Prospective Randomized Controlled Trial Comparing Conservative Therapies for the Alleviation of Knee Pain in Knee Osteoarthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain scores on visual analogue scale (VAS)
研究概览
简要总结
Patients with chronic knee pain attributed to osteoarthritis and referred to orthopedics as potential candidates for a knee replacement will receive standard physiotherapy or myofascial-specific therapy over 8 weeks. Based on the investigators pilot investigation, the investigators expect those who receive myofascial-specific therapy to experience reduced pain (compared to the standard therapy group) and increased flexibility compared to baseline levels. This simple conservative therapy could postpone (or in some cases, eliminate) the need for a knee replacement since pain is the major indication for surgery. If successful, this treatment could improve the quality of life and increase productivity for thousands suffering from knee osteoarthritis and preserve valuable health care resources.
详细描述
Approvals (Ethics Board and Health Canada) have already been obtained for the currently proposed prospective randomized, single-blinded, controlled clinical trial. The overall objective of the current investigation is to determine whether myofascial pain-specific therapy (which includes trigger-point injections and myofascial-specific physiotherapy) provides better pain relief and improves knee function compared to the standard-of-care physiotherapy in patients who are referred to orthopedics as potential surgical candidates. Specifically, the investigators hypotheses are that: Patients with knee osteoarthritis (OA) and who may be candidates for total knee arthroplasty 1) will have significantly reduced pain (compared to those who receive standard of care physiotherapy) and improved function (compared to baseline) with myofascial pain therapy and 2) those receiving myofascial therapy will have a delayed and/or reduced need for TKA compared to the standard-of-care physiotherapy group.
Patients with chronic knee pain attributed to osteoarthritis and referred to orthopedics as potential candidates for a knee replacement will receive standard physiotherapy or myofascial-specific therapy over 8 weeks.
The Primary outcome will be pain scores (10 point visual analogue scale (VAS)) in participants following standard-of-care physiotherapy versus myofascial pain-specific therapy for 8 weeks.
The Secondary outcomes will include:
(Comparisons between and/or within groups where appropriate):
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of bi or unilateral knee OA
- •knee pain attributed to knee OA
- •referral to orthopedics as a potential candidate for knee total knee arthroplasty
- •ability to comprehend/sign consent, independent mobility without assistive devices
排除标准
- •allergy/contraindication to study medications (i.e., trigger point injections), previous knee replacement surgery
- •infections of clinical abnormalities other than knee OA that could cause the knee pain
- •other diagnosed chronic pain syndrome for which they are taking regular pain medications
- •pregnancy or breast-feeding
研究组 & 干预措施
standard physiotherapy
Standard of care physiotherapy for knee osteoarthritis (OA) patients who have been diagnosed with knee OA and may be candidates for total knee replacement (TKA)
干预措施: Standard Physiotherapy (Behavioral)
Myofascial-specific therapy
Patient undergo myofascial pain-specific therapy which includes trigger point injections at the same time points as the comparator (1 session every 2 weeks for 8 weeks)
干预措施: Myofascial-specific therapy (Other)
结局指标
主要结局
Pain scores on visual analogue scale (VAS)
时间窗: 8 weeks
次要结局
- Brief pain inventory (BPI)(biweekly for 8 weeks, 3 months, 6 months)
- Oxford knee score(biweekly for 8 weeks, 3 months, 6 months)
- McGill short pain questionnaire(biweekly for 8 weeks, 3 months, 6 months)
- timed up and go (TUG)(Baseline, 3 months)
- 6 minute walk test(Baseline, 3 months)
- Biodex functional tests(Baseline, 3 months)
- total knee arthroplasty? If so, when(6 month)
- VAS pain scores(biweekly up to 8 weeks, then 3 months & 6 months)
研究者
Dr. Gavin Wood
Principal Investigator
Queen's University