The Use of Electroacupuncture (EA) to Affect Pain, Function and Quality of Life in Patients With End Stage Knee Osteoarthritis (KOA) on a Total Knee Arthroplasty (TKA) Waitlist
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
研究概览
简要总结
A 3-armed pilot randomized controlled trial: electroacupuncture, sham acupuncture and waitlist groups.
详细描述
The purpose of this study is to determine the efficacy of EA as a treatment strategy in the end stage knee osteoarthritis (KOA) population waiting for total knee arthroplasty (TKA). The research objectives are to 1. To determine the efficacy of EA to provide pain relief, improve function and quality of life in the end stage KOA population who are waiting for TKA. 2. To determine if EA is superior to sham EA or waiting list groups in providing pain relief, improving function and quality of life in the end stage KOA population who are waiting for TKA.
Outcome measures will be collected from all 3 groups at baseline, mid point, completion and 6 week follow up.
Participants will be recruited from the Concordia Joint Replacement Group in Winnipeg, Manitoba.
Inclusion Criteria: participants are on a waiting list for TKA and do not have a surgical date within 3 months from the start of the study.Waiting list will be defined as having had consultation with an orthopaedic surgeon and having accepted an offer a TKA. The participants will be a minimum of 45 years old and have a NPRS ≥ 5.
Exclusion Criteria: knee pain caused by other disease or injury, arthroscopy within the past year, intra articular injection within the previous 3 months, painful ipsilateral hip OA. Participants scheduled for simultaneous bilateral TKA or revision will be excluded.
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
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants are on a waiting list for TKA and do not have a surgical date within 3 months from the start of the study.Waiting list will be defined as having had consultation with an orthopaedic surgeon and having accepted an offer a TKA. The participants will be a minimum of 45 years old and have a NPRS ≥ 5.
排除标准
- •Criteria: knee pain caused by other disease or injury, arthroscopy within the past year, intra articular injection within the previous 3 months, painful ipsilateral hip OA. Participants scheduled for simultaneous bilateral TKA or revision will be excluded.
- •Medical history: serious acute or chronic disease or psychiatric disorders, blood coagulation disorders.
- •Surgical history: implanted cardiac pacemakers, history of valve replacement, previous arthroplasty.
- •Other: allergy to needle components, needle phobia, pregnancy
结局指标
主要结局
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
时间窗: Baseline, 3 weeks, 6 weeks and 6 weeks after study completion
Disease specific outcome measure. Measuring change in disease specific function over 4 time points (as noted below). The WOMAC provides a multidimensional assessment inclusive of activities of daily life (ADL's), functional mobility, gait, general health, and quality of life organized into 3 subscales (pain, stiffness, physical function) consisting of 24 items scored on a 5-point scale from 0-4. Higher scores represent higher pain values or worse function for a total possible score of 96.
次要结局
- Numeric Pain Rating Scale (NPRS)(Baseline, 3 weeks, 6 weeks and 6 weeks after study completion)
- The Short Form McGill Pain Questionnaire (SF-MPQ)(Baseline, 2 weeks, 6 weeks, and 6 weeks after study completion)
- The Short Form-Survey 36 (SF-36)(Baseline, 3 weeks, 6 weeks and 6 weeks after study completion)
研究者
Janine Didyk
Principle Investigator
University of Manitoba