Lumbar Disc HerniationNCT06611332
Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy
A study testing Electroacupuncture in people with Lumbar Disc Herniation and Radiculopathy Lumbar, run by Jiangxi University of Traditional Chinese Medicine at 1 site in China.
Trial summary
Lumbar disc herniation with radiculopathy (LDHR) is the local displacement of the intervertebral disc and its contents beyond the edge of the normal intervertebral disc space, resulting in pain, weakness or numbness in the muscle or dermatomal distribution area. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Lumbar Disc Herniation, Radiculopathy Lumbar
- What is being tested?
- Electroacupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to 25 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged from 18 to 70 years old.
- With intervertebral disc protrusion confirmed by a MRI or CT, accompanied by radicular pain in the lower extremities.
- With a NRS score ≥ 4 points for both low back pain and leg pain, and the pain lasts for at least 3 months;
- Voluntarily participating the trial and signing the informed consent form.
Who cannot join
- Previous surgical treatment of the spine.
- Received any physical therapy for lumbar disc herniation within the recent 3 months.
- Complicated with diseases that can cause low back and leg pain.
- Symptomatic foraminal stenosis caused by severe degenerative diseases, accompanied by severe nerve injuries.
- Previous severe mental illness, organ failure, or malignant tumor.
- Planned spinal surgery or other major surgeries within the next 3 months.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
China1 site
The Affiliated Hospital of Jiangxi University of Chinese Medicine
Jiangxi, Nanchang, 330006
Xu Zhou Professor, M.D., +86-0791-86363831, 88299077@qq.com
About this study
Official title: Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy: a Randomized Controlled Trial
Lumbar disc herniation with radiculopathy (LDHR) is the local displacement of the intervertebral disc and its contents beyond the edge of the normal intervertebral disc space, resulting in pain, weakness or numbness in the muscle or dermatomal distribution area. Electroacupuncture is based on obtaining the needling sensation manually and applying electrical stimulation of different frequencies and intensities, aiming to enhance the intensity of acupoint stimulation to improve the effect. As a kind of acupoint stimulation therapy, electroacupuncture has shown analgesic effects in animal experiments. However, at present, the clinical evidence of electroacupuncture applied in the treatment of LDHR is still insufficient. Therefore, this randomized, single-blind, sham electroacupuncture controlled trial aims to evaluate the efficacy and safety of electroacupuncture as a treatment for LDHR.
- Conditions
- Lumbar Disc Herniation, Radiculopathy Lumbar
- Being tested
- Electroacupuncture, Sham electroacupuncture
- Keywords
- electroacupuncture, radiculopathy, sham control, randomized controlled trial, lumbar disc herniation
- Medical subject headings
- Intervertebral Disc Displacement, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroacupunctureOther
The main acupoints selected for the electroacupuncture group are bilateral BL23, bilateral BL25, bilateral GB30, bilateral LR11, bilateral LR8, GV4, GV3, and the affected BL40, and the secondary acupoints selected are bilateral BL54, the affected side BL57 and the affected side BL60.The treatment will be administered once every other day for 30 minutes each time, lasting for 8 consecutive weeks, totaling 24 sessions.
Sham electroacupunctureOther
In the sham electroacupuncture group, the acupoints will be at a position 2 cm lateral to the correct acupoints horizontally. The dosage and treatment course are the same as those in the electroacupuncture group.
| Study group | Role | What they receive |
|---|---|---|
| Electroacupuncture | Experimental | Not described Receives: Other: Electroacupuncture |
| Sham electroacupuncture | Sham comparator | Not described Receives: Other: Sham electroacupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of responders
Definition of a response: a reduction of at least 2 points in the score of the Numerical Rating Scale for both low back pain and leg pain.
Measured: Weeks 8 and 24
Secondary outcomes (13)
Intensity of low back pain
Changes from baseline in the intensity of low back pain assessed by the Numerical Rating Scale
Measured: Weeks 2, 4, 8, 16, and 24
Intensity of leg pain
Changes from baseline in intensity of leg pain assessed by the Numerical Rating Scale
Measured: Weeks 2, 4, 8, 16, and 24
Level of disability
Changes from baseline in the level of disability assessed by the Roland-Morris Disability Questionnaire
Measured: Weeks 2, 4, 8, 16, and 24
Performance status
Changes from baseline in functional status assessed by the Japanese Orthopaedic Association Score
Measured: Weeks 2, 4, 8, 16, and 24
Severity of depression
Changes from baseline in the severity of depression assessed by the Hamilton Depression Rating Scale
Measured: Weeks 2, 4, 8, 16, and 24
Severity of anxiety
Changes from baseline in the severity of anxiety assessed by the Hamilton Anxiety Rating Scale
Measured: Weeks 2, 4, 8, 16, and 24
Sleep quality
Changes from baseline in sleep quality assessed by the Insomnia Severity Index
Measured: Weeks 2, 4, 8, 16, and 24
Pain self-efficacy
Changes from baseline in pain self-efficacy assessed by the Pain self-efficacy questionnaire
Measured: Weeks 2, 4, 8, 16, and 24
Use of analgesics
The proportion of patients who used analgesics for emergency.
Measured: Weeks 8 and 24
Incidence of lumbar spine surgery
The incidence of lumbar spine surgery during the follow-up
Measured: Weeks 8 and 24
Incidence of any adverse events
Adverse events be reported by patients and determined by clinicians.
Measured: Weeks 8 and 24
Incidence of treatment-related adverse events
Treatment-related adverse events include adverse events caused by electroacupuncture or sham electroacupuncture treatment.
Measured: Weeks 8 and 24
Incidence of serious adverse event
Serious adverse events refer to adverse events that require hospitalization or an extended hospital stay, result in disability, pose a threat to life, or cause death.
