Acupuncture for Pain and Sleep Disturbance in Knee Osteoarthritis

NCT ID: NCT00694447

Last Updated: 2013-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep Pain

Study Groups

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Real acupuncture

Real acupuncture

Group Type EXPERIMENTAL

Acupuncture

Intervention Type PROCEDURE

Sham acupuncture

Sham acupuncture

Group Type SHAM_COMPARATOR

Acupuncture

Intervention Type PROCEDURE

Interventions

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Acupuncture

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southeast Center of Excellence in Geriatric Medicine

UNKNOWN

Sponsor Role collaborator

The John A. Hartford Foundation

OTHER

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Wei Huang MD, PhD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wei Huang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Wesley Woods Geriatric Hospital

Atlanta, Georgia, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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Grant #97333-G

Identifier Type: -

Identifier Source: secondary_id

IRB00000143

Identifier Type: -

Identifier Source: org_study_id