NCT07368920

Transcutaneous Electrical Nerve Stimulation (TENS) for the Treatment of Low Back Pain (LBP) in Adults

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to assess the effects and safety of transcutaneous electrical nerve stimulation (TENS) in adults with myofascial low back pain. Eligible participants will receive TENS treatment 5 times per week for 4 weeks. Pain intensity and functional outcomes will be assessed at baseline and weekly during the 4-week treatment period, and adverse events will be recorded.

Detailed description

This study is a prospective, open-label, single-arm, self-controlled clinical trial conducted at the Department of Orthopaedics, Xijing Hospital. A total of 40 adult participants with myofascial low back pain will be recruited according to predefined inclusion and exclusion criteria and enrolled after providing written informed consent. All enrolled participants will receive transcutaneous electrical stimulation (TENS) therapy with a treatment schedule of 5 sessions per week for 4 consecutive weeks. The stimulation parameters and single-session duration will be set within a safe range and may be adjusted according to individual tolerance. Outcome assessments will be performed at baseline (Day 0, before intervention) and at Weeks 1, 2, 3, and 4 after treatment initiation. Pain intensity will be evaluated using the Visual Analog Scale (VAS; 0-10). Secondary outcomes include the Oswestry Disability Index (ODI), Japanese Orthopaedic Association (JOA) score, and the Short Form-36 (SF-36) to assess functional status and quality of life. Safety will be monitored throughout the study, with adverse events and complications recorded during the study period and follow-up.

Conditions

• Low Back Pain
• Paraspinal Muscles
• CLBP - Chronic Low Back Pain

Interventions

Type	Name	Description
DEVICE	Transcutaneous Electrical Nerve Stimulation (TENS)	TENS will be delivered via surface electrodes placed bilaterally around the area of maximal low back pain. Each session will last 20-30 minutes, administered 5 times per week for 4 weeks. Stimulation intensity will be titrated to a strong but comfortable sensation without pain, and parameters may be adjusted based on participant tolerance. Safety will be monitored throughout treatment and follow-up.

Timeline

• Start date: 2026-02-01
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2026-01-27
• Last updated: 2026-03-20

Locations

1 site across 1 country: China