Measured: Weeks 8 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start15 Oct 2024 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion25 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lumbar Disc HerniationStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Zhou, Jiangxi University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611332
- Sponsor's protocol ID
- JXUCM-ACU-01
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang Y, Liu L, Yuan L, Liu X, Ding H, Zhou X, Cao Q. A Randomized, Sham-Controlled Trial on the Efficacy and Safety of Electroacupuncture for Lumbar Disc Herniation with Radiculopathy: Rationale and Study Protocol. J Pain Res. 2025 May 5;18:2307-2319. doi: 10.2147/JPR.S512711. eCollection 2025.
PubMed 40352817
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Electroacupuncture on Lumbar Disc Herniation with Radiculopathy: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06611332
- Acronym / sponsor ID
- JXUCM-ACU-01
- Conditions
- Lumbar Disc Herniation, Radiculopathy Lumbar
- Keywords
- electroacupuncture, radiculopathy, sham control, randomized controlled trial, lumbar disc herniation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Jiangxi University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 25 Oct 2025 (estimated)
- First posted
- 24 Sep 2024 (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.
Lumbar disc herniation with radiculopathy (LDHR) is the local displacement of the intervertebral disc and its contents beyond the edge of the normal intervertebral disc space, resulting in pain, weakness or numbness in the muscle or dermatomal distribution area. Electroacupuncture is based on obtaining the needling sensation manually and applying electrical stimulation of different frequencies and intensities, aiming to enhance the intensity of acupoint stimulation to improve the effect. As a kind of acupoint stimulation therapy, electroacupuncture has shown analgesic effects in animal experiments. However, at present, the clinical evidence of electroacupuncture applied in the treatment of LDHR is still insufficient. Therefore, this randomized, single-blind, sham electroacupuncture controlled trial aims to evaluate the efficacy and safety of electroacupuncture as a treatment for LDHR.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electroacupuncture | Experimental | Other: Electroacupuncture |
| Sham electroacupuncture | Sham comparator | Other: Sham electroacupuncture |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged from 18 to 70 years old.
- With intervertebral disc protrusion confirmed by a MRI or CT, accompanied by radicular pain in the lower extremities.
- With a NRS score ≥ 4 points for both low back pain and leg pain, and the pain lasts for at least 3 months;
- Voluntarily participating the trial and signing the informed consent form.
Key exclusion criteria (7 listed)
- Previous surgical treatment of the spine.
- Received any physical therapy for lumbar disc herniation within the recent 3 months.
- Complicated with diseases that can cause low back and leg pain.
- Symptomatic foraminal stenosis caused by severe degenerative diseases, accompanied by severe nerve injuries.
- Previous severe mental illness, organ failure, or malignant tumor.
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 |
|---|---|---|
| ElectroacupunctureThe main acupoints selected for the electroacupuncture group are bilateral BL23, bilateral BL25, bilateral GB30, bilateral LR11, bilateral LR8, GV4, GV3, and the affected BL40, and the secondary acupoints selected are bilateral BL54, the affected side BL57 and the affected side BL60.The treatment will be administered once every other day for 30 minutes each time, lasting for 8 consecutive weeks, totaling 24 sessions. | Other | Electroacupuncture |
| Sham electroacupunctureIn the sham electroacupuncture group, the acupoints will be at a position 2 cm lateral to the correct acupoints horizontally. The dosage and treatment course are the same as those in the electroacupuncture group. | Other | Sham electroacupuncture |
Primary outcome
Proportion of responders
Time frame: Weeks 8 and 24
Definition of a response: a reduction of at least 2 points in the score of the Numerical Rating Scale for both low back pain and leg pain.
13 secondary outcomes
Intensity of low back pain
Time frame: Weeks 2, 4, 8, 16, and 24
Intensity of leg pain
Time frame: Weeks 2, 4, 8, 16, and 24
Level of disability
Time frame: Weeks 2, 4, 8, 16, and 24
Performance status
Time frame: Weeks 2, 4, 8, 16, and 24
Severity of depression
Time frame: Weeks 2, 4, 8, 16, and 24
Severity of anxiety
Time frame: Weeks 2, 4, 8, 16, and 24
Sleep quality
Time frame: Weeks 2, 4, 8, 16, and 24
Pain self-efficacy
Time frame: Weeks 2, 4, 8, 16, and 24
Use of analgesics
Time frame: Weeks 8 and 24
Incidence of lumbar spine surgery
Time frame: Weeks 8 and 24
Incidence of any adverse events
Time frame: Weeks 8 and 24
Incidence of treatment-related adverse events
Time frame: Weeks 8 and 24
Incidence of serious adverse event
Time frame: Weeks 8 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Derived from this study: PubMed 40352817Yang Y, Liu L, Yuan L, Liu X, Ding H, Zhou X, Cao Q. A Randomized, Sham-Controlled Trial on the Efficacy and Safety of Electroacupuncture for Lumbar Disc Herniation with Radiculopathy: Rationale and Study Protocol. J Pain Res. 2025 May 5;18:2307-2319. doi: 10.2147/JPR.S512711. eCollection 2025.
- 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. This study is not recruiting at the moment.
The Affiliated Hospital of Jiangxi University of Chinese Medicine
Jiangxi, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electroacupuncture in people with Lumbar Disc Herniation and Radiculopathy Lumbar, run by Jiangxi University of Traditional Chinese Medicine 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 4 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: status not confirmed, as of the sponsor's last update on 24 Sep 2024. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of responders (time frame: Weeks 8 and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06611332, which also lists 1 linked publication.
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 24 Sep 2024.