RecruitingNot ApplicableNCT07368920

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

Sponsor

Xijing Hospital

Enrollment

40 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

Low Back Pain CLBP - Chronic Low Back Pain Paraspinal Muscles

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

Adults aged 18-65 years
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)
Mild pain intensity at baseline (VAS \< 4 on a 0-10 scale)
Symptom duration \> 1 month
Able to understand the study procedures and demonstrate good compliance/cooperation
Written informed consent provided

Exclusion Criteria7

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
Received physical therapy, interventional procedures, or medication treatment within 4 weeks prior to enrollment that may affect pain or function assessment
Systemic disease or organ dysfunction
Skin/soft tissue breakdown or infection at/near the planned treatment area
Use of sedative medications or opioid analgesics within 6 months prior to enrollment, or currently receiving other treatments that may affect study outcomes
Severe psychiatric disorder or inability to cooperate with study procedures
Pregnant or breastfeeding women

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Interventions

DEVICETranscutaneous 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.