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Group-based Exercise Training Programs for Military Members With Musculoskeletal Conditions

Primary Purpose

Musculoskeletal Pain, Low Back Pain, Rotator Cuff Tendinitis

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Usual individual physiotherapy care
Group-supervised physiotherapy training programs
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Musculoskeletal Pain

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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:

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).

Exclusion Criteria for all diagnosis:

  1. Are unavailable to participate in a 12-week intervention;
  2. Have a diagnosis of rheumatoid, inflammatory, neurological or neurodegenerative disease;
  3. Received a corticosteroid injection in the previous 6 weeks in the affected region;
  4. Have had more than 6 months of work restriction for their current musculoskeletal pain;
  5. 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])

Sites / Locations

  • Laval UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual individual physiotherapy care

Group-supervised physiotherapy training programs

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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'').
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 28, 2022
Last Updated
March 1, 2022
Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05235152
Brief Title
Group-based Exercise Training Programs for Military Members With Musculoskeletal Conditions
Official Title
Group-based Exercise Training Programs for Military Members Presenting Musculoskeletal Disorders - A Pragmatic Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 28, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
August 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Pain, Low Back Pain, Rotator Cuff Tendinitis, Patellofemoral Pain Syndrome, Ankle Sprains

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
The research assistant and treating therapist will be blinded to baseline evaluation results. Given that for this type of intervention it is impossible to blind the treating physiotherapists and participants, only the investigator, evaluator and statistician will be blinded.
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual individual physiotherapy care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group-supervised physiotherapy training programs
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Usual individual physiotherapy care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Group-supervised physiotherapy training programs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functional limitations
Description
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.
Time Frame
Week 26
Secondary Outcome Measure Information:
Title
Functional limitations
Description
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.
Time Frame
Week 6 (mid-intervention)
Title
Functional limitations
Description
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.
Time Frame
Week 12 (end of intervention)
Title
Pain severity
Description
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.
Time Frame
Week 6 (mid-intervention)
Title
Pain severity
Description
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.
Time Frame
Week 12 (end of intervention)
Title
Pain severity
Description
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.
Time Frame
Week 26
Title
Health-related quality of life
Description
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.
Time Frame
Week 6 (mid-intervention)
Title
Health-related quality of life
Description
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.
Time Frame
Week 12 (end of intervention)
Title
Health-related quality of life
Description
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.
Time Frame
Week 26
Title
Pain-related fear
Description
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.
Time Frame
Week 6 (mid-intervention)
Title
Pain-related fear
Description
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.
Time Frame
Week 12 (end of intervention)
Title
Pain-related fear
Description
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.
Time Frame
Week 26
Title
Satisfaction with treatment - PASS
Description
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).
Time Frame
Week 12 (end of intervention)
Title
Satisfaction with treatment - Likert Scale
Description
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'').
Time Frame
Week 12 (end of intervention)
Title
Low back pain-specific symptoms and functional limitations
Description
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.
Time Frame
Week 6
Title
Low back pain-specific symptoms and functional limitations
Description
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.
Time Frame
Week 12
Title
Low back pain-specific symptoms and functional limitations
Description
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.
Time Frame
Week 26
Title
Shoulder disorders-specific symptoms and functional limitations
Description
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.
Time Frame
Week 6
Title
Shoulder disorders-specific symptoms and functional limitations
Description
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.
Time Frame
Week 12
Title
Shoulder disorders-specific symptoms and functional limitations
Description
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.
Time Frame
Week 26
Title
Knee disorders-specific symptoms and functional limitations
Description
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.
Time Frame
Week 6
Title
Knee disorders-specific symptoms and functional limitations
Description
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.
Time Frame
Week 12
Title
Knee disorders-specific symptoms and functional limitations
Description
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.
Time Frame
Week 26
Title
Ankle disorders-specific symptoms and functional limitations
Description
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.
Time Frame
Week 6
Title
Ankle disorders-specific symptoms and functional limitations
Description
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.
Time Frame
Week 12
Title
Ankle disorders-specific symptoms and functional limitations
Description
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.
Time Frame
Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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: 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). Exclusion Criteria for all diagnosis: 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])
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-Sébastien Roy, PT, PhD
Phone
418-529-9141
Ext
6005
Email
jean-sebastien.roy@rea.ulaval.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Frédérique Dupuis, PT
Phone
418-529-9141
Ext
6127
Email
frederique.dupuis.1@ulaval.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Sébastien Roy, PT, PhD
Organizational Affiliation
Laval University, Quebec, Qc (Canada)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laval University
City
Québec
ZIP/Postal Code
G1V 0A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Sébastien Roy, PhD
Phone
(418) 529 9141
Ext
6005
Email
Jean-Sebastien.Roy@fmed.ulaval.ca
First Name & Middle Initial & Last Name & Degree
Frédérique Dupuis, PhD Student
Phone
5819997113
Email
frederique.dupuis.1@ulaval.ca
First Name & Middle Initial & Last Name & Degree
Kadija Perreault, PhD
First Name & Middle Initial & Last Name & Degree
Luc.J Hébert, PhD
First Name & Middle Initial & Last Name & Degree
Marc Perron, M.Sc
First Name & Middle Initial & Last Name & Degree
Anny Fredette, M.Sc
First Name & Middle Initial & Last Name & Degree
François Desmeules, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35436907
Citation
Dupuis 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.
Results Reference
derived

Learn more about this trial

Group-based Exercise Training Programs for Military Members With Musculoskeletal Conditions

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