Low Back PainNCT07368920
Transcutaneous Electrical Nerve Stimulation (TENS) for the Treatment of Low Back Pain (LBP) in Adults
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Low Back Pain and Paraspinal Muscles, run by Xijing Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain, Paraspinal Muscles, CLBP - Chronic Low Back Pain
- What is being tested?
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Transcutaneous Electrical Nerve Stimulation (TENS)
- Keywords
- Low back pain, Transcutaneous electrical stimulation, Self-controlled clinical trial
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline (Day 0, pre-intervention) and Week 4 after the start of treatment
Lumbar Paraspinal Muscle Fat Infiltration Rate Assessed by MRI
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.
Measured: Baseline (Day 0, pre-intervention) and Week 4 after the start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start1 Feb 2026
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Gao, MD, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368920
- Sponsor's protocol ID
- KY20252517
- Status last verified
- Mar 2026
- First submitted
- 20 Jan 2026
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Single-Arm, Self-Controlled Study of Transcutaneous Electrical Nerve Stimulation (TENS) for Adult Low Back Pain
- ClinicalTrials.gov ID
- NCT07368920
- Acronym / sponsor ID
- KY20252517
- Keywords
- Low back pain, Transcutaneous electrical stimulation, Self-controlled clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 27 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Electrical Stimulation (TENS)） | Experimental | Device: Transcutaneous Electrical Nerve 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Transcutaneous Electrical Stimulation (TENS)） |
Primary outcome
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.
5 secondary outcomes
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).
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).
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).
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 Paraspinal Muscle Fat Infiltration Rate Assessed by MRI
Time frame: Baseline (Day 0, pre-intervention) and Week 4 after the start of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Electrical Nerve Stimulation (TENS) in people with Low Back Pain and Paraspinal Muscles, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Gao MD, PhD (029-84775507, gaobofmmu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.