Electroacupuncture for Relieving Pain in Ankylosing Spondylitis: a Single-arm Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Pain Severity Numerical Rating Scale (NRS)
研究概览
简要总结
Background: Ankylosing spondylitis imposes burdens on individuals and society that AS costs 3 times higher than general population. Conventional approaches for AS have their limitation. Previous studies demonstrated acupuncture has significant therapeutic effects for AS in diminishing joint pain, enhancing functional disorders and modifying spinal deformity. Although acupuncture is effective in relieving pain in AS patients, the evidence is very limited due to methodological flaws.
Design This study will be a single-arm pilot study in patients with AS. Eligible subjects will receive electroacupuncture treatment twice per week for at least 6 weeks (12 sessions in total). The length of treatment can be extended to a maximum of 10 weeks (20 sessions in total) if participants request a prolonged treatment. The acupuncturist, who is a registered Chinese medicine practitioner, of this trial will not participate in data collection and data entry.
Objective: To explore the treatment effect of electroacupuncture for relieving pain in ankylosing spondylitis.
Setting: Hong Kong
Participants: 20 subjects with a diagnosis of ankylosing spondylitis
Main Measures: Pain Severity Numerical Rating Scale (NRS), Adverse events
Data analysis All data will be double-entered and checked for consistency before conducting the analysis. Binomial test will be used to analyze the percentage of responders to treatment compared with a reference value of 10%. Wilcoxon signed rank test will be used to compare the values of all continuous variables between baseline and post treatment. The population for safety analyses will include all subjects who receive at least one acupuncture treatment. Adverse events will be coded using the WHO Adverse Reaction Terminology Dictionary. Special attention will be given to those subjects who have discontinued treatment due to adverse events or who experience serious adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •with a diagnosis of AS and fulfilled either ASAS criteria or Modified New York criteria,
- •Bath Ankylosing Spondylitis Disease Activity Index, BASDAI ≥4,
- •currently taking analgesic or NSAIDs for pain control,
- •spinal pain assessment score≥4 on a numerical rating scale (NRS; 0-10 scale)
排除标准
- •having active skin lesion or open wound over the needle placement areas;
- •having heart disease, bleeding disorder or taking anticoagulant drugs
- •have previous acupuncture experience 12 months before the baseline,
- •are pregnant, breast-feeding or of childbearing potential but not using adequate contraception;
- •having psoriasis, rheumatoid arthritis, osteoarthritis, psoriatic arthritis or reactive arthritis;
- •having unstable medical condition such as liver and/or kidney failure or cancers.;
- •concurrently taking or injecting steroid.
结局指标
主要结局
Change in Pain Severity Numerical Rating Scale (NRS)
时间窗: week 0 and 6
次要结局
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)(week 0, 6, 10 and 18)
- Change in Pain Severity Numerical Rating Scale (NRS)(week 0, 2, 4, 8, 10, 12, 14, and 18)
- Bath Ankylosing Spondylitis Functional Index (BASFI)(week 0, 6, 10 and 18)
- Quality of life of patients as evaluated by SF-36(week 0, 6, 10 and 18)
- Erythrocyte sedimentation rate (ESR)(week 0, 6, 10 and 18)
- Types and dosage of drug(s) intake(week 0, 2, 4, 6, 8, 10, 12, 14 and 18)
- Bath Ankylosing Spondylitis Global Index (BASGI)(week 0, 6, 10 and 18)
- Bath Ankylosing spondylitis Metrology Index (BASMI)(week 0, 6, 10 and 18)
- Joints count(week 0, 6, 10 and 18)
- Chest expansion as measured by the change in circumference at 4th intercostal level between maximal inspiration and expiration in cm(week 0, 6, 10 and 18)
- C-reactive protein (CRP)(week 0, 6, 10 and 18)
研究者
Professor LAO Lixing
Director, School of Chinese Medicine
The University of Hong Kong