. Beweeg de schouders naar boven toe, metmatige spanning op de weerstandsband. Breng vervolgens de armen achter het hoofd zoals op de foto.
! Hou de weerstand aan tijdens het oefenen!
2. Sta in handen-knieënsteun, kijk met het gezicht naar de tafel en draai open met 1 arm zodat de hand boven de schouder komt; draai
vervolgens onder de romp door. Doe dit aan de 2 zijden
! Doe dit met een gewichtje van +/- 1 kg in de hand!
3. Boogschutter
Neem de weerstandsband in beide handen vast. Doe afwisselend links-rechts een
boogschuttersbeweging: duw de voorste hand uit en trek de elleboog van de achterste arm naar boven tegen een lichte weerstand.
30 herhalingen 30 herhalingen per zijde 30 herhalingen per zijde Proprioceptieve oefeningen & motorische controle oefeningen
- Chin tuck oefenen; idem w1
- Oefenen van de „ja-knik“-beweging: idem w1
30 herhalingen
43
- Correcte schouderbladpositie oefenen:o Starthouding: in buiklig & in zit o Handeling:
• Probeer een correcte scapula-positie aan te nemen door de
schouderbladen een klein beetje naar achter en naar beneden te trekken. Hierbij mogen de grote schouderspieren niet opspannen - Oefening 1:
o Plaats 1 hand tegen de deurlijst; daartussen een licht
rollend voorwerp (balletje/flesje water) o De armpositie is licht voorwaarts en wat
naast het lichaam,
de elleboog lager dan de schouder. o Neem de correcte schouderpositie aan o Rol het balletje heel kort op & neer
terwijl je het
schouderblad in de juiste positie houdt.
- Oefening 2:
o Neem dezelfde positie aan als hierboven beschreven maar niet steunend tegen de deurlijst.
o De armpositie is licht voorwaarts en wat naast het lichaam, de elleboog lager dan de schouder.
o Neem de correcte schouderpositie aan o Schud een klein gewichtje (flesje water,
halfgevuld) op & neer terwijl je het schouderblad in de juiste positie houdt.
10 x 10 sec. per positie
44
Stretching: - Nekspieren: Trapezius, levator: idem w 1; - Voorste nekspieren (sternocleidomastoideus & scaleni); idem w2.
- Borstspieren: Pectoralis Maior & minor (omgekeerd hoedje), rhomboideï
- Nieuwe stretchoefening - infraspinatus:
o Draai de arm voor het lichaam zo dat de duim zo ver als mogelijk naar beneden draait. Breng de arm voor het lichaam en trek zacht aan de elleboog zodat de arm voor het lichaam komt.
Volgens rekpijn, 5*20 sec, 3x/dag
45
Week 4 Opwarming (5 min)
Mobilisatie oefeningen
= idem week 3 + Geef lichte overdruk op het einde van de beweging indien mogelijk!
1. Hoofd naar voor buigen 2. Halve cirkel voorwaarts
3. Oor naar schouder brengen: LF li-re 4. Draaien van het hoofd naar links-rechts 5. Schouder voorwaarts rollen
6. Schouder achterwaarts rollen
7. Schouders naar voor en achter brengen
Binnen de pijngrens 10 herhalingen per oefening Krachtoefeningen 1. Boogschutter
Neem de weerstandsband in beide handen vast. Doe afwisselend links-rechts een
boogschuttersbeweging: duw de voorste hand uit en trek de elleboog van de achterste arm naar boven tegen een lichte weerstand.
2. In buiklig (probeer indien mogelijk het hoofd niet te draaien):
- Start met de armen afhangend
- Zorg voor een goede positionering van het schouderblad
- Draai vervolgens de duimen naar het plafond en breng de armen naar boven tot horizontaal.
3. In buiklig; idem als hierboven
- Breng de armen naar achter; ongeveer tot horizontaal Binnen de pijngrens 30 herhalingen per zijde 30 herhalingen 30 herhalingen
46
4. Dynamic hug- Breng de weerstandsband achter de rug; rondom de beide ellebogen.
- Neem deze met beide handen vast - Breng de schouderbladen voorwaarts en
opzij terwijl je een O-vorm maakt met de weerstandsband (doe alsof je een boom zou knuffelen) 30 herhalingen Proprioceptieve oefeningen & motorische controle oefeningen - Stabilisatie oefening:
o Breng het schouderblad in de juiste positie
o De armpositie is licht voorwaarts en wat naast het lichaam, de elleboog lager dan de schouder.
o Schud een klein gewichtje (flesje water, halfgevuld) op & neer terwijl je het schouderblad in de juiste positie houdt. o Maak ritmisch kleine bewegingen naar
voor en achter, beweeg terwijl naar boven en onder
10 herhalingen per zijde
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Stretching: - Nekspieren: Trapezius, levator: idem w 1; voorste nekspieren (sternocleidomastoideus & scaleni); idem w2.
- Borstspieren: Pectoralis Maior & minor (omgekeerd hoedje), rhomboideï - Schouderspieren: infraspinatus Volgens rekpijn, 5*20 sec, 3x/dag Week 5 Opwarming (5 min) Mobilisatie oefeningen
= idem week 4 + Geef lichte overdruk op het einde van de beweging indien mogelijk!
1. Hoofd naar voor buigen 2. Halve cirkel voorwaarts
Binnen de pijngrens
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3. Oor naar schouder brengen: LF li-re4. Draaien van het hoofd naar links-rechts 5. Schouder voorwaarts rollen
6. Schouder achterwaarts rollen
7. Schouders naar voor en achter brengen
10 herhalingen per oefening
Krachtoefeningen
1. Start in ruglig, doe de ‘ja’-knik beweging (zoals vroeger aangeleerd met de blauwe
drukmanchet)
Breng vervolgens de kin naar de borst, probeer mooi de volledige nek af te rollen over de tafel tot het hoofd helemaal loskomt.
2. Start in zit.
Breng de weerstandsband achter het hoofd aan, hou de uiteinden vast met de armen vooruit gestrekt.
Doe de ‘chin tuck-beweging’ en breng het hoofd naar achteren tegen de weerstand van de weerstandsband.
3. Start in zit. Neem de weerstandsband vast in beide handen, de armen naast het lichaam (elleboog in de zij).
Breng de beide handen naar buiten (exorotatie van de schouder); tegen de weerstand van de weerstandsband. Binnen de pijngrens 3x 10 herhalingen 10x10 sec 3x10 herhalingen