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This multicenter randomized controlled trial (RCT) will evaluate the therapeutic effectiveness and health-economics of electroacupuncture for sciatica due to intervertebral disc displacement in 3 compared groups: electroacupuncture, electroacupuncture plus traction, electroacupuncture plus traction and medication.
This is a multicenter RCT with 3 groups to determine the effectiveness and health economic evaluation of the electroacupuncture for sciatica due to intervertebral disc displacement in a population of adults aged 18-65. 324 participants who meet the inclusion criteria will be randomly allocated into 3 different groups, namely electroacupuncture group, electroacupuncture & traction group, electroacupuncture & traction & oral medication group.
All participants will receive six-week treatment, the participants in electroacupuncture group will receive electroacupuncture only, electroacupuncture & traction group will receive both electroacupuncture and traction, and in electroacupuncture & traction & oral medication group all of the three therapies are adopted.
The statistical analysis will be conducted by a third party who is masked to the allocation of participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electroacupuncture (EA) | Experimental | Use Electroacupuncture only |
|
| EA + Traction | Other | Use electroacupuncture and traction together |
|
| EA + Traction + Oral Medication | Other | Combine electroacupuncture, traction and oral medication (Voltaren and Vitamin B1) together for treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electroacupuncture (EA) | Other | Main acupoints: Da chang shu (BL25), Huan tiao (GB30), bilateral Jiaji point of attacked lumbar vertebra, Ashi points, modifying points according to different patterns. Electroacupuncture: choose the dilatational wave, frequency is 2Hz/100Hz, electric current ranges from 0.1mA to 1.0mA, 30 mins per time. Treatment frequency: 5 times per week in the first 2 weeks, 3 times per week in the 3rd and 4th week, 2 times per week in the 5th and 6th week. Duration: 6 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale(VAS) of Leg Pain | Change from baseline in VAS of Leg Pain at 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scale(VAS) of Low Back Pain | Change from baseline in VAS of Low Back Pain at 6 weeks | |
| Simplified McGill Pain Questionnaire (ST-MPQ) | Change from baseline in ST-MPQ at 6 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi Wu, A.P. | Contact | 86-15928830710 | wuxi403@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xi Wu, A.P. | School of Acupunture& Tuina, Chengdu University of Traditional Chinese Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu university of Traditonal Chinese Medcine | Recruiting | Chengdu | Sichuan | 610075 | China |
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| ID | Term |
|---|---|
| D012585 | Sciatica |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D020426 | Sciatic Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D015671 | Electroacupuncture |
| D014143 | Traction |
| D004008 | Diclofenac |
| D013831 | Thiamine |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D015670 | Acupuncture Therapy |
| D000529 | Complementary Therapies |
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|
| Traction | Other | An electric pelvis traction in supine position will be applied. The treatment frequency and duration are the same as EA. |
|
| Voltaren | Drug | Medication: 50 mg, twice per day Treatment frequency: In the first 2 weeks, take medicine for continuous 5 days with a 2-day interval each week; in the 3rd and 4th week, take medicine every 2 days, totally 3 times each week; in the 5th and 6th week, take medicine every 3 days, totally 2 times each week. Duration: 6 weeks. |
|
|
| Vitamin B1 | Drug | Medication: 10mg, twice per day. Treatment frequency: In the first 2 weeks, take medicine for continuous 5 days with a 2-day interval each week; in the 3rd and 4th week, take medicine every 2 days, totally 3 times each week; in the 5th and 6th week, take medicine every 3 days, totally 2 times each week. Duration: 6 weeks. |
|
|
| Improved Roland Functional questionaire(RDQ) |
| Change from baseline in RDQ at 6 weeks |
| Likert Overall Recovery Self Rating Scale (7 points) | Change from baseline in Likert Overall Recovery Self Rating Scale at 6 weeks |
| The Medical Outcomes Study 36-Item Short -Form Health Survey Questionnaire (SF-36) | Change from baseline in SF-36 at 6 weeks |
| Sciatica Frequency and Bothersome Index (SFBI) | Change from baseline in SFBI at 6 weeks |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D004599 |
| Electric Stimulation Therapy |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |