Back to resultsAcupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis
Primary Purpose
Sleep, Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Sponsored by
About this trial
This is an interventional trial for Sleep
Eligibility Criteria
Inclusion Criteria:
- 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].
Exclusion Criteria:
- 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,
- 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.
Sites / Locations
- Wesley Woods Geriatric Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Real acupuncture
Sham acupuncture
Arm Description
Real acupuncture
Sham acupuncture
Outcomes
Primary Outcome Measures
Sleep disturbances as recorded by wrist actigraph, including sleep duration and sleep efficiency. Pain as measured by 0-10 VAS and WOMAC pain scores.
Secondary Outcome Measures
WOMAC disability scores, IDEEA gait patterns and activity levels, medication type and amount consumed, side effects, and medical care utilization.
Full Information
NCT ID
NCT00694447
First Posted
June 6, 2008
Last Updated
November 19, 2013
Sponsor
Emory University
Collaborators
Southeast Center of Excellence in Geriatric Medicine, The John A. Hartford Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00694447
Brief Title
Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis
Official Title
Exploring Outcomes and Mechanisms of Acupuncture in Treating Pain and Sleep Disturbance in Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Southeast Center of Excellence in Geriatric Medicine, The John A. Hartford Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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).
Main effects of acupuncture on sleep improvement and pain relief are anticipated when acupoints are separately targeted for sleep and for pain, respectively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Pain
7. Study Design
Study Phase
Not Applicable
8. Arms, Groups, and Interventions
Arm Title
Real acupuncture
Arm Type
Experimental
Arm Description
Real acupuncture
Arm Title
Sham acupuncture
Arm Type
Sham Comparator
Arm Description
Sham acupuncture
Intervention Type
Procedure
Intervention Name(s)
Acupuncture
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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].
Exclusion Criteria:
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,
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Huang, MD, PhD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wesley Woods Geriatric Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis
We'll reach out to this number within 24 hrs