Musculoskeletal PainNCT05235152
Group-based Exercise Training Programs for Military Members With Musculoskeletal Conditions
A study testing Usual individual physiotherapy care and Group-supervised physiotherapy training programs in people with Musculoskeletal Pain and Low Back Pain, run by Laval University at 1 site in Canada.
Trial summary
This randomized controlled trial will compare the mid- and long-term effects of group-based training programs with usual individual physiotherapy care for the treatment of musculoskeletal disorders in military. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Musculoskeletal Pain, Low Back Pain, Rotator Cuff Tendinitis
- What is being tested?
- Usual individual physiotherapy care and Group-supervised physiotherapy training programs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 28 Jan 2022to 31 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 18-60 years
- Present one of the four targeted musculoskeletal disorders:
- Low back pain:
- Inclusion - 1) Low back pain with or without radiation to the lower limbs, 2) minimal score of 17% on the Modified Oswestry Disability Index (ODI).
- Exclusion - 1) history of surgery or fracture to the spinal column, 2) signs of upper motor neuron lesions (bilateral paresthesia, hyperreflexia or spasticity) or other red flags (e.g. fracture).
- Patellofemoral pain syndrome:
Show all 14Show fewer
- Inclusion - 1) anterior knee pain during running or during at least two activities among: kneeling, squatting, and resisted knee extension 2) score lower than 85/100 on the Knee Outcomes Survey - Activity of Daily Living Scale (KOS- ADLS).
- Exclusion - 1) history of knee surgery or patellar dislocation; 2) pain believed to originate either from meniscus (presence of joint line fullness and tenderness, McMurray sign, and positive Thessaly test) or from any knee ligament.
- Rotator cuff-related shoulder pain:
- Inclusion - 1) at least one positive finding in each of the following categories: a) painful arc of movement; b) positive Neer's or Kennedy-Hawkins Test; c) pain on resisted external rotation, resisted abduction or Empty Can Test 2) minimal score of 14 points on the Disabilities of the Arm, Shoulder and Hand (QuickDASH).
- Exclusion - 1) history of shoulder surgery, fracture, capsulitis, or dislocation, 2) full thickness rotator cuff tear identified by imagery or clinical tests 3) cervicobrachialgia or shoulder pain reproduced by neck movements.
- Lateral ankle sprain:
- Inclusion - 1) unilateral lateral ankle sprain of <6 weeks, 2) minimal score of 9 points on the Lower Extremity Functional Scale (LEFS).
- Exclusion - 1) ankle fracture, 2) lateral ligaments not the principal injury (a high ankle/tibiofibular sprain).
Who cannot join
- Are unavailable to participate in a 12-week intervention;
- Have a diagnosis of rheumatoid, inflammatory, neurological or neurodegenerative disease;
- Received a corticosteroid injection in the previous 6 weeks in the affected region;
- Have had more than 6 months of work restriction for their current musculoskeletal pain;
- Acute conditions (Constant and intense pain [>5/10];Severely limited range of motion [more than 50% in at least 2 directions]; Obvious lateral shift for low back pain or Unable to bear weight [for lateral ankle sprain])
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Laval University
Québec, G1V 0A6
Jean-Sébastien Roy, PhD, (418) 529 9141 ext. 6005, Jean-Sebastien.Roy@fmed.ulaval.ca
Frédérique Dupuis, PhD Student, 5819997113, frederique.dupuis.1@ulaval.ca
About this study
Official title: Group-based Exercise Training Programs for Military Members Presenting Musculoskeletal Disorders - A Pragmatic Randomized Controlled Trial
This randomized controlled trial will compare the mid- and long-term effects of group-based training programs with usual individual physiotherapy care for the treatment of musculoskeletal disorders in military. One hundred and twenty soldiers presenting one of the four targeted musculoskeletal disorders (low back pain, rotator cuff related pain, patellofemoral pain syndrome or lateral ankle sprain) will be recruited and randomly assigned to either a 12-weeks group-based training program or 12-weeks usual individual physiotherapy care.
