Keeping It Simple Study (KISS) - Pain Science Education for Patients With Chronic Musculoskeletal Pain Undergoing Community-based Rehabilitation: A Multicenter Randomized Controlled Trial
Phase: NA
Conditions: Musculoskeletal Pain, Chronic Pain
Sponsor: Bettina Eiger

Keeping It Simple Study (KISS) – Pain science education for patients with chronic musculoskeletal pain 
undergoing community-based rehabilitation: A multicenter Randomized Controlled Trial. 
 
Study protocol  version 1 
 
STUDY PROTOCOL 
 
 
 
Project title 
Keeping It Simple Study (KISS) – Pain science education for patients with chronic 
musculoskeletal pain undergoing community-based rehabilitation: A multicenter 
Randomized Controlled Trial. 
 
Primary Investigator (PI) 
Bettina Eiger, PhD-student 
Health Science and Technology 
Aalborg University 
Selma Lagerløfs Vej 249 
9260 Gistrup 
Tlf.: 22 98 89 06 
E-mail: bettinae@hst.aau.dk 
 
 
Project Group 
• Bettina Eiger, Ph.d. Student, Aalborg University 
• Michael Skovdal Rathleff, Professor, Aalborg University 
• David Høyrup Christiansen, Professor, Aarhus University and Central Denmark 
Region  
• Charlotte Overgaard, Professor, University of Southern Denmark  
• Kelly Ickmans, Ass. Professor, Pain in Motion research group (PAIN), Department 
of Physiotherapy, Human Physiology and Anatomy, Faculty of Physical Education & 
Physiotherapy, Vrije Universiteit Brussel, Brussels, Belgium; Movement & Nutrition 
for Health & Performance research group (MOVE), Department of Movement & 
Sport Sciences, Faculty of Physical Education & Physiotherapy, Vrije Universiteit 
Brussel, Brussels, Belgium, Department of Physical Medicine and Physiotherapy, 
Universitair Ziekenhuis Brussel, Brussels, Belgium 
 
 
Northern Region Ethical committee registration number: N-20230073 
Aalborg University Research Ethics Committee Case No: 2024-505-00157  
Clinical Trials NCT06297447 
 
Document date March 6th, 2024 
 
 
 

Keeping It Simple Study (KISS) – Pain science education for patients with chronic musculoskeletal pain 
undergoing community-based rehabilitation: A multicenter Randomized Controlled Trial. 
 
Study protocol  version 1 
 
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Experimental Protocol 
Background  
Problem: The number of patients living with chronic musculoskeletal (MSK) pain has 
steadily increased over the past decade with costs rising equally. Long-standing pain is 
associated with significant maladaptive beliefs about pain, psychological characteristics and 
associated behaviors which involve structural and functional neurobiological characteristics 
which share common pathophysiological mechanisms as chronic pain. Our recent priority 
setting partnership investigated the research priorities from 1000 patients with chronic MSK 
pain, relatives, and clinicians (1). Better pain education was rated as one of the three most 
important research areas (1).    
 
Solution: Pain science education has the potential to target maladaptive psychological and 
behavioral components that may contribute to the maintenance of chronic pain. The KISS 
project will evaluate the effect of a pain neuroscience education program (PNE4Adults) on 
rehabilitation outcomes in patients with chronic MSK pain. This intervention has the potential 
to change beliefs and behaviors surrounding pain in patients with chronic MSK pain. If this 
is successful in disrupting maladaptive cycles contributing to chronicity, this may improve 
outcomes for many thousand citizens. 
 
