Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis

Pain Clinical Trial

Official title:

Exploring Outcomes and Mechanisms of Acupuncture in Treating Pain and Sleep Disturbance in Knee Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00694447
• Other study ID #: IRB00000143
• Secondary ID: Grant #97333-G
• Status: Completed
• Phase: N/A
• First received: June 6, 2008
• Last updated: November 19, 2013
• Start date: February 2007

Study information

• Verified date: November 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical 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).

• Main effects of acupuncture on sleep improvement and pain relief are anticipated when acupoints are separately targeted for sleep and for pain, respectively.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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

N/A

Related Conditions & MeSH terms

• Dyssomnias
• Osteoarthritis
• Osteoarthritis, Knee
• Pain
• Parasomnias
• Sleep
• Sleep Disorders

Intervention

Procedure:
• Acupuncture

Locations

Country	Name	City	State
United States	Wesley Woods Geriatric Hospital	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	Southeast Center of Excellence in Geriatric Medicine, The John A. Hartford Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	WOMAC disability scores, IDEEA gait patterns and activity levels, medication type and amount consumed, side effects, and medical care utilization.		at least 3 months	Yes

External Links

•   publication from this study