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

NCT07760142 | Not Yet Recruiting

• 2 other identifiers: Uskudar28Uskudar University
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Low-back Pain

Keywords

neuromuscular electrical stimulation

Outcome Measures

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.

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

Study Arms (3)

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.

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.

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.

Other: Core exercise program

Interventions

Core exercise program OTHER

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

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.

Core Exercise + Multichannel NMES Lumbar Strengthening

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.

Core Exercise + Multichannel NMES Muscle Relaxation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Semiha Atas Timurtas Private Health Professional Services Unit

Şırnak, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 35773711 BACKGROUND

• Wolfe 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.

  PMID: 39594260 BACKGROUND

• Frizziero 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.

  PMID: 33922389 BACKGROUND

• Alrwaily 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.

  PMID: 30482602 BACKGROUND

Study Officials

• Semiha Ataş Timurtaş

  Üsküdar University

  STUDY CHAIR

Central Study Contacts

ömer şevgin

CONTACT

+905069787535; omer.sevgin@uskudar.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and treating physiotherapist are not blinded; the physiotherapist performing outcome assessments is blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 12, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)