Read the detailed description
Musculoskeletal disorders are a leading cause of morbidity and the most prevalent source of disability among soldiers. Their high prevalence in armed forces and limited resources have led to problems related to access to physical rehabilitation care. To increase access, supervised group-based exercise programs for the most prevalent musculoskeletal disorders (low back pain, patellofemoral pain, rotator cuff-related shoulder pain or lateral ankle sprain) have been developed at a Canadian Armed forces (CAF) base, but their effectiveness has not been evaluated. The primary objective of this randomized controlled trial is to evaluate the mid- and long-term effects of these group-based training programs on pain severity and functional limitations, in comparison with usual individual physiotherapy care. Secondary objectives include comparing both interventions in terms of health-related quality of life, pain-related fear, and patients' satisfaction.
One hundred and twenty soldiers with a new medical referral for physiotherapy services for one of the four targeted musculoskeletal disorders will be consecutively recruited. They will be randomly assigned to either group-based training program or usual individual physiotherapy care, and will take part in the assigned 12-week intervention. There will be four evaluation sessions over 26 weeks (baseline, week 6, 12 and 26). At each follow-up, functional limitations, pain severity, health-related quality of life and pain-related fears will be assessed. Patients satisfaction with treatment will also be evaluated at the end of the intervention period. A two-way repeated measures ANOVA will be used to analyze and compare the effects of the interventions.
The results of this randomized controlled trial will determine the effectiveness of group-based training programs compared to usual individual physiotherapy care. This new intervention model could represent an efficient, and more pro-active approach to manage a higher number of soldiers with musculoskeletal disorders. It could improve access to physical rehabilitation care and improve the health of soldiers.
- Conditions
- Musculoskeletal Pain, Low Back Pain, Rotator Cuff Tendinitis, Patellofemoral Pain Syndrome, Ankle Sprains
- Being tested
- Usual individual physiotherapy care, Group-supervised physiotherapy training programs
- Medical subject headings
- Musculoskeletal Pain, Low Back Pain, Rotator Cuff Injuries, Patellofemoral Pain Syndrome, Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual individual physiotherapy careOther
Usual and individual physiotherapy care guidelines were developed through a round-table discussion involving experts in musculoskeletal health. From the round-table discussion, the consensus as reflecting best-practices for the rehabilitation of musculoskeletal rehabilitation supported an active exercise rehabilitation approach which includes strengthening and neuromuscular training exercises. Furthermore, the following treatments are considered in addition to active exercises:
- Range of motion: active, active-assisted, passive, repeated movements (Mulligan or McKenzie);
- Stretching / manual therapy: mobilizations, manipulation, neural mobility, active release therapy;
- Individual proprioceptive training.
Group-supervised physiotherapy training programsOther
Three group-supervised physiotherapy training programs (The lumbar, the upper extremity and the lower extremity training programs) were developed for military members with musculoskeletal conditions. They are composed of stations that each include several exercises of varying levels of difficulty. Group size will vary between 5 to 20 participants for one physiotherapist, and each military member performs his/her own exercises. During a typical session, the participant and therapist will choose one exercise to perform per station according to two main criteria: severity of the condition and the ability to perform the exercises optimally. The level of supervision is adapted to the participant's needs and performance. Progression in the programs leads to the execution of exercises that simulate functional and occupational tasks.
| Study group | Role | What they receive |
|---|---|---|
| Usual individual physiotherapy care | Active comparator | Participants with either low back pain, rotator cuff related pain, patellofemoral pain syndrome or lateral ankle sprain will received usual/individual physiotherapy care over a period of 12-weeks for the treatment of their musculoskeletal conditions if randomized in this group. Receives: Other: Usual individual physiotherapy care |
| Group-supervised physiotherapy training programs | Experimental | Participants with either low back pain, rotator cuff related pain, patellofemoral pain syndrome or lateral ankle sprain will received group-supervised physiotherapy training programs over a period of 12-weeks for the treatment of their musculoskeletal condition if randomized in this group. Receives: Other: Group-supervised physiotherapy training programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional limitations
Pain-related functional limitations will be measured with the Pain Interference subscale of the Brief Pain Inventory - Short Form (BPI). The Pain Interference subscale is recommended for assessment of pain-related functional limitations and includes seven items that measure the level of interference with function caused by pain using 0 (no interference) to 10 (complete interference) rating scales.
