OsteoarthritisAKPNCT02003443
Acupressure for Knee Pain in Older Adults
A study testing Self-Administered Acupressure in people with Osteoarthritis, run by University of Michigan at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Self-Administered Acupressure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Feb 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Chronic Pain and Fatigue Research Center
Ann Arbor, Michigan, 48106
About this study
Official title: Acupressure for the Treatment of Pain in Older Adults With Symptomatic Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Osteoarthritis
- Being tested
- Self-Administered Acupressure
- Keywords
- Acupressure, Older Adults, Knee pain, Pain Treatment
- Medical subject headings
- Osteoarthritis, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Administered AcupressureBehavioural
The intervention involves teaching and supporting subjects to administer acupressure on themselves.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Self-Administered Acupressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
The Western Ontario McMaster Universities Osteoarthritis Index (WOMAC).
Measured: 4 and 8 Weeks
Secondary outcomes (1)
Physical Function
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.
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startAug 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lydia W Li, University of Michigan
- Investigators
- Lydia Li, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003443
- Sponsor's protocol ID
- N015749
- Other IDs
- 5968
- Acronym
- AKP
- Status last verified
- Jun 2022
- First submitted
- 2 Dec 2013
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28437570
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupressure for the Treatment of Pain in Older Adults With Symptomatic Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02003443
- Acronym / sponsor ID
- AKP / N015749
- Conditions
- Osteoarthritis
- Keywords
- Acupressure, Older Adults, Knee pain, Pain Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham Acupressure | Placebo comparator | Behavioral: Self-Administered AcupressureParticipants 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. |
| Usual Care | No intervention | –Participants assigned to the UC group will receive no intervention. |
| Pain-Relief Acupressure | Experimental | Behavioral: Self-Administered AcupressureParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-Administered AcupressureThe intervention involves teaching and supporting subjects to administer acupressure on themselves. | Behavioural | Pain-Relief Acupressure, Sham Acupressure |
Primary outcome
Pain
Time frame: 4 and 8 Weeks
The Western Ontario McMaster Universities Osteoarthritis Index (WOMAC).
1 secondary outcome
Physical Function
Time frame: 4 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Derived from this study: PubMed 28437570Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lydia Li, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Administered Acupressure in people with Osteoarthritis, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 4 and 8 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02003443, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.