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Completed

NCT Number: NCT02003443

Acupressure for Knee Pain in Older Adults

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Chronic Pain and Fatigue Research Center

Ann Arbor, Michigan, 48106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

self-administered acupressure

Behavioral

The intervention involves teaching and supporting subjects to administer acupressure on themselves.

Primary outcomes

  1. Pain

    Time frame: 4 and 8 Weeks

    The Western Ontario McMaster Universities Osteoarthritis Index (WOMAC).

Secondary outcomes

  1. Physical Function

    Time frame: 4 and 8 weeks

    Both objective and subjective assessments of physical function will be used. The 6 minute walk and the timed up and go (TUG) tests are the objective measures. The 6 minute walk test has been demonstrated to yield reliable measurements of exercise capacity and is frequently used in OA trials. The TUG is a test of functional ability and measures the time (in seconds) to get up from a chair, walk 20 feet and return to the chair. For subjective assessment, we will use the physical function subscale (17 items) of WOMAC.

Other outcomes

  1. Fatigue

    Time frame: 4 and 8 weeks

    Fatigue will be measured by the Brief Fatigue Inventory (BFI).

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Acronym: AKP

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 6, 2013
Registry last updated
Jun 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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