TENS to relieve myofascial low back pain in adults.

A Prospective, Open-Label, Single-Arm, Self-Controlled Study of Transcutaneous Electrical Nerve Stimulation (TENS) for Adult Low Back Pain

This study will try TENS five times a week for four weeks to see if it reduces pain and improves function in adults with myofascial low back pain.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Xijing Hospital (other)
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT07368920 on ClinicalTrials.gov

What this trial studies

This is a prospective, open-label, single-arm self-controlled trial enrolling 40 adults with myofascial low back pain at Xijing Hospital. All participants will receive transcutaneous electrical nerve stimulation (TENS) five times per week for four consecutive weeks with stimulation set within a safe, tolerable range. Pain and function will be measured at baseline and weekly using the VAS, ODI, JOA, and SF-36, and adverse events will be recorded throughout the study. Patients with structural spinal disease, recent therapies that affect pain assessment, or significant systemic illness are excluded.

Who should consider this trial

Good fit: Adults aged 18–65 with localized myofascial low back pain lasting more than one month, mild baseline pain (VAS < 4), who can comply with frequent in-person sessions are ideal candidates.

Not a fit: Patients whose pain is due to structural spinal conditions (e.g., disc herniation, spinal stenosis), inflammatory or infectious spinal disease, recent physical or medical treatments that affect pain assessment, systemic organ dysfunction, or who cannot attend frequent sessions are less likely to benefit from this protocol.

Why it matters

Potential benefit: If successful, TENS could offer a simple, noninvasive way to reduce pain and improve daily function and quality of life for adults with myofascial low back pain.

How similar studies have performed: Previous TENS studies for low back pain have reported modest short-term pain relief in some patients but overall results are mixed and long-term benefit is uncertain.

Eligibility criteria

Inclusion Criteria:

1. Adults aged 18-65 years
2. Diagnosis consistent with myofascial low back pain (localized low back pain with a palpable taut band; referred pain and/or sensory changes near a specific trigger point; an identifiable tender spot within the taut band; mild muscle weakness and/or some limitation of joint range of motion)
3. Mild pain intensity at baseline (VAS \< 4 on a 0-10 scale)
4. Symptom duration \> 1 month
5. Able to understand the study procedures and demonstrate good compliance/cooperation
6. Written informed consent provided

Exclusion Criteria:

1. Low back pain due to other causes, including but not limited to lumbar disc herniation, lumbar spinal stenosis, ankylosing spondylitis, spinal tumor, spinal tuberculosis, or spinal infection
2. Received physical therapy, interventional procedures, or medication treatment within 4 weeks prior to enrollment that may affect pain or function assessment
3. Systemic disease or organ dysfunction
4. Skin/soft tissue breakdown or infection at/near the planned treatment area
5. Use of sedative medications or opioid analgesics within 6 months prior to enrollment, or currently receiving other treatments that may affect study outcomes
6. Severe psychiatric disorder or inability to cooperate with study procedures
7. Pregnant or breastfeeding women

Where this trial is running

Xi'an, Shaanxi

• Xjing hospital — Xi'an, Shaanxi, China (RECRUITING)

Study contacts

• Study coordinator: Bo Gao MD, PhD

Conditions: Low Back Pain, Paraspinal Muscles, CLBP - Chronic Low Back Pain, Low back pain, Transcutaneous electrical stimulation, Self-controlled clinical trial