Introduction: Between 20% and 33% of people across the globe live with a painful 
musculoskeletal (MSK) condition (2). Costs correspond to almost 2% of the gross domestic 
products of European countries (3), posing a challenge for health care systems across the 
world (4,5). Patients with chronic musculoskeletal pain have a high use of healthcare, 
reduced work ability, loss of productivity, and loss of quality of life (6–8). Current care 
guidelines underline that pain science education (PSE) is a vital part of the care delivered 
to people suffering from chronic pain (9–13). PSE is thought in part to attenuate central 
sensitization and improve self-efficacy potentially mediated through decreased pain 
catastrophizing (14) and modulating nocebo-related effects (15). On a patient level, PSE 
has been shown to reduce pain catastrophizing, pain intensity, and fear-avoidance in 
addition to improved physical functioning, self-efficacy, and pain knowledge (16–18).  
Combining exercise and PSE shows greater short-term improvements in pain, disability, 
kinesiophobia, and pain catastrophizing compared to exercise alone (10,19–21) and the 
RESTORE-trial showed the benefit of adding cognitive components (22). On a societal level, 
PSE has further shown to minimize health expenses (16,23). However, some of the 
proposed barriers include training of the therapist delivering the education (24), access to 
training material, time during consultation, and patients’ health literacy levels (25). Even in 
Denmark, a country with a highly educated population, the prevalence of people with 
inadequate health literacy is high, with nearly 4 out of 10 people facing difficulties accessing, 
understanding, appraising, and applying health information (25). This underlines the need 
to consider novel ways of delivering PSE across all levels of health literacy.  
 
Due to the lack of tools to facilitate PSE programs, the investigators adapted an existing 
pain science education program that was developed by Pas et al. (2018) (26) (PNE4Kids) 
to teach children with chronic pain about the underlying biopsychosocial mechanisms 
contributing to pain. The adapted version, named PNE4Adults, consists of a manual for the 
therapist and a board game to enhance engagement and participant involvement. It provides 

Keeping It Simple Study (KISS) – Pain science education for patients with chronic musculoskeletal pain 
undergoing community-based rehabilitation: A multicenter Randomized Controlled Trial. 
 
Study protocol  version 1 
 
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the therapist with a clear “how-to” manual and an accessible way for patients to understand 
the complex concept of pain (27). This new PSE program may also hold promise for adult 
patients with low levels of health literacy and enhance learning due to its practical tools and 
build-in teach-back. The focus on integrating PSE into rehabilitation may enhance the 
therapeutic alliance needed to facilitate the patients’ ability to manage their own symptoms 
(28–31). Our feasibility study in adult patients with chronic MSK pain in community-based 
rehabilitation (Eiger, Rathleff et al. 2024 – under review) showed that PNE4Adults was well 
accepted (100%) and understandable by all (100%) patients, including those with low levels 
of health literacy. Qualitive interviews revealed that patients (irrespective of their health 
literacy) acquired a deeper understanding of their own situation and their pain. This novel 
approach may reduce the inequality in delivering of pain education.  
 
Strategy for Literature Search  
The basis of the study has been found among peer-reviewed articles, publicly available 
material, and Aalborg University’s own research. Ninety-eight unique articles were found, 
and 52 references used (please see the section List of References) for this study which 
form the basis for the research within pain science education in a municipality setting 
rehabilitation.  
 
The literature has been found by reviewing of the search databases: Embase, Cochrane, 
CINAHL, Scopus, Web of Science and Pubmed. The following search words were used in 
combinations for review of the literature: ((('musculoskeletal pain' OR 'msk pain' OR 'chronic pain' 
OR 'locomotor pain' OR 'chronic intractable pain' OR 'chronic persistent pain' OR 'persistent pain') AND 
(('pain science education' OR 'pain neuroscience education' OR 'explain* pain' OR 'therapeutic 
neuroscience education' OR 'pain education' OR 'neurological education' OR 'neurophysiological education' 
OR 'neurophysiology education') OR therapeutic* NEAR/3 educat* OR neurophysiolog* NEAR/3 educat*) 
AND (municipality OR city OR cities OR town OR 'community-based' OR outpatient OR outpatients OR 'out 
patients' OR 'out patient')) AND (2013:py OR 2014:py OR 2015:py OR 2016:py OR 2017:py OR 2018:py OR 
2019:py OR 2020:py OR 2021:py OR 2022:py OR 2023:py)) AND ([adult]/lim OR [aged]/lim OR [middle 
aged]/lim OR [very elderly]/lim OR [young adult]/lim) AND ([danish]/lim OR [english]/lim OR [german]/lim 
OR [norwegian]/lim OR [swedish]/lim).  
 
