Clinical trial NCT05235152: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Musculoskeletal Pain
Low Back Pain
Rotator Cuff Tendinitis
Patellofemoral Pain Syndrome
Ankle Sprains
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-02-11
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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:

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 \[for lateral ankle sprain\])

Primary outcomes:
measure: Functional limitations
timeFrame: Week 26
Secondary outcomes:
measure: Functional limitations
timeFrame: Week 6 (mid-intervention)
measure: Functional limitations
timeFrame: Week 12 (end of intervention)
measure: Pain severity
timeFrame: Week 6 (mid-intervention)
measure: Pain severity
timeFrame: Week 12 (end of intervention)
measure: Pain severity
timeFrame: Week 26
measure: Health-related quality of life
timeFrame: Week 6 (mid-intervention)
measure: Health-related quality of life
timeFrame: Week 12 (end of intervention)
measure: Health-related quality of life
timeFrame: Week 26
measure: Pain-related fear
timeFrame: Week 6 (mid-intervention)
measure: Pain-related fear
timeFrame: Week 12 (end of intervention)
measure: Pain-related fear
timeFrame: Week 26
measure: Satisfaction with treatment - PASS
timeFrame: Week 12 (end of intervention)
measure: Satisfaction with treatment - Likert Scale
timeFrame: Week 12 (end of intervention)
measure: Low back pain-specific symptoms and functional limitations
timeFrame: Week 6
measure: Low back pain-specific symptoms and functional limitations
timeFrame: Week 12
measure: Low back pain-specific symptoms and functional limitations
timeFrame: Week 26
measure: Shoulder disorders-specific symptoms and functional limitations
timeFrame: Week 6
measure: Shoulder disorders-specific symptoms and functional limitations
timeFrame: Week 12
measure: Shoulder disorders-specific symptoms and functional limitations
timeFrame: Week 26
measure: Knee disorders-specific symptoms and functional limitations
timeFrame: Week 6
measure: Knee disorders-specific symptoms and functional limitations
timeFrame: Week 12
measure: Knee disorders-specific symptoms and functional limitations
timeFrame: Week 26
measure: Ankle disorders-specific symptoms and functional limitations
timeFrame: Week 6
measure: Ankle disorders-specific symptoms and functional limitations
timeFrame: Week 12
measure: Ankle disorders-specific symptoms and functional limitations
timeFrame: Week 26
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Laval University
Study officials:
affiliation: Laval University, Quebec, Qc (Canada)
name: Jean-Sébastien Roy, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.