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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorUskudar University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18 to 55 years.

Chronic non-specific low back pain lasting at least three months.

Low back pain not attributable to a specific trauma, infection, tumor, fracture, rheumatologic disease, or serious neurological disorder.

Pain intensity meeting the protocol threshold stated as VAS >=3. [TEYIT - because the outcome VAS is a 100-mm scale, clarify whether the intended eligibility threshold is >=30 mm (equivalent to 3/10) rather than >=3 mm.]

Disqualifiers

Age younger than 18 years or older than 55 years.

Low back pain due to disc herniation, spinal stenosis, fracture, tumor, infection, or inflammatory disease.

Nerve root involvement, marked sensory loss, or muscle weakness.

Previous lumbar spine surgery.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Core exercise program

    Other intervention

    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.

Treatment groups

45 Participants
are divided into 3 treatment groups
Group A: Core Exercise + Multichannel NMES Lumbar StrengtheningExperimental treatment 2 interventions
Group B: Core Exercise + Multichannel NMES Muscle RelaxationExperimental treatment 2 interventions
Group C: Core Exercise AloneActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in low back pain intensity (100-mm Visual Analog Scale)

Low back pain intensity is assessed using a 100-mm horizontal Visual Analog Scale. Participants mark the point that best represents their average low back pain during the previous seven days, anchored by 0 mm (no pain) and 100 mm (unbearable pain). The distance from the 0-mm anchor to the mark is measured in millimeters. Higher values indicate greater pain intensity.

Time frame
Baseline (week 0) and at the end of the six-week treatment program (week 6)

Secondary outcomes

Other outcomes

Sponsors and contacts

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