Measured: Week 26
Secondary outcomes (25)
Functional limitations
Pain-related functional limitations will be measured with the Pain Interference subscale of the Brief Pain Inventory - Short Form (BPI). The Pain Interference subscale is recommended for assessment of pain-related functional limitations and includes seven items that measure the level of interference with function caused by pain using 0 (no interference) to 10 (complete interference) rating scales.
Measured: Week 6 (mid-intervention)
Functional limitations
Pain-related functional limitations will be measured with the Pain Interference subscale of the Brief Pain Inventory - Short Form (BPI). The Pain Interference subscale is recommended for assessment of pain-related functional limitations and includes seven items that measure the level of interference with function caused by pain using 0 (no interference) to 10 (complete interference) rating scales.
Measured: Week 12 (end of intervention)
Pain severity
Pain severity will be measured with the Pain Severity subscale of the Brief Pain Inventory - Short Form (BPI). The Pain Severity subscale of the BPI includes four items that measure pain intensity using 0 (no pain) to 10 (pain as bad as you can imagine) rating scales.
Measured: Week 6 (mid-intervention)
Pain severity
Pain severity will be measured with the Pain Severity subscale of the Brief Pain Inventory - Short Form (BPI). The Pain Severity subscale of the BPI includes four items that measure pain intensity using 0 (no pain) to 10 (pain as bad as you can imagine) rating scales.
Measured: Week 12 (end of intervention)
Pain severity
Pain severity will be measured with the Pain Severity subscale of the Brief Pain Inventory - Short Form (BPI). The Pain Severity subscale of the BPI includes four items that measure pain intensity using 0 (no pain) to 10 (pain as bad as you can imagine) rating scales.
Measured: Week 26
Health-related quality of life
Health-related quality of life will be measured with the five-level version of EQ-5D (EQ-5D-5L). The EQ-5D-5L is a generic health-related quality of life (HRQoL) questionnaire that contains five questions covering five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question is rated on a five-point scale from 1 (no problems) to 5 (unable to perform). The combined dimensions describe 55 = 3125 theoretically possible states of health that can be converted into a weighted index score ranging from 0 to 1.
Measured: Week 6 (mid-intervention)
Health-related quality of life
Health-related quality of life will be measured with the five-level version of EQ-5D (EQ-5D-5L). The EQ-5D-5L is a generic health-related quality of life (HRQoL) questionnaire that contains five questions covering five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question is rated on a five-point scale from 1 (no problems) to 5 (unable to perform). The combined dimensions describe 55 = 3125 theoretically possible states of health that can be converted into a weighted index score ranging from 0 to 1.
Measured: Week 12 (end of intervention)
Health-related quality of life
Health-related quality of life will be measured with the five-level version of EQ-5D (EQ-5D-5L). The EQ-5D-5L is a generic health-related quality of life (HRQoL) questionnaire that contains five questions covering five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each question is rated on a five-point scale from 1 (no problems) to 5 (unable to perform). The combined dimensions describe 55 = 3125 theoretically possible states of health that can be converted into a weighted index score ranging from 0 to 1.
Measured: Week 26
Pain-related fear
Pain-related fear will be measured with the Tampa scale of kinesiophobia. The Tampa scale of kinesiophobia is a 11-item scale measuring beliefs and behaviours related with pain, specially focusing on beliefs that pain is damaging and painful movements should be avoided.
Measured: Week 6 (mid-intervention)
Pain-related fear
Pain-related fear will be measured with the Tampa scale of kinesiophobia. The Tampa scale of kinesiophobia is a 11-item scale measuring beliefs and behaviours related with pain, specially focusing on beliefs that pain is damaging and painful movements should be avoided.
Measured: Week 12 (end of intervention)
Pain-related fear
Pain-related fear will be measured with the Tampa scale of kinesiophobia. The Tampa scale of kinesiophobia is a 11-item scale measuring beliefs and behaviours related with pain, specially focusing on beliefs that pain is damaging and painful movements should be avoided.
