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

NCT07368920 | Recruiting

• 1 other identifier: KY20252517
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Low back pain; Transcutaneous electrical stimulation; Self-controlled clinical trial

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Assessed by Visual Analog Scale (VAS) Score

  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 Outcomes (5)

• Disability Severity Assessed by Oswestry Disability Index (ODI) Score

  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

  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

  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

  Baseline (Day 0, pre-intervention) and Week 4 after the start of treatment

• Lumbar Paraspinal Muscle Fat Infiltration Rate Assessed by MRI

  Baseline (Day 0, pre-intervention) and Week 4 after the start of treatment

Other Outcomes (1)

• Incidence of Adverse Events During Treatment

  Within 4 weeks after the start of treatment (during the 4-week treatment period).

Study Arms (1)

Transcutaneous Electrical Stimulation (TENS)）

EXPERIMENTAL

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)

Interventions

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

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.

Transcutaneous Electrical Stimulation (TENS)）

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xjing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Bo Gao MD, PhD

CONTACT

029-84775507; gaobofmmu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open-label study with no masking. Participants, care providers, investigators, and outcome assessors are all aware of the intervention assignment, as all participants receive the same TENS intervention.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: This is a prospective, open-label, single-arm, self-controlled study. All enrolled participants will receive transcutaneous electrical stimulation (TENS) with a fixed treatment course of 5 sessions per week for 4 consecutive weeks, with stimulation parameters adjusted within a safe range based on individual tolerance. There is no parallel comparator group; each participant serves as their own control. Outcomes will be assessed at baseline and at Weeks 1, 2, 3, and 4 after treatment initiation, and adverse events/complications will be recorded throughout the study period.

Study Record Dates

• First Submitted: January 20, 2026
• First Posted: January 27, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)