Chronic Low-back PainNCT07760142
Multichannel Neuromuscular Electrical Stimulation With Core Exercise for Chronic Low Back Pain
A study testing Core exercise program, StimaWELL 120MTRS - lumbar strengthening program and StimaWELL 120MTRS - muscle relaxation program in people with Chronic Low-back Pain, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Core exercise program, StimaWELL 120MTRS - lumbar strengthening program and StimaWELL 120MTRS - muscle relaxation program
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Aug 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.]
- Physical and cognitive ability to perform the core exercise program.
- Willingness to attend two treatment sessions per week for six weeks (12 sessions total).
- Voluntary participation and provision of written informed consent.
Who cannot join
- 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.
- Pacemaker or other electronic implant; pregnancy; epilepsy; or active cancer.
- Open wound or skin disease in the treatment area.
- Physical therapy for low back pain within the previous month or continuation of another low back pain treatment during the study period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Semiha Atas Timurtas Private Health Professional Services Unit
Şırnak
Semiha Ataş Timurtaş, +90 542 648 16 08
About this study
Official title: Effects of Multichannel Neuromuscular Electrical Stimulation Combined With Core Exercise in Individuals With Chronic Non-Specific Low Back Pain: A Three-Arm Randomized Controlled 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.
Read the detailed description
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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Core exercise program, StimaWELL 120MTRS - lumbar strengthening program, StimaWELL 120MTRS - muscle relaxation program
- Keywords
- neuromuscular electrical stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core exercise programOther
Also called A standardized supervised core exercise program delivered twice weekly for six weeks (12 sessions), identical in all three study arms
Core Exercise + Multichannel NMES Lumbar Strengthening; Core Exercise + Multichannel NMES Muscle Relaxation; Core Exercise Alone
StimaWELL 120MTRS - lumbar strengthening programDevice
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 programDevice
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 group | Role | What they receive |
|---|---|---|
| Core Exercise + Multichannel NMES Lumbar Strengthening | Experimental | 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. Receives: Other: Core exercise program; Device: StimaWELL 120MTRS - lumbar strengthening program |
| Core Exercise + Multichannel NMES Muscle Relaxation | Experimental | 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. Receives: Other: Core exercise program; Device: StimaWELL 120MTRS - muscle relaxation program |
| Core Exercise Alone | Active comparator | 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. Receives: Other: Core exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (week 0) and at the end of the six-week treatment program (week 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start14 Aug 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three-arm, parallel-group randomized controlled trial with 1:1:1 allocation; two groups receive multichannel neuromuscular electrical stimulation plus core exercise and one active comparator group receives core exercise alone.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doç.Dr.Ömer Şevgin, Uskudar University
- Investigators
- Semiha Ataş Timurtaş, Study chair, Üsküdar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07760142
- Sponsor's protocol ID
- Uskudar28
- Other IDs
- Uskudar University
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared publicly
Publications
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.
PubMed 35773711Wolfe D, Dover G, Boily M, Fortin M. The Immediate Effect of a Single Treatment of Neuromuscular Electrical Stimulation with the StimaWELL 120MTRS System on Multifidus Stiffness in Patients with Chronic Low Back Pain. Diagnostics (Basel). 2024 Nov 19;14(22):2594. doi: 10.3390/diagnostics14222594.
PubMed 39594260Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037.
PubMed 33922389Alrwaily M, Schneider M, Sowa G, Timko M, Whitney SL, Delitto A. Stabilization exercises combined with neuromuscular electrical stimulation for patients with chronic low back pain: a randomized controlled trial. Braz J Phys Ther. 2019 Nov-Dec;23(6):506-515. doi: 10.1016/j.bjpt.2018.10.003. Epub 2018 Oct 18.
PubMed 30482602
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multichannel Neuromuscular Electrical Stimulation Combined With Core Exercise in Individuals With Chronic Non-Specific Low Back Pain: A Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07760142
- Acronym / sponsor ID
- Uskudar28
- Conditions
- Chronic Low-back Pain
- Keywords
- neuromuscular electrical stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 14 Aug 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three-arm, parallel-group randomized controlled trial with 1:1:1 allocation; two groups receive multichannel neuromuscular electrical stimulation plus core exercise and one active comparator group receives core exercise alone.
| Arm | Type | Receives |
|---|---|---|
| Core Exercise + Multichannel NMES Lumbar Strengthening | Experimental | Other: Core exercise program, Device: StimaWELL 120MTRS - lumbar strengthening programParticipants 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. |
| Core Exercise + Multichannel NMES Muscle Relaxation | Experimental | Other: Core exercise program, Device: StimaWELL 120MTRS - muscle relaxation programParticipants 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. |
| Core Exercise Alone | Active comparator | Other: Core exercise programParticipants 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.]
- Physical and cognitive ability to perform the core exercise program.
Key exclusion criteria (7 listed)
- 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.
- Pacemaker or other electronic implant; pregnancy; epilepsy; or active cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Core exercise programAlso: A standardized supervised core exercise program delivered twice weekly for six weeks (12 sessions), identical in all three study armsCore Exercise + Multichannel NMES Lumbar Strengthening; Core Exercise + Multichannel NMES Muscle Relaxation; Core Exercise Alone | Other | Core Exercise + Multichannel NMES Lumbar Strengthening, Core Exercise + Multichannel NMES Muscle Relaxation, Core Exercise Alone |
| StimaWELL 120MTRS - lumbar strengthening programMultichannel 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. | Device | Core Exercise + Multichannel NMES Lumbar Strengthening |
| StimaWELL 120MTRS - muscle relaxation programMultichannel 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. | Device | Core Exercise + Multichannel NMES Muscle Relaxation |
Primary outcome
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)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Background: PubMed 35773711Fortin 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.
- Background: PubMed 39594260Wolfe D, Dover G, Boily M, Fortin M. The Immediate Effect of a Single Treatment of Neuromuscular Electrical Stimulation with the StimaWELL 120MTRS System on Multifidus Stiffness in Patients with Chronic Low Back Pain. Diagnostics (Basel). 2024 Nov 19;14(22):2594. doi: 10.3390/diagnostics14222594.
- Background: PubMed 33922389Frizziero A, Pellizzon G, Vittadini F, Bigliardi D, Costantino C. Efficacy of Core Stability in Non-Specific Chronic Low Back Pain. J Funct Morphol Kinesiol. 2021 Apr 22;6(2):37. doi: 10.3390/jfmk6020037.
- Background: PubMed 30482602Alrwaily M, Schneider M, Sowa G, Timko M, Whitney SL, Delitto A. Stabilization exercises combined with neuromuscular electrical stimulation for patients with chronic low back pain: a randomized controlled trial. Braz J Phys Ther. 2019 Nov-Dec;23(6):506-515. doi: 10.1016/j.bjpt.2018.10.003. Epub 2018 Oct 18.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared publicly
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Semiha Ataş Timurtaş study chair
Üsküdar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Core exercise program, StimaWELL 120MTRS - lumbar strengthening program and StimaWELL 120MTRS - muscle relaxation program in people with Chronic Low-back Pain, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ömer şevgin (+905069787535, omer.sevgin@uskudar.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07760142, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.