Recruiting

Exercise Training

Sponsor:

Laval University

Code:

NCT05235152

Conditions

Musculoskeletal Pain

Low Back Pain

Rotator Cuff Tendinitis

Patellofemoral Pain Syndrome

Ankle Sprains

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Usual individual physiotherapy care

Group-supervised physiotherapy training programs

Study Details

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.

Conditions

Musculoskeletal Pain

Low Back Pain

Rotator Cuff Tendinitis

Patellofemoral Pain Syndrome

Ankle Sprains

Study ID

NCT05235152

Start date

Jan 28, 2022

Status verified date

Mar, 2022

Completion date

Aug 31, 2023

Anticipated

Primary completion date

Apr 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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 \[for lateral ankle sprain\])

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Usual individual physiotherapy care

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.

experimental: Group-supervised physiotherapy training programs

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.

Interventions

Usual individual physiotherapy care

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 programs

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

  • Functional limitations [ Time Frame: Week 26 ]

Central Contacts and Locations

Central contacts

Locations

Laval University

Recruiting

Québec, Canada, G1V 0A6

Contacts

More Information

Sponsor

Laval University

Last update posted

Mar 2, 2022

Last verified

Mar, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2022-03-02.