Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture | Experimental |
| |
| Sham electroacupuncture | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 8 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity of low back pain | Changes from baseline in the intensity of low back pain assessed by the Numerical Rating Scale | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Jiangxi University of Chinese Medicine | Jiangxi | Nanchang | 330006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40352817 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| D011843 | Radiculopathy |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
Not provided
Not provided
| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Sham electroacupuncture | Other | 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. |
|
| 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 | Weeks 2, 4, 8, 16, and 24 |
| Performance status | Changes from baseline in functional status assessed by the Japanese Orthopaedic Association Score | 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 | 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 | Weeks 2, 4, 8, 16, and 24 |
| Sleep quality | Changes from baseline in sleep quality assessed by the Insomnia Severity Index | Weeks 2, 4, 8, 16, and 24 |
| Pain self-efficacy | Changes from baseline in pain self-efficacy assessed by the Pain self-efficacy questionnaire | Weeks 2, 4, 8, 16, and 24 |
| Use of analgesics | The proportion of patients who used analgesics for emergency. | Weeks 8 and 24 |
| Incidence of lumbar spine surgery | The incidence of lumbar spine surgery during the follow-up | Weeks 8 and 24 |
| Incidence of any adverse events | Adverse events be reported by patients and determined by clinicians. | Weeks 8 and 24 |
| Incidence of treatment-related adverse events | Treatment-related adverse events include adverse events caused by electroacupuncture or sham electroacupuncture treatment. | 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. | Weeks 8 and 24 |
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |