NCT02003443

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

June 14, 2022

Status Verified

June 1, 2022

Enrollment Period

1.5 years

First QC Date

December 2, 2013

Last Update Submit

June 13, 2022

Conditions

Keywords

AcupressureOlder AdultsKnee painPain Treatment

Outcome Measures

Primary Outcomes (1)

  • Pain

    The Western Ontario McMaster Universities Osteoarthritis Index (WOMAC).

    4 and 8 Weeks

Secondary Outcomes (1)

  • Physical Function

    4 and 8 weeks

Other Outcomes (1)

  • Fatigue

    4 and 8 weeks

Study Arms (3)

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.

Behavioral: Self-Administered Acupressure

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.

Behavioral: Self-Administered Acupressure

Interventions

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

Pain-Relief AcupressureSham Acupressure

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Chronic Pain and Fatigue Research Center

Ann Arbor, Michigan, 48106, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

OsteoarthritisAgnosia

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Lydia Li, PhD

    Regents of the University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 2, 2013

First Posted

December 6, 2013

Study Start

August 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

June 14, 2022

Record last verified: 2022-06

Locations