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Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00694447
First Posted: June 10, 2008
Last Update Posted: November 21, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Southeast Center of Excellence in Geriatric Medicine
The John A. Hartford Foundation
Information provided by (Responsible Party):
Wei Huang MD, PhD, Emory University
  Purpose

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.

Condition Intervention
Sleep Pain Procedure: Acupuncture

Study Type: Interventional
Official Title: Exploring Outcomes and Mechanisms of Acupuncture in Treating Pain and Sleep Disturbance in Knee Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Wei Huang MD, PhD, Emory University:

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. [ Time Frame: at least 3 months ]

Secondary Outcome Measures:
  • 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 ]

Study Start Date: February 2007
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Real acupuncture
Real acupuncture
Procedure: Acupuncture
Sham Comparator: Sham acupuncture
Sham acupuncture
Procedure: Acupuncture

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00694447


Locations
United States, Georgia
Wesley Woods Geriatric Hospital
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
Emory University
Southeast Center of Excellence in Geriatric Medicine
The John A. Hartford Foundation
Investigators
Principal Investigator: Wei Huang, MD, PhD Emory University
  More Information

Additional Information:
Responsible Party: Wei Huang MD, PhD, Principal Investigator, Emory University
ClinicalTrials.gov Identifier: NCT00694447     History of Changes
Other Study ID Numbers: IRB00000143
Grant #97333-G
First Submitted: June 6, 2008
First Posted: June 10, 2008
Last Update Posted: November 21, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Dyssomnias
Sleep Wake Disorders
Parasomnias
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms