Strengthening and targeted rehabilitation in patients with chronic low back pain

Strengthening and Targeted Rehabilitation for Optimal Neuromuscular Gains for Chronic BACK Pain (STRONG-BACK): a randomized controlled trial in participants with primary nociceptive pain drivers

Registry ID
ISRCTN14864451
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
Concordia University
Enrollment
106
Start date
2025-12-01
Completion date
2028-08-01
Last update
2026-08-17

Conditions

Summary

Nociceptive chronic low back pain

Detailed description

Randomization: Participants will be randomized into treatment groups using RedCap software. A statistician outside of the research team will generate the randomization sequence and upload it on RedCap. Randomization sequence will be blocked and stratified by the score obtained on the LSIQ questionnaire (high >9, and low < 9). Randomization will occur at the time of the first treatment sessions by the treating therapists, who will log into RedCap and randomize participants, ensuring allocation concealment. Blinding: This trial will be randomized with concealed allocation and assessor blinding. True blinding of therapists and patients is not possible within an exercise trial. However, the therapists and participants will be blinded to the results of the LSIQ. Arm 1 - Experimental: Motor control + isolated lumbar extension exercise (MC+ILEX). Targeted motor control and isolated lumbar extensor strengthening exercises. Supervised 16-week program, 3 times a week. This experimental intervention group is called motor control as it uses principles of motor learning such as segmentation, simplification, and task-specific practice to retrain control of trunk muscles activation, alignment and movement. The intervention is based on assessment of the individual patient’s motor control impairments and the patient’s individual treatment goals (set collaboratively with the therapist). MC will be combined with ILEX exercise to maximize the stimulus and induce adaption of the lumbar extensors. ILEX training will be performed on the MedX Lumbar Extension Machine (MedX, Ocala, FL). Each training session (60 minutes) will be individually supervised by certified athletic therapists. The intervention will last 16 weeks and will take place in the Concordia University School of Health. Arm 2 - Experimental: Free-weight resistance training Free-weight resistance training program to address impairments in muscle strength, muscle quality and endurance. Supervised 16-week program, 3 times a

Interventions

Inclusion criteria

1. Chronic non-specific LBP (>3 months) defined based on the NIH task force recommendations 2. Between 18 and 60 years of age 3. Speak English or French (to allow response to questionnaires and communication with therapist) 4. Present with predominant nociceptive chronic LBP, namely, score Category A for nociceptive drivers, Category 0 for nervous system dysfunction (absence of neurological involvement), Category 0 for comorbidity drivers (absence of comorbidity), and Category 0 for cognitive-emotional factors and Category 0 or A contextual for drivers on the Pain and Disability Drivers Management (PDDM).

Exclusion criteria

1. Previous spinal surgery or vertebral fractures 2. Radiculopathy 3. Other major lumbar spine structural abnormalities (e.g., spondylolysis, spondylolisthesis, or lumbar scoliosis >10°) 4. Health conditions that would prevent active participation in exercise (e.g. systemic inflammation) 5. Institutional contraindications for undergoing an MRI exam (e.g., pregnancy)

Locations

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