Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis

NCT00694447 | Completed

• 2 other identifiers: IRB00000143Grant #97333-G
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• WOMAC disability scores, IDEEA gait patterns and activity levels, medication type and amount consumed, side effects, and medical care utilization.

  at least 3 months

Study Arms (2)

Real acupuncture

EXPERIMENTAL

Real acupuncture

Procedure: Acupuncture

Sham acupuncture

SHAM COMPARATOR

Sham acupuncture

Procedure: Acupuncture

Interventions

Acupuncture PROCEDURE

Real acupuncture; Sham acupuncture

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[36\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• Southeast Center of Excellence in Geriatric Medicine: collaborator
• The John A. Hartford Foundation: collaborator

Study Sites (1)

Wesley Woods Geriatric Hospital

Atlanta, Georgia, 30329, United States

Location

Related Links

• publication from this study

MeSH Terms

Conditions

Pain

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Wei Huang, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 6, 2008
• First Posted: June 10, 2008
• Study Start: February 1, 2007
• Primary Completion: April 1, 2008
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

US (1)