No Cochrane reviews were available.  
 
Only studies with interest within human research have been used and the studies have 
been produced within the last 10 years.  
Purpose  
Purpose of Sub-project 1 
The primary aim of the KISS-project is to evaluate the added effect of PSE 
(‘PNE4Adults’) to “usual care” compared to “usual care” alone in community-based 
rehabilitation. 
 

Keeping It Simple Study (KISS) – Pain science education for patients with chronic musculoskeletal pain 
undergoing community-based rehabilitation: A multicenter Randomized Controlled Trial. 
 
Study protocol  version 1 
 
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Our hypothesis is PSE plus “usual care” will result in a larger improvement of 
musculoskeletal health (MSK-HQ) after 3 months (primary endpoint) compared to patients 
undergoing “usual care” in the municipality. 
Purpose of Sub-project 2 
The secondary aim is to use a process evaluation to understand how it works, and for 
whom the program works.  
 
The purpose of our process evaluation is to understand how it worked and for whom, and 
not if it worked (32). The investigators will combine in-house registrations from the 
municipality, clinician observations, individual interviews, and focus-group interviews to 
answer what works for whom and under which circumstances. This will give additional 
insights into the novel PSE intervention, shedding light on how it induces change and 
uncovering any potential unintended consequences. This will support future implementation 
pending results. 
 
Subjects 
This randomised controlled parallel group superiority trial will include patients referred to 
rehabilitation at a community-based rehabilitation center with chronic MSK pain. Patients 
are recruited from community-based rehabilitation in Køge, Solrød, and Holbæk 
Municipalities (letters of collaboration has been obtained).  
 
The following selection criteria will be used:  
Inclusion  
• Patients referred for rehabilitation in the municipalities Køge, Holbæk, and Solrød 
• With chronic (>3 months) musculoskeletal pain. 
• Adult patients (≥18 years) – no upper limit (33) 
• Able to understand, speak, and write Danish. 
  
Exclusion 
• 
Known cognitive deficits (e.g., dementia). 
• 
Diagnosed with cancer or other serious pathologies, e.g., cauda equina. 
• 
Pregnancy 
• 
Drug addiction defined as the use of cannabis, opioids, or other drugs.  
• 
Neurologic or psychiatric diagnoses that hinder participation, e.g., stroke and 
borderline. 
• 
Lack of ability to cooperate. 
 
Design and Methods 
Design: 

Keeping It Simple Study (KISS) – Pain science education for patients with chronic musculoskeletal pain 
undergoing community-based rehabilitation: A multicenter Randomized Controlled Trial. 
 
Study protocol  version 1 
 
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This study will be a multicentre randomised controlled, superiority trial with a 2-group 
parallel design. Reporting of the protocol follows the SPIRIT statement (34) and the 
TIDieR (35). The preparation of the trial, including publishing this trial protocol, is done in 
accordance with the PREPARE Trail guide (36). Before inclusion of the first participant, 
the trial will be registered on ClinicalTrials.gov. 
 
 
Study setting: 
The study will be coordinated from Department of Health Science and Technology at 
Aalborg University. Participants will be recruited from the municipality rehabilitation centres 
in Køge, Solrød, and Holbæk, and the interventions will be implemented in all three 
locations.  
 
Project team:  
The principal investigator (BE) is responsible for planning the trial. BE has more than 27 
years of clinical experience as a physiotherapist, has a Master of Pain Science and 
Multidisciplinary Pain Management and is now in the process of conducting a PhD study. 
BE will train the physiotherapists delivering the intervention and will supervise them during 
the project. Prof. Michael Skovdal Rathleff and David Høyrup Christiansen have extensive 
research experience and Assoc. Prof. Kelly Ickmans is the original co-developer of 
PNE4Kids. Prof. Charlotte Overgaard has extensive experience in evaluating complex 
interventions in health care.   
 