Measured: Week 26
Satisfaction with treatment - PASS
Patients satisfaction with treatment will be assessed using the Patient Acceptable Symptom State (PASS). It asks patients if they are satisfied with their current state or not and to rate their satisfaction on a 0-10 numeric scale (0 representing not satisfied at all, and 10 very much satisfied).
Measured: Week 12 (end of intervention)
Satisfaction with treatment - Likert Scale
Participants will be asked to rate their satisfaction with treatment received using a three-item Likert scale (''not satisfied'', ''satisfied'' or ''very much satisfied''), their satisfaction with the frequence of treatments (''not enough'', ''just right'' or ''too much''), their satisfaction with the duration of treatments (''too short'', ''long enough''or ''too long'') and their satisfaction with the time spent with the physical therapist during the treatments ("not enough'', ''just right'' or ''too much'').
Measured: Week 12 (end of intervention)
Low back pain-specific symptoms and functional limitations
Low back pain-specific symptoms and functional limitations will be evaluated for soldiers with low back pain with the Oswestry Disability Index (ODI) questionnaire. The ODI is a 10-item questionnaire that assesses the interference of low back pain with activities of daily living using 0 (no difficulty) to 5 (incapacity) rating scales.
Measured: Week 6
Low back pain-specific symptoms and functional limitations
Low back pain-specific symptoms and functional limitations will be evaluated for soldiers with low back pain with the Oswestry Disability Index (ODI) questionnaire. The ODI is a 10-item questionnaire that assesses the interference of low back pain with activities of daily living using 0 (no difficulty) to 5 (incapacity) rating scales.
Measured: Week 12
Low back pain-specific symptoms and functional limitations
Low back pain-specific symptoms and functional limitations will be evaluated for soldiers with low back pain with the Oswestry Disability Index (ODI) questionnaire. The ODI is a 10-item questionnaire that assesses the interference of low back pain with activities of daily living using 0 (no difficulty) to 5 (incapacity) rating scales.
Measured: Week 26
Shoulder disorders-specific symptoms and functional limitations
Shoulder-specific symptoms and functional limitations will be evaluated for soldiers with rotator cuff related pain using the shortened version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH). It is an 11-item questionnaire addressing the level of difficulty in performing daily activities and the severity of the symptoms of the upper limbs using 0 (no difficulty or no symptoms) to 5 (incapacity or important symptoms) rating scales.
Measured: Week 6
Shoulder disorders-specific symptoms and functional limitations
Shoulder-specific symptoms and functional limitations will be evaluated for soldiers with rotator cuff related pain with the shortened version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH). It is an 11-item questionnaire addressing the level of difficulty in performing daily activities and the severity of the symptoms of the upper limbs using 0 (no difficulty or no symptoms) to 5 (incapacity or important symptoms) rating scales.
Measured: Week 12
Shoulder disorders-specific symptoms and functional limitations
Shoulder-specific symptoms and functional limitations will be evaluated for soldiers with rotator cuff related pain with the shortened version of the Disabilities of the Arm, Shoulder and Hand (QuickDASH). It is an 11-item questionnaire addressing the level of difficulty in performing daily activities and the severity of the symptoms of the upper limbs using 0 (no difficulty or no symptoms) to 5 (incapacity or important symptoms) rating scales.
Measured: Week 26
Knee disorders-specific symptoms and functional limitations
Knee-specific symptoms and functional limitations will be evaluated for soldiers with patellofemoral pain syndrome using the Knee Outcome Survey Activities of Daily Living Scale (KOS-ADLS). It is a 14-item knee-specific questionnaire that evaluates symptoms and functional limitations experienced during activities of daily living in individuals with various knee disorders using 5 (no difficulty) to 0 (incapacity) rating scales.
Measured: Week 6
Knee disorders-specific symptoms and functional limitations
Knee-specific symptoms and functional limitations will be evaluated for soldiers with patellofemoral pain syndrome using the Knee Outcome Survey Activities of Daily Living Scale (KOS-ADLS). It is a 14-item knee-specific questionnaire that evaluates symptoms and functional limitations experienced during activities of daily living in individuals with various knee disorders using 5 (no difficulty) to 0 (incapacity) rating scales.
