SleepNCT00694447
Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis
A study testing Acupuncture in people with Sleep and Pain, run by Emory University at 1 site in United States.
Trial summary
The hypotheses of this study are: In the older population with knee OA, When acupoints are chosen for both sleep and pain, there are additive effects on sleep improvement and pain relief (i.e. no interaction). Read more about this study
- Who is it for?
- Ages 55 years and older
- What is being tested?
- Acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Apr 2008
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with knee osteoarthritis, diagnosed by the ACR clinical diagnosis criteria for idiopathic OA, with at least Kellgren and Lawrence grading II and above. AND,
- Present with knee pain at least half of the time. AND,
- Complain of sleep disturbances associated with knee OA, with Pittsburgh Sleep Quality Index > 5 [36].
Who cannot join
- Patients with diagnosis of obstructive sleep apnea (OSA). OR,
- Patients with dense hemiplegia secondary to cerebrovascular accident. OR,
- NYHA Class III - patients with heart failure condition limited by minimal activity. OR,
- Severe COPD with shortness of breath at minimal exertion. OR,
- Peripheral vascular disease with severe claudication. OR,
- Dementia with Mini Mental Status Exam score of 20 or less. OR,
Show all 10Show fewer
- Patients who received knee intra-articular corticosteroid injection within 4 weeks prior to the study or who received acupuncture treatment within 6 months. OR,
- Unwilling to come off narcotic pain medication. OR,
- History of bleeding diathesis or currently on anticoagulation. OR,
- Patients currently engaged in medical legal cases related to OA or disability.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wesley Woods Geriatric Hospital
Atlanta, Georgia, 30329
About this study
Official title: Exploring Outcomes and Mechanisms of Acupuncture in Treating Pain and Sleep Disturbance in Knee Osteoarthritis
The hypotheses of this study are: In the older population with knee OA,
- When acupoints are chosen for both sleep and pain, there are additive effects on sleep improvement and pain relief (i.e. no interaction).
- Main effects of acupuncture on sleep improvement and pain relief are anticipated when acupoints are separately targeted for sleep and for pain, respectively.
- Being tested
- Acupuncture
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcupunctureProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Real acupuncture | Experimental | Real acupuncture Receives: Procedure: Acupuncture |
| Sham acupuncture | Sham comparator | Sham acupuncture Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep disturbances as recorded by wrist actigraph, including sleep duration and sleep efficiency. Pain as measured by 0-10 VAS and WOMAC pain scores.
Measured: at least 3 months
Secondary outcomes (1)
WOMAC disability scores, IDEEA gait patterns and activity levels, medication type and amount consumed, side effects, and medical care utilization.
Measured: at least 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2008 (estimated)
- Study startFeb 2007
- Primary completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Southeast Center of Excellence in Geriatric Medicine, The John A. Hartford Foundation
- Responsible party
- Principal investigator, Wei Huang MD, PhD, Emory University
- Investigators
- Wei Huang, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00694447
- Sponsor's protocol ID
- IRB00000143
- Other IDs
- Grant #97333-G
- Status last verified
- Nov 2013
- First submitted
- 6 Jun 2008
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Outcomes and Mechanisms of Acupuncture in Treating Pain and Sleep Disturbance in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT00694447
- Acronym / sponsor ID
- IRB00000143
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Southeast Center of Excellence in Geriatric Medicine, The John A. Hartford Foundation
- Study start
- Feb 2007
- Primary completion
- Apr 2008 (actual)
- First posted
- 10 Jun 2008 (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 hypotheses of this study are: In the older population with knee OA,
- When acupoints are chosen for both sleep and pain, there are additive effects on sleep improvement and pain relief (i.e. no interaction).
- Main effects of acupuncture on sleep improvement and pain relief are anticipated when acupoints are separately targeted for sleep and for pain, respectively.
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Real acupuncture | Experimental | Procedure: AcupunctureReal acupuncture |
| Sham acupuncture | Sham comparator | Procedure: AcupunctureSham acupuncture |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with knee osteoarthritis, diagnosed by the ACR clinical diagnosis criteria for idiopathic OA, with at least Kellgren and Lawrence grading II and above. AND,
- Present with knee pain at least half of the time. AND,
- Complain of sleep disturbances associated with knee OA, with Pittsburgh Sleep Quality Index > 5 [36].
Key exclusion criteria (10 listed)
- Patients with diagnosis of obstructive sleep apnea (OSA). OR,
- Patients with dense hemiplegia secondary to cerebrovascular accident. OR,
- NYHA Class III - patients with heart failure condition limited by minimal activity. OR,
- Severe COPD with shortness of breath at minimal exertion. OR,
- Peripheral vascular disease with severe claudication. OR,
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 |
|---|---|---|
| Acupuncture | Procedure or surgery | Real acupuncture, Sham acupuncture |
Primary outcome
Sleep disturbances as recorded by wrist actigraph, including sleep duration and sleep efficiency. Pain as measured by 0-10 VAS and WOMAC pain scores.
Time frame: at least 3 months
1 secondary outcome
WOMAC disability scores, IDEEA gait patterns and activity levels, medication type and amount consumed, side effects, and medical care utilization.
Time frame: at least 3 months
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 21 Nov 2013.
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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.
Wei Huang, MD, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acupuncture in people with Sleep and Pain, run by Emory University 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 3 inclusion and 10 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 21 Nov 2013. 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?
Sleep disturbances as recorded by wrist actigraph, including sleep duration and sleep efficiency. Pain as measured by 0-10 VAS and WOMAC pain scores. (time frame: at least 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2013.