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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in low back pain intensity (100-mm Visual Analog Scale)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and treating physiotherapist are not blinded; the physiotherapist performing outcome assessments is blinded to group allocation.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 >=
- •[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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Core exercise program (Other)
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.
干预措施: Core exercise program (Other)
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.
干预措施: StimaWELL 120MTRS - lumbar strengthening program (Device)
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.
干预措施: Core exercise program (Other)
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.
干预措施: StimaWELL 120MTRS - muscle relaxation program (Device)
结局指标
主要结局
Change in low back pain intensity (100-mm Visual Analog Scale)
时间窗: 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.
次要结局
未报告次要终点
研究者
Doç.Dr.Ömer Şevgin
Associate Professor
Uskudar University