Measured: Week 12
Knee disorders-specific symptoms and functional limitations
Knee-specific symptoms and functional limitations will be evaluated for soldiers with patellofemoral pain syndrome using the Knee Outcome Survey Activities of Daily Living Scale (KOS-ADLS). It is a 14-item knee-specific questionnaire that evaluates symptoms and functional limitations experienced during activities of daily living in individuals with various knee disorders using 5 (no difficulty) to 0 (incapacity) rating scales.
Measured: Week 26
Ankle disorders-specific symptoms and functional limitations
Ankle-specific symptoms and functional limitations will be evaluated for soldiers with lateral ankle sprain using the Lower Extremity Functional Scale (LEFS). It is a 20-item questionnaire assessing the impairment of the lower-extremity musculoskeletal system in everyday activities using a 0 (incapacity) to 4 (no difficulty) rating scale.
Measured: Week 6
Ankle disorders-specific symptoms and functional limitations
Ankle-specific symptoms and functional limitations will be evaluated for soldiers with lateral ankle sprain using the Lower Extremity Functional Scale (LEFS). It is a 20-item questionnaire assessing the impairment of the lower-extremity musculoskeletal system in everyday activities using a 0 (incapacity) to 4 (no difficulty) rating scale.
Measured: Week 12
Ankle disorders-specific symptoms and functional limitations
Ankle-specific symptoms and functional limitations will be evaluated for soldiers with lateral ankle sprain using the Lower Extremity Functional Scale (LEFS). It is a 20-item questionnaire assessing the impairment of the lower-extremity musculoskeletal system in everyday activities using a 0 (incapacity) to 4 (no difficulty) rating scale.
Measured: Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start28 Jan 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A parallel-group randomized-controlled trial with four evaluation sessions over 26 weeks (baseline, week 6 \[mid-intervention\], week 12 \[end of intervention\], week 26) and 16 visits over 12 weeks to the Valcartier Health Centre for the intervention.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Jean-Sébastien Roy, Laval University
- Investigators
- Jean-Sébastien Roy, PT, PhD, Principal investigator, Laval University, Quebec, Qc (Canada)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235152
- Sponsor's protocol ID
- 2021-2039
- Status last verified
- Mar 2022
- First submitted
- 28 Jan 2022
- Last updated
- 2 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dupuis F, Guertin JR, Gagnon R, Larue S, Fredette MA, Hebert LJ, Desmeules F, Perreault K, Roy JS. Is Group-Based Physiotherapy a Cost-Effective Intervention Compared to Usual One-on-One Physiotherapy Care in the Management of Musculoskeletal Disorders in Active Military Personnel? An Economic Evaluation Alongside a Pragmatic Randomized Clinical Trial. J Orthop Sports Phys Ther. 2025 Apr;55(4):295-304. doi: 10.2519/jospt.2025.12888.
PubMed 40145802Dupuis F, Perreault K, Hebert LJ, Perron M, Fredette MA, Desmeules F, Roy JS. Group-based exercice training programs for military members presenting musculoskeletal disorders - protocol for a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2022 Apr 18;23(1):366. doi: 10.1186/s12891-022-05317-6.
PubMed 35436907
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group-based Exercise Training Programs for Military Members Presenting Musculoskeletal Disorders - A Pragmatic Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05235152
- Acronym / sponsor ID
- 2021-2039
- Conditions
- Musculoskeletal Pain, Low Back Pain, Rotator Cuff Tendinitis, Patellofemoral Pain Syndrome, Ankle Sprains
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 28 Jan 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will compare the mid- and long-term effects of group-based training programs with usual individual physiotherapy care for the treatment of musculoskeletal disorders in military. One hundred and twenty soldiers presenting one of the four targeted musculoskeletal disorders (low back pain, rotator cuff related pain, patellofemoral pain syndrome or lateral ankle sprain) will be recruited and randomly assigned to either a 12-weeks group-based training program or 12-weeks usual individual physiotherapy care.
