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

March 19, 2026 updated by: Bo Gao, MD, Xijing Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xjing hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcutaneous Electrical Stimulation (TENS)）
All enrolled participants in this arm will receive transcutaneous electrical nerve stimulation (TENS) therapy 5 times per week for 4 consecutive weeks. Treatment will be delivered according to a standardized protocol, with stimulation intensity adjusted within a safe range based on individual tolerance. Outcomes will be assessed at baseline and weekly during the 4-week treatment period, and adverse events will be recorded.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity Assessed by Visual Analog Scale (VAS) Score
Time Frame: Baseline (Day 0, pre-intervention), Week 1, Week2, Week3 and Week 4 after treatment initiation (end of treatment at Week 4).
Pain intensity will be assessed using the Visual Analog Scale (VAS), a validated tool with a score range from 0 to 10 points. A score of 0 represents no pain, and a score of 10 represents the most severe pain imaginable. This outcome measure evaluates changes in pain intensity in adults with chronic low back pain (cLBP) following treatment with oral sodium aescinate tablets.
Baseline (Day 0, pre-intervention), Week 1, Week2, Week3 and Week 4 after treatment initiation (end of treatment at Week 4).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disability Severity Assessed by Oswestry Disability Index (ODI) Score
Time Frame: Baseline (Day 0, pre-intervention), Week 1, Week2, Week3 and Week 4 after treatment initiation (end of treatment at Week 4).
Disability related to low back pain will be assessed using the Oswestry Disability Index (ODI), a widely used questionnaire with a total score range of 0 to 50 points. Higher scores indicate greater disability in activities of daily living. This outcome measure evaluates changes in functional disability in cLBP patients after treatment.
Baseline (Day 0, pre-intervention), Week 1, Week2, Week3 and Week 4 after treatment initiation (end of treatment at Week 4).
Lumbar Functional Status Assessed by Japanese Orthopaedic Association (JOA) Score
Time Frame: Baseline (Day 0, pre-intervention), Week 1, Week2, Week3 and Week 4 after treatment initiation (end of treatment at Week 4).
Lumbar spine function will be evaluated using the Japanese Orthopaedic Association (JOA) score, which ranges from 0 to 29 points. Lower scores indicate more severe functional impairment. This outcome measure assesses changes in lumbar spine function following treatment.
Baseline (Day 0, pre-intervention), Week 1, Week2, Week3 and Week 4 after treatment initiation (end of treatment at Week 4).
Health-Related Quality of Life Assessed by SF-36 Total Score
Time Frame: Baseline (Day 0, pre-intervention), Week 1, Week2, Week3 and Week 4 after treatment initiation (end of treatment at Week 4).
Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). The total score ranges from 0 to 100 points, with higher scores indicating better overall health status. This outcome measure evaluates changes in overall quality of life in cLBP patients following treatment.
Baseline (Day 0, pre-intervention), Week 1, Week2, Week3 and Week 4 after treatment initiation (end of treatment at Week 4).
Lumbar Paraspinal Muscle Cross-Sectional Area Assessed by MRI
Time Frame: Baseline (Day 0, pre-intervention) and Week 4 after the start of treatment
Lumbar MRI will be used to measure the cross-sectional area of paraspinal muscles as an objective indicator of muscle mass. This outcome measure evaluates changes in paraspinal muscle size following treatment with sodium aescinate tablets.
Baseline (Day 0, pre-intervention) and Week 4 after the start of treatment
Lumbar Paraspinal Muscle Fat Infiltration Rate Assessed by MRI
Time Frame: Baseline (Day 0, pre-intervention) and Week 4 after the start of treatment
Lumbar MRI will be used to assess the fat infiltration rate of paraspinal muscles as an indicator of muscle quality. This outcome measure evaluates changes in paraspinal muscle composition following treatment.
Baseline (Day 0, pre-intervention) and Week 4 after the start of treatment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Adverse Events During Treatment
Time Frame: Within 4 weeks after the start of treatment (during the 4-week treatment period).
All adverse events (AEs) occurring during the 4-week TENS treatment period will be recorded. For each AE, the event type, severity, onset and duration, action taken (if any), outcome, and the investigator-assessed relationship to the TENS intervention/device will be documented to evaluate safety and tolerability.
Within 4 weeks after the start of treatment (during the 4-week treatment period).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

January 20, 2026

First Submitted That Met QC Criteria

January 20, 2026

First Posted (Actual)

January 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20252517

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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