An interventional study of Core exercise program and StimaWELL 120MTRS - lumbar strengthening program in Chronic Low-back Pain, sponsored by Uskudar University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Uskudar University · Not applicable, Interventional, and Treatment
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.
Design and setting This is a prospective, three-arm, parallel-group, assessor-blinded randomized controlled trial conducted at the Semiha Atas Timurtas Private Health Professional Services Unit in Cizre, Sirnak, Turkey. Institutional permission for the study site has been obtained.
Participants Adults aged 18-55 years with chronic non-specific low back pain lasting at least three months are screened for eligibility. Eligible participants provide written informed consent before study procedures.
Randomization and masking Participants are randomized in a 1:1:1 ratio to one of three treatment groups. Participants and the treating physiotherapist cannot be blinded because of the nature of the interventions. Outcome assessments are performed by a physiotherapist who is unaware of group allocation. [DOLDURULACAK - random sequence generation and allocation concealment method, if available.]
Interventions All groups receive the same standardized core exercise program for six weeks, two sessions per week (12 sessions total). [DOLDURULACAK - exact core exercises, sets/repetitions, session duration, and progression criteria.] Group 1 additionally receives the StimaWELL 120MTRS lumbar strengthening program for 30 minutes at 40 °C during each treatment session.
Group 2 additionally receives the StimaWELL 120MTRS muscle relaxation program for 30 minutes at 40 °C during each treatment session.
Group 3 receives the core exercise program alone and does not receive StimaWELL 120MTRS treatment.
Outcome assessment Assessments are conducted before treatment (baseline/week 0) and after completion of the six-week program (week 6). Low back pain intensity is measured with a 100-mm Visual Analog Scale. Secondary outcomes include the Oswestry Disability Index, Patient-Specific Functional Scale, WHOQOL-BREF Turkish version, and Insomnia Severity Index.
Statistical analysis The planned sample size is 45 participants (15 per group). The sample-size calculation used G*Power 3.1.9 with an effect size of 0.25, alpha of 0.05, and power of 0.80, yielding a minimum required sample of 42; the target was increased to 45 to permit equal allocation. Group, time, and group-by-time interaction will be evaluated using a two-way mixed-design analysis of variance, with statistical significance set at p \< 0.05.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: Core exercise program · Device: StimaWELL 120MTRS - lumbar strengthening program
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.
Other: Core exercise program · Device: StimaWELL 120MTRS - muscle relaxation program
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.
Other: Core exercise program
Core Exercise + Multichannel NMES Lumbar Strengthening; Core Exercise + Multichannel NMES Muscle Relaxation; Core Exercise Alone
Also known as: A standardized supervised core exercise program delivered twice weekly for six weeks (12 sessions), identical in all three study arms
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.
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.
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)
Plan to share: No — Individual participant data are not planned to be shared publicly
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