Detailed description
Musculoskeletal disorders are a leading cause of morbidity and the most prevalent source of disability among soldiers. Their high prevalence in armed forces and limited resources have led to problems related to access to physical rehabilitation care. To increase access, supervised group-based exercise programs for the most prevalent musculoskeletal disorders (low back pain, patellofemoral pain, rotator cuff-related shoulder pain or lateral ankle sprain) have been developed at a Canadian Armed forces (CAF) base, but their effectiveness has not been evaluated. The primary objective of this randomized controlled trial is to evaluate the mid- and long-term effects of these group-based training programs on pain severity and functional limitations, in comparison with usual individual physiotherapy care. Secondary objectives include comparing both interventions in terms of health-related quality of life, pain-related fear, and patients' satisfaction.
One hundred and twenty soldiers with a new medical referral for physiotherapy services for one of the four targeted musculoskeletal disorders will be consecutively recruited. They will be randomly assigned to either group-based training program or usual individual physiotherapy care, and will take part in the assigned 12-week intervention. There will be four evaluation sessions over 26 weeks (baseline, week 6, 12 and 26). At each follow-up, functional limitations, pain severity, health-related quality of life and pain-related fears will be assessed. Patients satisfaction with treatment will also be evaluated at the end of the intervention period. A two-way repeated measures ANOVA will be used to analyze and compare the effects of the interventions.
The results of this randomized controlled trial will determine the effectiveness of group-based training programs compared to usual individual physiotherapy care. This new intervention model could represent an efficient, and more pro-active approach to manage a higher number of soldiers with musculoskeletal disorders. It could improve access to physical rehabilitation care and improve the health of soldiers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A parallel-group randomized-controlled trial with four evaluation sessions over 26 weeks (baseline, week 6 [mid-intervention], week 12 [end of intervention], week 26) and 16 visits over 12 weeks to the Valcartier Health Centre for the intervention.
| Arm | Type | Receives |
|---|---|---|
| Usual individual physiotherapy care | Active comparator | Other: Usual individual physiotherapy careParticipants with either low back pain, rotator cuff related pain, patellofemoral pain syndrome or lateral ankle sprain will received usual/individual physiotherapy care over a period of 12-weeks for the treatment of their musculoskeletal conditions if randomized in this group. |
| Group-supervised physiotherapy training programs | Experimental | Other: Group-supervised physiotherapy training programsParticipants with either low back pain, rotator cuff related pain, patellofemoral pain syndrome or lateral ankle sprain will received group-supervised physiotherapy training programs over a period of 12-weeks for the treatment of their musculoskeletal condition if randomized in this group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Aged between 18-60 years
- Present one of the four targeted musculoskeletal disorders:
- Inclusion - 1) Low back pain with or without radiation to the lower limbs, 2) minimal score of 17% on the Modified Oswestry Disability Index (ODI).
- Exclusion - 1) history of surgery or fracture to the spinal column, 2) signs of upper motor neuron lesions (bilateral paresthesia, hyperreflexia or spasticity) or other red flags (e.g. fracture).
- Inclusion - 1) anterior knee pain during running or during at least two activities among: kneeling, squatting, and resisted knee extension 2) score lower than 85/100 on the Knee Outcomes Survey - Activity of Daily Living Scale (KOS- ADLS).
Key exclusion criteria (5 listed)
- Are unavailable to participate in a 12-week intervention;
- Have a diagnosis of rheumatoid, inflammatory, neurological or neurodegenerative disease;
- Received a corticosteroid injection in the previous 6 weeks in the affected region;
- Have had more than 6 months of work restriction for their current musculoskeletal pain;
- Acute conditions (Constant and intense pain [>5/10];Severely limited range of motion [more than 50% in at least 2 directions]; Obvious lateral shift for low back pain or Unable to bear weight [for lateral ankle sprain])
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual individual physiotherapy careUsual and individual physiotherapy care guidelines were developed through a round-table discussion involving experts in musculoskeletal health. From the round-table discussion, the consensus as reflecting best-practices for the rehabilitation of musculoskeletal rehabilitation supported an active exercise rehabilitation approach which includes strengthening and neuromuscular training exercises. Furthermore, the following treatments are considered in addition to active exercises: * Range of motion: active, active-assisted, passive, repeated movements (Mulligan or McKenzie); * Stretching / manual therapy: mobilizations, manipulation, neural mobility, active release therapy; * Individual proprioceptive training. | Other | Usual individual physiotherapy care |
| Group-supervised physiotherapy training programsThree group-supervised physiotherapy training programs (The lumbar, the upper extremity and the lower extremity training programs) were developed for military members with musculoskeletal conditions. They are composed of stations that each include several exercises of varying levels of difficulty. Group size will vary between 5 to 20 participants for one physiotherapist, and each military member performs his/her own exercises. During a typical session, the participant and therapist will choose one exercise to perform per station according to two main criteria: severity of the condition and the ability to perform the exercises optimally. The level of supervision is adapted to the participant's needs and performance. Progression in the programs leads to the execution of exercises that simulate functional and occupational tasks. | Other | Group-supervised physiotherapy training programs |
Primary outcome
Functional limitations
Time frame: Week 26
Pain-related functional limitations will be measured with the Pain Interference subscale of the Brief Pain Inventory - Short Form (BPI). The Pain Interference subscale is recommended for assessment of pain-related functional limitations and includes seven items that measure the level of interference with function caused by pain using 0 (no interference) to 10 (complete interference) rating scales.
