Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Pain; Sleep
• Intervention / Treatment: Procedure: Acupuncture

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Wesley Woods Geriatric Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham acupuncture	Procedure: Acupuncture
Experimental: Real acupuncture	Procedure: Acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: The John A. Hartford Foundation; Southeast Center of Excellence in Geriatric Medicine
• Investigators: Principal Investigator: Wei Huang, MD, PhD, Emory University

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): April 1, 2008

Study Registration Dates

• First Submitted: June 6, 2008
• First Submitted That Met QC Criteria: June 9, 2008
• First Posted (Estimate): June 10, 2008

Study Record Updates

• Last Update Posted (Estimate): November 21, 2013
• Last Update Submitted That Met QC Criteria: November 19, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Dyssomnias; Parasomnias
• Other Study ID Numbers: IRB00000143; Grant #97333-G