Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis

Not Applicable

Completed

• Conditions: Sleep; Pain
• Interventions: Procedure: Acupuncture

• Registration Number: NCT00694447
• Lead Sponsor: Emory University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2008-04
• Study First Submitted: 2008-06-06
• Study First Submitted QC: 2008-06-09
• Study First Posted: 2008-06-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-19
• Last Update Posted: 2013-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. 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,
2. Present with knee pain at least half of the time. AND,
3. Complain of sleep disturbances associated with knee OA, with Pittsburgh Sleep Quality Index > 5 [36].

Exclusion Criteria

1. Patients with diagnosis of obstructive sleep apnea (OSA). OR,
2. Patients with dense hemiplegia secondary to cerebrovascular accident. OR,
3. NYHA Class III - patients with heart failure condition limited by minimal activity. OR,
4. Severe COPD with shortness of breath at minimal exertion. OR,
5. Peripheral vascular disease with severe claudication. OR,
6. Dementia with Mini Mental Status Exam score of 20 or less. OR,
7. Patients who received knee intra-articular corticosteroid injection within 4 weeks prior to the study or who received acupuncture treatment within 6 months. OR,
8. Unwilling to come off narcotic pain medication. OR,
9. History of bleeding diathesis or currently on anticoagulation. OR,
10. Patients currently engaged in medical legal cases related to OA or disability.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sham acupuncture	Acupuncture	Sham acupuncture
Real acupuncture	Acupuncture	Real acupuncture

Primary Outcome Measures

Name	Time	Method
Sleep disturbances as recorded by wrist actigraph, including sleep duration and sleep efficiency. Pain as measured by 0-10 VAS and WOMAC pain scores.	at least 3 months

Secondary Outcome Measures

Name	Time	Method
WOMAC disability scores, IDEEA gait patterns and activity levels, medication type and amount consumed, side effects, and medical care utilization.	at least 3 months

Trial Locations

Locations (1)

Wesley Woods Geriatric Hospital; 🇺🇸 Atlanta, Georgia, United States