Efficacy and safety of warm acupuncture compared to gabapentin in the management of pain in patients with sciatica in Bhutan: a randomized non-inferiority trial

Phase 1

• Conditions: Traditional Chinese Medicine; Patients clinically diagnosed with sciatica; Gabapentin; Sciatica; Acupuncture

• Registration Number: TCTR20220211005
• Lead Sponsor: Ministry of Health, Thimphu, Bhutan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-11
• Study Completion: 2022-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

Symptoms of sciatica for 1 month or longer from the onset

Exclusion Criteria

Patients with:
-Surgery for lumbar disc herniation within the past 6 months;
-Antiepileptic, antidepressant , opioids or corticosteroids;
-Cardiovascular, liver, kidney, or hematopoietic system diseases, mental health disorders or cancer;
-Cauda equina syndrome;
-Pregnant, breastfeeding, or planning to conceive;
-Acupuncture therapy within the past 6 months.
-Physical disabilities.
-History of metal allergies
-Infection at the site of needle insertion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain 0, 15, 30 d isual analog score chart (VAS)

Secondary Outcome Measures

Name	Time	Method
Disability 0, 15, 30 d Roland Questionnaire for LBP and Disability assessment,Disability 0, 15, 30 d oland Questionnaire for LBP and Disability assessment