Measurement methods: 
Data collection will be performed via online questionnaires at baseline, 6 weeks, 3 months, 
and 6 months sent to the participants’ digital mailbox, e-Boks, which is accessed with 
MitID to ensure identity. Alternatively, if they don’t have online access, the patients can 
arrange to come to the rehabilitation centre and receive help filling out the questionnaires 
online. Primary outcome is musculoskeletal Health (MSK-HQ) at primary endpoint at 3 
months. All survey data will be collected through Research Electronic Data CAPture 
(REDCap) tools hosted at Aalborg University and stored on a secure server.  
At baseline (T1), socio-demographic data will be collected: age, sex, marital status, work 
status, education level. Additionally, diagnoses and co-morbidities, pain duration, self-report 
pain medication usage, and sick-leave, Central Sensitization Inventory (CSI) (37) and Brief 
Health Literacy scale for Adults (B-HLA)(38) to characterize their clinical condition will be 
collected. Any adverse events will be noted by the physiotherapist. The recommendations 
from the IMMPACT initiate on outcomes for trials on chronic pain will be used (39). 
  
 
 
 

Keeping It Simple Study (KISS) – Pain science education for patients with chronic musculoskeletal pain 
undergoing community-based rehabilitation: A multicenter Randomized Controlled Trial. 
 
Study protocol  version 1 
 
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Primary outcome will be Musculoskeletal Health measured with the Musculoskeletal Health 
Questionnaire (MSK-HQ) (40) at 3 months (T3). Secondary endpoints will be at 6 weeks 
(T2) and 6 months (T4). 
 
Secondary outcomes include mean pain intensity (average of two numeric rating scales – 
most severe during past 24 hours, and average during past 14 days, on a 0-10 numeric 
rating scale) (41), pain interference (Interference part of the Brief Pain Inventory (BPI)) 
(42,43), concept of pain (Concept of Pain Inventory – adult (COPI-adult(DK))) (44), pain 
catastrophizing (Pain Catastrophizing Scale (PCS)) (45), pain self-efficacy (Pain Self-
Efficacy Questionnaire (PSEQ)) (46), fear of movement (Tampa Scale of Kinesiophobia 
(TSK-11)) (47), patient specific functional limitations (Patient-Specific Functional Scale, 0-
10 scale) (48,49)), patients impression of change (Global Impression of Change scale 
(GICS) (39) as a single-item rating by participants using a 7-point rating scale with the 
options “very much improved,” “much improved,” “minimally improved,” “no change,” 
“minimally worse,” “much worse,” and “very much worse”), patient satisfaction with current 
symptom state (Patient Acceptable Symptom State (PASS)) with the wording: “Taking into 
account your level of pain and also your functional impairment, if you were to remain for the 
next few months as you are today, would you consider that your current state is 
satisfactory?” (50), any adverse events and the time spent on consultations. As 
recommended for complex interventions (51), a qualitative, process evaluation in addition 
to the main quantitative analysis will be performed and a subsection of the included patients 
will be invited to participate in an interview. The investigators expect that this will include 12-
14 patients. In addition, at each site the leaders and 1-2 of the physiotherapists delivering 
the intervention will be interviewed. 
 
Randomization and blinding: 
After filling out informed consent and baseline questionnaires, participants will be 
automatically randomized using REDCap. Randomization will be stratified by cite. Block 
randomization in random concealed block sizes of 4 to 12 (1:1) into two parallel groups is 
used to avoid imbalance in the randomization between intervention groups. A researcher, 
not otherwise affiliated with the study will generate the allocation sequence using 
sealedenvelope.com and upload it to REDCap and is the only person who will know the 
block sizes.  
 
The randomization will be coded (Group 1 or 2), thus the primary investigator (BE) will not 
know the code to the groups.   
 
As patients are engaging in a behavioural intervention, they are not blind to allocation, and 
neither are the physiotherapists delivering the intervention/ usual care. Treatment 
expectation is measured after randomization by a single tailored question: “How confident 
are you that this treatment option will be successful in improving your MSK pain”? The 
person conducting the analysis and primary investigator (BE) will remain blinded. The 
intervention is an add-on to “usual care”. Pragmatically, there are no restrictions to “usual 
care” in either group. It is determined by patient preferences, physiotherapists’ clinical 
reasoning, and available resources.  
 
 
 

Keeping It Simple Study (KISS) – Pain science education for patients with chronic musculoskeletal pain 
undergoing community-based rehabilitation: A multicenter Randomized Controlled Trial. 
 
Study protocol  version 1 
 
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Control group:  
The control group receives unrestricted “usual care”. It could include a patient interview with 
individual goal setting and subsequent rehabilitation using cardio and strengthening 
exercises towards achieving the determined goals. It will be delivered by an authorized 
physiotherapist, and the intervention is determined by patient preferences, physiotherapist’s 
clinical reasoning, and available resources.  
 
Intervention: 
In the intervention group, the participants will receive an add-on individualized PSE in 
addition to the usual care with the PNE4Adults resource. The PNE4Adults session will follow 
the developed manual (http://www.paininmotion.be/pne4kids) and will be delivered by a 
physiotherapist in two sessions of each 30-45 minutes, shortly following the first meeting. 
Firstly, the function of a normal pain system is introduced, with examples of the pain being 
overly or under protective. Then, the patient teaches back giving the therapist the 
opportunity to evaluate the understanding and, if necessary, repeat essential key messages. 
Secondly, the sensitized pain system is explained. Thirdly, the subject is asked to reflect on 
this new information in relation to his/her own situation. Subsequently, the new knowledge 
is integrated in “usual care” with any additional measures that need to be included, e.g., 
graded exposure, stress relief, graded activity, and cognitive therapies. 
 
Physiotherapists delivering the intervention:  
The physiotherapist delivering the intervention will be five physiotherapists from Køge, four 
from Holbæk, and two from Solrød. The physiotherapists have been selected by the 
leaders at each site. Pragmatically, no prior knowledge of pain science or level of 
experience was asked beforehand, but all are licensed physiotherapists. The “usual care” 
delivered to the control group, will be delivered by other physiotherapist in the 
municipalities, and not by any of the above-mentioned physiotherapists trained in 
delivering the intervention. As far as possible, the patients in the intervention group will be 
separated from the control group.  
 
Description of the competency building for the physiotherapists intended to deliver the 
PNE4Adults intervention: 
Five full days of teaching is planned, with 7.5 hours of teaching in person per day. In 
addition, follow-up sessions are planned throughout the course of the RCT to ensure 
fidelity to treatment and to support the physiotherapist in delivering the novel intervention.  
  
The subjects being covered are: 
 
• Pain as a truly bio-psycho-social experience. 
• The definition of pain from IASP 2020 including footnotes. 
• Classification of pain as per ICD-11. 
• Neurophysiology of nociceptive pain, the sensitized pain system and descending 
modulation.  
• Facilitatory and inhibitory contextual factors (internal, external, and relational 
factors). 
• Therapeutic alliance, theory and how to enhance this. 

Keeping It Simple Study (KISS) – Pain science education for patients with chronic musculoskeletal pain 
undergoing community-based rehabilitation: A multicenter Randomized Controlled Trial. 
 
Study protocol  version 1 
 
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• Motivational interviewing and cognitive behavioural approaches to facilitate 
behavioural change. 
• Planning exercise therapies to chronic pain patients with different pain profiles 
(localized or generalized pain, pronociceptive), including introduction to pacing, 
graded activity and in vivo exposure. 
• A special focus on “Plain talking” to include those with low levels of health literacy. 
• The education will include lectures with power points (that are handed out), videos, 
but also a strong focus on practical learning and a reflection on one’s own practise.  
 
