Warm Needle Acupuncture vs. Needle Acupuncture for Osteoarthritis of the Knee: A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 14
- 试验地点
- 2
- 主要终点
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
This is a two-armed randomised controlled pilot study that investigates the component efficacy of moxibustion for osteoarthritis of the knee. Participants will be randomised to receive either warm needle acupuncture or needle acupuncture. Participants and acupuncturists will be blinded to group allocation. The primary and secondary outcome measures are WOMAC and SF36 respectively. Qualitative interviews will be used to gather information on the patients' experiences and perceptions of the trial and the treatment provided.
It is hypothesised that warm needle acupuncture will lead to a greater reduction in clinical signs and symptoms than needle acupuncture.
详细描述
Acupuncture Treatment
All participants will receive acupuncture. Only points local to the knee will be used. There will be 4-6 points used per knee, therefore 8 -12 needles per treatment. A record will be kept of the points used at each treatment. Both knees will be treated even if only one knee is painful. This will ensure that participants receive similar treatments.
Patients will be treated seated, as this allows better access to the relevant acupuncture points. It also helps ensure the moxibustion is carried out safely.
Participants will receive 8 treatments in the first 4 weeks (twice a week), then 4 treatments in 4 weeks (once a week).
Blinding procedures
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic pain in at least one knee joint during the last six months.
- •At baseline the WOMAC pain score must be ≥ 3 points (on a scale of 0-10)
- •In addition to the knee pain at least 3 of the following 6 must be present:
- •Age > 50 years
- •Stiffness < 30 minutes
- •Bony Tenderness
- •Bony enlargement
- •No palpable warmth
- •Ability to speak English
- •Signed consent form
排除标准
- •A systemic disease of the musculoskeletal system.
- •Bone tumour, bone tumour like lesions or metastasis.
- •Bone fracture in the lower extremities during the last three months.
- •Acute infection or osteonecrosis in the knee joint.
- •Recent sprain injury to the knee joint.
- •Surgery of the afflicted extremity during the last six months or planned surgery.
- •Ongoing cortico-steroid therapy or cortisone injections in the past six weeks.
- •Taking anti-coagulant medication.
- •Coagulopathy.
- •Other pain condition that compels the patient to take analgesics for more than three days during the last four weeks.
- •Addiction to analgesics, opiate or other drugs.
- •Acupuncture treatment in the past 3 months.
- •Dermatological disease within the acupuncture area impairing acupuncture treatment.
- •Pregnant or breast-feeding patients.
- •Inability to follow instructions or understand the consent form (insufficient command of language, dementia).
- •Participation in another clinical study.
- •Ongoing legal proceedings concerning degree of disability.
结局指标
主要结局
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: Change from Baseline to follow up at 16 weeks
次要结局
- SF36 (Rand)(Change from Baseline to follow up at 16 weeks)