Clinical trial NCT02003443: Acupressure for Knee Pain in Older Adults
Official title: Acupressure for the Treatment of Pain in Older Adults With Symptomatic Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Acupressure
Older Adults
Knee pain
Pain Treatment
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2013-12-06
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain
timeFrame: 4 and 8 Weeks
Secondary outcomes:
measure: Physical Function
timeFrame: 4 and 8 weeks
Other outcomes:
measure: Fatigue
timeFrame: 4 and 8 weeks
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Chronic Pain and Fatigue Research Center
state: Michigan
Study officials:
affiliation: Regents of the University of Michigan
name: Lydia Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li LW, Harris RE, Tsodikov A, Struble L, Murphy SL. Self-Acupressure for Older Adults With Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial. Arthritis Care Res (Hoboken). 2018 Feb;70(2):221-229. doi: 10.1002/acr.23262. Epub 2017 Dec 29.