Multichannel Neuromuscular Electrical Stimulation With Core Exercise for Chronic Low Back Pain

Sponsor
Uskudar University
Study ID
NCT07760142
Status
Recruiting
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Conditions

  • Chronic Low-back Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Not accepted

Interventions

  • Core exercise program — OTHER
    Core Exercise + Multichannel NMES Lumbar Strengthening; Core Exercise + Multichannel NMES Muscle Relaxation; Core Exercise Alone
  • StimaWELL 120MTRS - lumbar strengthening program — DEVICE
    Multichannel neuromuscular electrical stimulation using the StimaWELL 120MTRS lumbar strengthening program, applied for 30 minutes at 40 °C, twice weekly for six weeks (12 sessions), in addition to the core exercise program.
  • StimaWELL 120MTRS - muscle relaxation program — DEVICE
    Multichannel neuromuscular electrical stimulation using the StimaWELL 120MTRS muscle relaxation program, applied for 30 minutes at 40 °C, twice weekly for six weeks (12 sessions), in addition to the core exercise program.

Study Details

Chronic non-specific low back pain is a common musculoskeletal condition that can adversely affect daily activities, functional capacity, sleep, and quality of life. Exercise therapy is a key component of conservative management, and core exercises are used to improve trunk control and the coordinated function of the abdominal, lumbar, and pelvic musculature. Neuromuscular electrical stimulation may be added to exercise to facilitate muscle activation and support pain management; however, the additional clinical benefit of different multichannel stimulation programs remains uncertain. This three-arm randomized controlled trial evaluates the effects of two multichannel neuromuscular electrical stimulation programs added to a standardized core exercise program in adults with chronic non-specific low back pain. Forty-five participants are allocated in a 1:1:1 ratio to (1) core exercise plus a lumbar strengthening stimulation program, (2) core exercise plus a muscle relaxation stimulation program, or (3) core exercise alone. Treatment is delivered twice weekly for six weeks (12 sessions). In the two stimulation groups, StimaWELL 120MTRS therapy is applied for 30 minutes at 40 °C. Outcomes are assessed at baseline and at week 6. The primary outcome is low back pain intensity measured with a 100-mm Visual Analog Scale. Secondary outcomes are disability, patient-specific functional status, quality of life, and insomnia severity.

Key Dates

First listed
Aug 12, 2026
Start date
Aug 14, 2026
Status verified
Aug 2026
Primary completion
Dec 1, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
45 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Core Exercise + Multichannel NMES Lumbar Strengthening
    Participants receive the standardized core exercise program plus the StimaWELL 120MTRS lumbar strengthening program. Treatment is delivered twice weekly for six weeks (12 sessions). The device program is applied for 30 minutes at 40 °C during each treatment session.
  • Experimental: Core Exercise + Multichannel NMES Muscle Relaxation
    Participants receive the standardized core exercise program plus the StimaWELL 120MTRS muscle relaxation program. Treatment is delivered twice weekly for six weeks (12 sessions). The device program is applied for 30 minutes at 40 °C during each treatment session.
  • Active Comparator: Core Exercise Alone
    Participants receive only the standardized core exercise program, identical to the core exercise program used in the other two groups, twice weekly for six weeks (12 sessions). No StimaWELL 120MTRS treatment is administered.

Primary Outcome Measure

Change in low back pain intensity (100-mm Visual Analog Scale) [ Time Frame: Baseline (week 0) and at the end of the six-week treatment program (week 6) ]

Central Contacts

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