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临床试验/NCT02003443
NCT02003443已完成不适用

Acupressure for the Treatment of Pain in Older Adults With Symptomatic Knee Osteoarthritis

University of Michigan1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2013年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
1
主要终点
Pain

研究概览

简要总结

The primary objective of this project is to determine whether self-administered acupressure is an effective and feasible self-management strategy for older adults with symptomatic KOA. Participants will be randomized to three treatment groups: pain-relief acupressure, sham acupressure, and usual care (UC). The two acupressure groups will be taught to administer pain-relief and sham acupressure, respectively, on themselves 5 days/week for 8 weeks. The usual care group will not be required to change any of their treatment practice. Outcome data will be collected at baseline, and the 4th and 8th week after baseline.

详细描述

Knee osteoarthritis (KOA) is a leading cause of disability in the elderly and this disability is commonly attributed to knee pain. Current treatments for knee pain are only modestly efficacious, and some common treatments like non-steroidal anti-inflammatory drugs (NSAIDS) have adverse long-term effects. Acupressure is an inexpensive and noninvasive treatment that has the potential to be a useful long-term self-management strategy for pain. Acupressure can be easily taught and is safe enough to self-apply without supervision. Participants will be randomized to three treatment groups: pain-relief acupressure, sham acupressure, and usual care (UC). The intervention will last for 8 weeks during which participants in the pain-relief and sham acupressure groups will be taught the assigned treatment by a trained research assistant who is blinded to the treatment arm, and provided with a digital video disc to aid their practice at home. The UC group will not receive training from the research team or be required to change their treatment practice.Our research team will make weekly phone calls to all three groups of participants to ask about their pain levels and any adverse events. For the two acupressure groups, the phone calls serve to support the participants' adherence to treatment. Data will be collected at baseline, mid-point (4 weeks after baseline) and the end ( 8 weeks) of the intervention. These results will help us assess the efficacy of pain-relief acupressure on knee pain in older adults, and allow us to calculate effect sizes to determine the appropriate sample size for a larger future study. Since no studies have involved older adults in self-administered acupressure, information about feasibility of and adherence to using this method in older adults would be invaluable.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age 65 or older
  • •Community-living (i.e., own home, senior residence, apartment)
  • •Have a physician diagnosis of knee OA
  • •Current persistent pain (pain ≥ 4 on a 1-10 Visual Analogue Scale on 50% or more of days) that has lasted for 3 months or longer
  • •Ability to speak and write in English
  • •Adequate cognitive status (score > 5 on the 6-item screener)
  • •Adequate functional ability to administer the acupressure protocol (e.g., able to use fingers or device to apply pressure to acupoints, able to easily reach feet to access acupoints)
  • •Ability to demonstrate understanding of treatment protocol through demonstration after being instructed
  • •Ambulatory with or without an assistive device
  • •Adequate hearing and vision to follow study protocol
  • •Agree not to start any new therapy for pain control during the study period
  • •Have a telephone and television

排除标准

  • •Receiving active cancer treatment
  • •Have a bleeding diathesis condition
  • •Have health conditions that could confound the effect of acupressure (e.g., rheumatoid arthritis, lupus, diabetic neuropathy)
  • •Had knee replacement surgery
  • •Planned or current involvement in physical therapy, acupuncture or acupressure during the study period or receipt of any of these in the previous 3 months
  • •Knee injection in prior 6 weeks with no planned injection during the study period
  • •Chronic use of opioid therapy

研究组 & 干预措施

Sham Acupressure

Placebo Comparator

Participants assigned to sham acupressure will receive similar instruction as those assigned to pain-relief acupressure, except that they will be taught to apply pressure to 10 acupoints that are unrelated to pain. That is, they will conduct self-administered acupressure 5 days/week for 8 weeks, as the pain-relief acupressure group does, but on 'sham' acupoints.

干预措施: Self-Administered Acupressure (Behavioral)

Usual Care

No Intervention

Participants assigned to the UC group will receive no intervention.

Pain-Relief Acupressure

Experimental

Participants assigned to pain-relief acupressure will be taught to apply physical pressure, using a wooden hand-held device designed for acupressure, to 10 acupoints on their body.That is, they will conduct self-administered acupressure 5 days/week for 8 weeks,on acupoints that are relevant to pain reduction.

干预措施: Self-Administered Acupressure (Behavioral)

结局指标

主要结局

Pain

时间窗: 4 and 8 Weeks

The Western Ontario McMaster Universities Osteoarthritis Index (WOMAC).

次要结局

  • Physical Function(4 and 8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lydia W Li

Associate Professor

University of Michigan

研究点 (1)

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