Transcutaneous Electrical Nerve Stimulation (TENS) for the Treatment of Low Back Pain (LBP) in Adults
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorXijing Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Transcutaneous Electrical Nerve Stimulation (TENS)
DeviceTENS 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Transcutaneous Electrical Stimulation (TENS)）Experimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline (Day 0, pre-intervention), Week 1, Week2, Week3 and Week 4 after treatment initiation (end of treatment at Week 4).Secondary outcomes
1
Disability Severity Assessed by Oswestry Disability Index (ODI) Score
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.
Time frame
Baseline (Day 0, pre-intervention), Week 1, Week2, Week3 and Week 4 after treatment initiation (end of treatment at Week 4).2
Lumbar Functional Status Assessed by Japanese Orthopaedic Association (JOA) Score
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.
Time frame
Baseline (Day 0, pre-intervention), Week 1, Week2, Week3 and Week 4 after treatment initiation (end of treatment at Week 4).3
Health-Related Quality of Life Assessed by SF-36 Total Score
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.
Time frame
Baseline (Day 0, pre-intervention), Week 1, Week2, Week3 and Week 4 after treatment initiation (end of treatment at Week 4).4
Lumbar Paraspinal Muscle Cross-Sectional Area Assessed by MRI
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.
Time frame
Baseline (Day 0, pre-intervention) and Week 4 after the start of treatmentOther outcomes
1
Incidence of Adverse Events During Treatment
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.
Time frame
Within 4 weeks after the start of treatment (during the 4-week treatment period).Sponsors and contacts
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Source ClinicalTrials.gov