Effect of Neuromuscular Electrical Stimulation in Patients With Chronic Low Back Pain

NCT ID: NCT04891692

Last Updated: 2024-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-22
• Study Completion Date: 2024-02-23

Brief Summary

This study evaluates the effect of a 10-week long intervention with the StimaWELL 120MTRS system on multifidus morphology and function in individuals with chronic low back pain. Half the participants will receive muscle therapy at the device's phasic setting, while half will receive muscle therapy at the device's combined setting. This study also evaluates the acute effect of a single treatment with the StimaWELL 120MTRS on multifidus stiffness in individuals with chronic low back pain.

Conditions

Low Back Pain; Paraspinal Muscles

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Phasic Treatment Group

Muscle therapy for the lumbar spine at the StimaWell 120MTRS system's phasic setting. Treatment at 3 kHz, modulation 50 Hz. Supervised 10 week intervention, 2 times a week. Treatment time of 20 minutes for the first 3 weeks, 25 minutes for the second 3 weeks, and 30 minutes for the final 4 weeks. 120MTRS system recalibration every fifth treatment.

Group Type: EXPERIMENTAL

StimaWell 120MTRS system

Intervention Type: DEVICE

Medium-frequency electrotherapy device that delivers current via up to 12 channels. The device also provides heat therapy up to 40°C.

Combined Treatment Group

Muscle therapy for the lumbar spine at the StimaWell 120MTRS system's combined (tonic and phasic) setting. Treatment at 3 kHz, modulation 4 Hz and 50 Hz. Supervised 10 week intervention, 2 times a week. Treatment time of 20 minutes for the first 3 weeks, 25 minutes for the second 3 weeks, and 30 minutes for the final 4 weeks. 120MTRS system recalibration every fifth treatment.

Group Type: EXPERIMENTAL

StimaWell 120MTRS system

Intervention Type: DEVICE

Medium-frequency electrotherapy device that delivers current via up to 12 channels. The device also provides heat therapy up to 40°C.

Interventions

StimaWell 120MTRS system

Medium-frequency electrotherapy device that delivers current via up to 12 channels. The device also provides heat therapy up to 40°C.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Chronic non-specific LBP (>3 months), defined as pain in the region between the lower ribs and gluteal folds, with or without leg pain.
• Aged between 18 to 60 years old.
• English or French speakers
• At least a 4/10 score on an 11-point Numerical Pain Rating Scale (NPRS) for pain intensity.

The score will be the average of current pain, and best and worst pain over the previous week.

• At least a 'moderate' Modified Oswestry Disability Index (ODI) score.
• Able to undergo MRI exam.

Exclusion Criteria

• Currently undergoing or having received physical therapy treatment in the previous month
• Consistent motor control training for the low back and / or consistent weightlifting, power-lifting, bodybuilding, or strongman training in the previous 6 weeks
• History of lumbar surgery
• Presence of positive lumbosacral dermatomes or myotomes
• Presence of disease which could affect the stiffness of muscle tissue (collagen tissue disease, hemiplegia, multiple sclerosis, blood clots)
• Presence of systemic disease (cancer, metabolic syndrome)
• Presence of rheumatoid arthritis
• Presence of spinal stenosis, fracture, infection, or tumor
• Presence of lumbar scoliosis greater than 10 degrees
• Presence of cardiac arrhythmia
• Pregnant and breastfeeding women
• Individuals with epilepsy
• Individuals at risk for serious bleeding
• Individuals with pacemakers or metal implants
• Individuals with aneurysms or heart valve clips
• Individuals with tattoos or piercings in the lumbar spine
• Individuals who have taken prescribed muscle relaxants more than once a week over the past month
• BMI > 30

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mitacs

INDUSTRY

Sponsor Role: collaborator

Concordia University, Montreal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PEFORM Centre

Montreal, Quebec, Canada

Countries

Canada

References

Fortin M, Wolfe D, Dover G, Boily M. The effect of phasic versus combined neuromuscular electrical stimulation using the StimaWELL 120MTRS system on multifidus muscle morphology and function in patients with chronic low back pain: a randomized controlled trial protocol. BMC Musculoskelet Disord. 2022 Jul 1;23(1):627. doi: 10.1186/s12891-022-05578-1.

Reference Type: DERIVED

PMID: 35773711 (View on PubMed)

Other Identifiers

CCER 20-21-07

Identifier Type: -

Identifier Source: org_study_id