The physiotherapists will practice using the PNE4Adults as the tool to educate patients on 
pain science and will also address ways to support learning during rehabilitation. 
Motivational interviewing and shared decision making will be practiced with a reflective 
team to give constructive feedback. Cases will be presented to encourage clinical 
reasoning in introducing physical activity to different types of patients and will be 
discussed to enhance reflective learning. The full days of teaching are planned with 
intervals of 2-3 weeks to ensure practical learning and practice in clinical situations 
following the more theoretical learning situations. Supervision groups are encouraged at 
each site.   
Risks, Side Effects and Disadvantages 
Safety and adverse events: 
Adverse events are not expected, as the intervention is educational (52). However, 
information will be gathered on any adverse events in agreement with the IMMPACT 
recommendations (39,53). Muscle soreness or mild increase in pain in considered normal 
when initiating physical rehabilitation and is not considered an adverse event. There will be 
a Safety Monitoring Committee (SMC). 
 
Safety Monitoring Committee: 
Ensuring the safety of all participants in this study is important. With the single purpose of 
handling any adverse events a Safety Monitoring Committee (SMC) will be set up. The SMC 
will consist of the principal investigator (BE), main supervisor (MSR) and a medical doctor, 
Jens Lykkegaard Olesen, who is not otherwise involved in the study. In case of an adverse 
event, there will be an online meeting at which the event will be assessed and possibly 
graded (according to the Common Terminology Criteria for Adverse Events v4.03 (54)), the 
relation to the study determined, assisting the clinician in determining course of action, and 
deciding whether the participant can continue or should be withdrawn from the study. Action 
and treatment of adverse events will start immediately following the usual treatment 
protocols. Muscle soreness and slight increase in existing pain is considered a normal 
reaction to initiating physical rehabilitation and is not considered an adverse event. Once 
annually a list of any adverse events will be reported to the Ethical Committee. 
 
Statistics 
Sample size and statistical plan: The sample size calculation was performed using Stata 
vers 16.0 and is based on our feasibility study and done in collaboration with a statistician. 
Our estimate of a sample size is based on the ability to detect a clinically relevant difference 

Keeping It Simple Study (KISS) – Pain science education for patients with chronic musculoskeletal pain 
undergoing community-based rehabilitation: A multicenter Randomized Controlled Trial. 
 
Study protocol  version 1 
 
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in MSK-HQ of 8.6 points between the two groups (40). To estimate a difference of 8.6 points 
(40) , with a common standard deviation of 15 points, a two-sides type I error rate of 0.05, 
and a power of 95%, the sample size was estimated as 49 participants per group. 
Considering an attrition rate of 15% and a potentially larger variation than previous studies 
due to heterogeneity of participants, this requires 70 participants per group. The 
investigators anticipate that a sample-size of 70 participants per group will be sufficient to 
test for clinically meaningful differences between groups and ensure statistical power even 
if the variance in the outcome is larger than anticipated. To allow for explorative subgroup 
analyses on the interaction effect of health literacy the investigators will increase this 
sample-size to 100 patients per arm. Statistical analyses will be performed blinded 
according to a pre-established analysis plan. The primary intention-to-treat analysis will 
investigate the between-group difference in our primary outcome. The investigators plan to 
use a linear mixed effects model with participant as random effect and time (6 weeks post 
randomization and follow-up at 3 and 6 months), group allocation (novel PNE4Adults + usual 
care vs usual care), study site, and baseline value of the outcome as fixed effects. 
Ethical Considerations 
Before initiating this study, the protocol has been evaluated by The North Denmark Region 
Committee on Health Research Ethics, and The Scientific Ethics Committee for Region 
North Jutland has at its meeting on 23 January 2024, concluded that the project is not 
covered by the Committees Act (Act no. 1338 of 01/09/2020) definition of a health science 
research project and must therefore not be notified to and approved by the committee, cf. 
section 14, subsection of the Committees Act. 1, cf. section 2, nos. 1-3. The Aalborg 
University Research Ethics Committee has approved this study, Case No: 2024-505-
00157. 
 
As this is an add-on to usual care, all participants will receive an intervention at least as 
good as standard care today. 
 
