Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis

This study has been completed.
Sponsor:
Collaborators:
Southeast Center of Excellence in Geriatric Medicine
The John A. Hartford Foundation
Information provided by (Responsible Party):
Wei Huang MD, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00694447
First received: June 6, 2008
Last updated: November 19, 2013
Last verified: November 2013
  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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: June 6, 2008
Last Updated: November 19, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 19, 2014