The Effect of Flexible Tape Versus Placebo Tape in Patients Completing a Home Exercise Program With Knee Osteoarthritis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change in pain on visual analogue scale
研究概览
简要总结
People with osteoarthritis (OA) of the knee attending The Alfred hospital will be invited to participate in a randomised controlled trial comparing two different types of knee taping. Both groups will also be prescribed an exercise program to assist in management of their knee OA.
Hypothesis are as follows:
- Participants treated with flexible tape with have greater reductions in pain and improvements on timed performance based measures when compared to those treated with a placebo tape.
- Participants in both groups will have clinically significant improvements in pain and timed performance based measures compared to their baseline scores.
详细描述
Interventions:
Participants in both groups will attend physiotherapy on 4 occasions, in addition to an initial appointment where baseline data will be collected.
All participants will be provided with an individualised home exercise program. This will be provided based on the investigators' clinical experience and evidence based programs. The participant will be provided with a handout detailing the exercises they are to complete, including dosage. If there is excessive pain or difficulty associated with completing an exercise the participant will be advised to cease that particular exercise until they have been reviewed by the researcher the following week.
Participants will have their knee taped according to either the therapeutic flexible taping protocol, or the placebo taping protocol depending on which group they have been randomly allocated to on three occasions at one week intervals. All participants will be provided with written information regarding tape allergies and when to remove the tape from their knee. To control for the Hawthorne effect participants will not be aware of whether they are in the intervention or placebo group.
Participants will attend for appointments once per week for three weeks. They will then have a three week period of no intervention and return for a review and completion of the study. At this time the participant can be referred for further physiotherapy intervention as is clinically indicated. This may include physiotherapy at The Alfred Hospital, private practice or the participants' local health services.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of osteoarthritis of the knee
- •radiological diagnosis of osteoarthritis of the knee
- •able to understand basic English
- •knee outcome and injury scale available in patients's preferred language
排除标准
- •other significant lower limb pathology
- •previous total knee replacement in effected knee
- •co-morbidities limiting participation in a basic home exercise program or performance of outcome measures eg. unstable cardiac or respiratory conditions
结局指标
主要结局
Change in pain on visual analogue scale
时间窗: baseline, 0,3 and 6 weeks after commencement of intervention
• Pain on a Visual Analogue Scale (VAS) over last 48hrs at rest and movement. Anchors used will be no pain and worst imaginable pain. The VAS has been found to be valid, reliable and sensitive to change in this population (Tubach et al, 2005)
次要结局
- Chang in Knee injury and osteoarthritis outcome score (excluding sport domain)(baseline, one week, three weeks and six weeks)
研究者
Kim McManus
Physiotherapist
The Alfred