The investigators wish to implement the PNE4Adults pain science education tool into 
clinical practice to optimize rehabilitation outcomes in adult patients with chronic pain 
including those with low degrees of health literacy. The intervention is educational and 
there is no risk of adverse events. However, according to IMMPACT recommendations 
(39), information on any adverse events will be gathered in this study and any that may 
occur will be handled. It is an add-on to “usual care” with the hope it will improve 
rehabilitation outcomes. The investigators follow the Helsinki Declaration in the planning 
and conducting of this study. 
 
All survey data will be collected through Research Electronic Data CAPture (REDCap) 
tools hosted at Aalborg University and stored on a secure server. The study will be 
reported on ClinicalTrails.gov and has been registered internally at Aalborg University, and 
the protocol has been approved by the Ethical Committee at Aalborg University prior to 
inclusion of the first patient. 

Keeping It Simple Study (KISS) – Pain science education for patients with chronic musculoskeletal pain 
undergoing community-based rehabilitation: A multicenter Randomized Controlled Trial. 
 
Study protocol  version 1 
 
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Insurance 
The subjects are covered by the Danish Patient Compensation Association (Patient 
erstatningen). 
Personal Data 
Data will be stored after termination of the project. These data can only be used for the 
interpretation of this project and will therefore not be of interest to third party.  
 
Data are stored in accordance with the stipulations in the General Data Protection 
Regulation and the Danish Data Protection Act. Data will be stored in REDCap hosted at 
Aalborg University. 
 
The project is registered through internal registration in the Article 30 Register of AAU.  
Information from Medical Charts 
 
Before informed consent, the administrative personnel at each rehabilitation centre will 
extract information from the referrals from the hospital and/or medical charts to identify 
eligible participants for the study. The following information will be retrieved: Age, reason 
for referral, indications of MSK chronic pain, information on cancer, serious pathologies, 
neurological disorders, pregnancy, drug addiction and cognitive deficits. The investigators 
expect to screen a total of 300 referrals to include 200 participants. In the municipality only 
see the referral can be seen, not the medical charts.  
 
After enrolment in the study, the following information will be retrieved from the referral of 
the participants: Diagnose, comorbidities and time and type of contact during rehabilitation 
in the municipality and dose of the intervention. Everything else is self-report.  
 
The information from the medical charts is used to characterize their clinical condition.  
 
The consent from the participant gives the principal investigator (Bettina Eiger, 
Musculoskeletal Health and Implementation, Department of Health Science and 
Technology, Aalborg University), sponsor (Michael Skovdal Rathleff, Head of 
Musculoskeletal Health and Implementation, Department of Health Science and 
Technology, Aalborg University) and sponsor’s representatives, and any control authority 
direct access to obtain information in the subject’s medical chart, etc. (including electronic 
medical chart) to see information about the health conditions of the subject, which is 
necessary to conduct the research project and to conduct the mandatory control schemes, 
including self-regulation, quality control and monitoring. 
Project Economy 
The experiment has been initiated by Bettina Eiger, PhD Student, and Michael Skovdal 
Rathleff, Professor, both Department of Health Science and Technology, Aalborg 
University. 
 

Keeping It Simple Study (KISS) – Pain science education for patients with chronic musculoskeletal pain 
undergoing community-based rehabilitation: A multicenter Randomized Controlled Trial. 
 
Study protocol  version 1 
 
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The experiment is financed with DKK 100,000 from Danske Fysioterapeuter, DKK 400,000 
from Helsefonden, DKK 2,150,965 from Karen Elise Jensens Fond and DKK 400,000 from 
Køge Kommune. The amounts are administered by Træningsenheden, Køge Kommune. 
 