25 secondary outcomes
Functional limitations
Time frame: Week 6 (mid-intervention)
Functional limitations
Time frame: Week 12 (end of intervention)
Pain severity
Time frame: Week 6 (mid-intervention)
Pain severity
Time frame: Week 12 (end of intervention)
Pain severity
Time frame: Week 26
Health-related quality of life
Time frame: Week 6 (mid-intervention)
Health-related quality of life
Time frame: Week 12 (end of intervention)
Health-related quality of life
Time frame: Week 26
Pain-related fear
Time frame: Week 6 (mid-intervention)
Pain-related fear
Time frame: Week 12 (end of intervention)
Pain-related fear
Time frame: Week 26
Satisfaction with treatment - PASS
Time frame: Week 12 (end of intervention)
Satisfaction with treatment - Likert Scale
Time frame: Week 12 (end of intervention)
Low back pain-specific symptoms and functional limitations
Time frame: Week 6
Low back pain-specific symptoms and functional limitations
Time frame: Week 12
Low back pain-specific symptoms and functional limitations
Time frame: Week 26
Shoulder disorders-specific symptoms and functional limitations
Time frame: Week 6
Shoulder disorders-specific symptoms and functional limitations
Time frame: Week 12
Shoulder disorders-specific symptoms and functional limitations
Time frame: Week 26
Knee disorders-specific symptoms and functional limitations
Time frame: Week 6
Knee disorders-specific symptoms and functional limitations
Time frame: Week 12
Knee disorders-specific symptoms and functional limitations
Time frame: Week 26
Ankle disorders-specific symptoms and functional limitations
Time frame: Week 6
Ankle disorders-specific symptoms and functional limitations
Time frame: Week 12
Ankle disorders-specific symptoms and functional limitations
Time frame: Week 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 40145802Dupuis F, Guertin JR, Gagnon R, Larue S, Fredette MA, Hebert LJ, Desmeules F, Perreault K, Roy JS. Is Group-Based Physiotherapy a Cost-Effective Intervention Compared to Usual One-on-One Physiotherapy Care in the Management of Musculoskeletal Disorders in Active Military Personnel? An Economic Evaluation Alongside a Pragmatic Randomized Clinical Trial. J Orthop Sports Phys Ther. 2025 Apr;55(4):295-304. doi: 10.2519/jospt.2025.12888.
- Derived from this study: PubMed 35436907Dupuis F, Perreault K, Hebert LJ, Perron M, Fredette MA, Desmeules F, Roy JS. Group-based exercice training programs for military members presenting musculoskeletal disorders - protocol for a pragmatic randomized controlled trial. BMC Musculoskelet Disord. 2022 Apr 18;23(1):366. doi: 10.1186/s12891-022-05317-6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Sébastien Roy, PT, PhD principal investigator
Laval University, Quebec, Qc (Canada)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual individual physiotherapy care and Group-supervised physiotherapy training programs in people with Musculoskeletal Pain and Low Back Pain, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Sébastien Roy, PT, PhD (418-529-9141 ext. 6005, jean-sebastien.roy@rea.ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional limitations (time frame: Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05235152, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2022; AzTrials last refreshed its copy on 30 Oct 2026.