Chronic Non-specific, Uncomplicated Neck Pain Clinical Trial
Official title:
Clinical Research on the Efficacy and Safety of East-West Collaborative Treatment Using NSAIDs and BV on Chronic Cervical Pain; A Randomized, Controlled, Parallel, Pilot Study
| Verified date | November 2015 |
| Source | Kyunghee University Medical Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Korea: Institutional Review Board |
| Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of east-west collaborative treatment using bee venom acupuncture and NSAIDs on pain intensity, functional status and quality of life of patients with chronic cervicalgia
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | July 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - age between 18 and 65 years - nonspecific, uncomplicated, chronic neck pain over 3 months - volunteer can read and write in Korean, providing written informed consent Exclusion Criteria: - exhibited abnormalities on neurological examination - radicular pain - serious spinal disorders including malignancy, vertebral fracture, spinal infection or inflammatory spondylitis - other chronic diseases that could affect or interfere with the therapeutic outcomes including cardiovascular disease, diabetic neuropathy, active hepatitis, fibromyalgia, rheumatoid arthritis, dementia or epilepsy - previous spinal surgery or scheduled procedures during the study - painful conditions induced by traffic accidents - a substantial musculoskeletal problem generating pain from an area other than the neck - conditions for which administration of BVA might not be safe including clotting disorders, administration of an anticoagulant agent, pregnancy and seizure disorders - a documented hypersensitive reaction to previous BVA treatments, bee stings or insect bites - positive reaction observed during a skin hypersensitivity test - severe psychiatric or psychological disorders - current use of corticosteroids, narcotics, muscle relaxants or herbal medicines to treat neck pain or any medication considered inappropriate by the investigator - pending lawsuits or receipt of compensation due to neck pain. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Spine Center, Kyung Hee University Hospital at Gangdong | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Kyunghee University Medical Center | Korea Institute of Oriental Medicine, Kyung Hee University, Kyung Hee University Hospital at Gangdong |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Skin Roll Test | Changes from baseline in skinfold thickness and pressure algometer scores at 4th and 8th week follow-up | No | |
| Primary | Visual Analogue Scale for bothersomeness | Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up | No | |
| Secondary | Neck Disability Index | Changes from baseline in NDI at 2nd, 3rd, 4th and 8th week follow-up | No | |
| Secondary | Depression scores on Beck's Depression Inventory | Changes from baseline in BDI at 4th and 8th week follow-up | No | |
| Secondary | Quality of Life scores on EQ-5D | Changes from baseline in EQ-5D at 2nd, 3rd, 4th and 8th week follow-up | No | |
| Secondary | Quality of Life scores on SF-36 | Changes from baseline in SF-36 at 4th and 8th week follow-up | No | |
| Secondary | Visual Analogue Scale for pain intensity | Changes from baseline in VAS at 1st, 2nd, 3rd, 4th and 8th week follow-up | No | |
| Secondary | Safety profile | Any adverse events must be documented and reported. | At every visit, up to 2 months | Yes |
| Secondary | Credibility test | Changes from baseline in credibility test at 4th week follow-up | No |