None of the researchers have financial interest in the experiment. Bettina Eiger is 
employed at Køge Kommune, but Køge Kommune will have no influence in analysing the 
results. 
Compensation to Subjects 
The subjects will not receive compensation for the participation in the experiment.  
Publishing of Results 
All results of the project will be published regardless of the outcome of the project.  
Time Schedule 
Recruitment is set to commence earliest on March 7th, 2024, and terminate when 200 
patients have completed the follow-up. The investigators expect to have included 200 
patients per March 1st, 2025, and have completed follow-up by December 1st, 2025.  
Guidelines for Oral Information and Informed Consent 
Summoning Potential Subjects 
When potential subjects are addressed by the staff at the rehabilitation centres, the 
following should be stated:  
 
• That it is a request for participation in a scientific research project. 
• The purpose of the project. 
• That participation is voluntary and that the subject can withdraw from the project at 
any time without consequences. 
• That the potential subject has time to consider his/her participation before giving 
consent to participation in the project and that the potential subject is welcome to 
ask a family member or a friend to join the information meeting. The potential 
volunteer will receive the leaflet “The Rights of a Trial Subject in a Health Scientific 
Research Project”/ "Forsøgspersonens rettigheder i et sundhedsvidenskabeligt 
forskningsprojekt" which includes information on confidentiality, right of access to 
documents and right to complain.  
• That the material “Information for Participants”/ ”Deltagerinformation” will be 
forwarded in e-Boks (or per mail, if they are exempt from e-Boks) to the potential 
subject for him/her to know more about the project before the information meeting.  
• Finally, time for the information meeting is arranged. 
 

Keeping It Simple Study (KISS) – Pain science education for patients with chronic musculoskeletal pain 
undergoing community-based rehabilitation: A multicenter Randomized Controlled Trial. 
 
Study protocol  version 1 
 
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The Information Meeting  
The information meeting is held in a quiet room where it is possible to have an 
uninterrupted conversation. The information meeting is held by the person responsible for 
the project or a project physiotherapist, who has been authorized to give the information.  
 
The meeting is to include the following information/questions:  
 
• Participation is voluntary and the subject can withdraw from the project at any time 
without consequences. 
• The subject has time to consider his/her participation before giving ethical consent 
to participation in the project, and the subject is welcome to ask a family member or 
a friend to come to the information meeting.  
• The subject is asked whether he/she wants a family member/friend to be present at 
the meeting.  
• The purpose of the experiment is presented, and it is explained how the experiment 
is conducted. The “Information for Participants”/”Deltagerinformation”, which has 
been sent to the potential subject in advance, is the starting point for the information 
meeting.  
• The leaflet “The Rights of a Trial Subject in a Health Scientific Research Project”/ 
"Forsøgspersonens rettigheder i et sundhedsvidenskabeligt forskningsprojekt" is 
handed over. It is explained that it includes information on confidentiality, right of 
access to documents and right to complain.  
• The subject is asked whether he/she has read “Information for Participants”/ 
”Deltagerinformation”. If this is not the case, we will ask the subject to read it. 
• When it has been ensured that the subject has read the “Information for 
Participants”/”Deltagerinformation”, he/she is asked whether he/she has questions 
about the experiment.  
• It is underlined that participation is voluntary, and that the subject has time to 
consider his/her participation (please note that The National Committee on Health 
Research Ethics recommends 24 hours of deliberation time) 
• Again, it is underlined that participation is voluntary and that the subject can 
withdraw his/her consent at any time without consequences.  
• The subject is informed that if he/she does not need time to consider the 
participation, the ethical consent can be given at the information meeting.  
• In case the potential subject needs time to consider the participation, he/she is 
again informed about the right to consider the participation and the information 
meeting is terminated. Then, a new information meeting will be scheduled when the 
potential subject indicates by phone or email that he/she has had adequate time to 
consider the potential participation.  
• When the subject has given consent to participate, time/place for the experiment is 
agreed.  
• Finally, information about the contact person of the experiment is given (it is shown 
to the subject that the name and contact details appear from the “Information for 
Participants”/”Deltagerinformation”) and it is informed that this person can be 
contacted at any time if further questions should arise.  
 
 

Keeping It Simple Study (KISS) – Pain science education for patients with chronic musculoskeletal pain 
undergoing community-based rehabilitation: A multicenter Randomized Controlled Trial. 
 
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