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Study Summary
No. 2006-0605:.......Pain......Maria Suarez-Almazor......General Internal Medicine/Ambulatory Treatment & Emergency Care
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Study Summary Title
Study Summary
Number:		2006-0605
Study Title:Impact of Patient-Provider Interaction on the Response to Acupuncture
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Physician New Patient Referral
Name:Maria Suarez-AlmazorPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:General Internal Medicine/Ambulatory Treatment & Emergency CareReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-6486
Contact us about clinical trials
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General Information
Disease Group:PainSupported By:N/A
Phase of Study:Phase IIIReturn
Visit:		NA
Treatment
Agents:		AcupunctureHome Care:NA
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		NA
Description/
Intervention:		Unavailable
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Study Objectives / Outcomes
This is an on-going protocol that is transferring from Baylor College of Medicine with the Principal Investigator to UTMDACC. There are only 2 months of funding remaining (up to August 31 2006), and we have requested a one-year no cost extension to complete analysis and manuscript preparation. Patient enrollment is complete and closed. All data collection is complete. The focus of the protocol at UTMDACC will be analysis and publishing of the data. Dr. Suarez-Almazor will be overseeing the data analysis, summarizing results, reaching conclusions and paly a primary role in manuscript development and dissemination of research findings. This is an R01 which is also listed under Dr. Suarez-Almazor's Mentoring Career Award, K-24 (2006-0627). Please note there is no funding for this project from the K-24 award which only funds Dr. Suarez-Almazor's mentoring activities.

Primary Objectives:
Phase 3: 1.1 To describe and quantify placebo responses in patients with knee OA receiving a placebo intervention (sham acupuncture).
          1.2 To identify psychosocial and cognitive determinants of the placebo response in knee osteoarthritis (OA).
          1.3 To examine the effects of specific practitioner-patient interaction components on expectancies, patient outcomes and placebo responses
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Secondary Objectives - To evaluate the efficacy of acupuncture in patients with knee OA. This is not a primary aim of this proposal, since we are mostly interested in the effects of practitioner behaviors on the placebo response. Nevertheless, the data will allow us to test the hypothesis that acupuncture is effective in the treatment of knee OA.
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Study Status Information
Study Activation / Registration Date:08/08/2006
IRB Review and Approval Date:08/01/2006
Study Type:Phase Iii
Recruitment Status:Closed
Projected Accrual:560
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Osteoarthritis diagnosis according to the American College of Rheumatology criteria

2) Pain in the knee in the preceding two weeks of at least 3 or more on a 0 to 10 scale (0 none, 10 extreme pain)

3) No previous treatment with acupuncture (for any condition)

4) Stable treatment with anti-inflammatory and analgesic medications during the previous month

5) If receiving glucosamine, stable dosage for the past 2 months

6) No intraarticular injections in the knee in the previous 2 months

7) Adequate cognitive status as determined by the research assistant – If in doubt, Folstein's Mini Mental Status questionnaire will be used PLEASE NOTE: Use of Mini Mental Status questionnaire was not necessary or used with any patients screened or enrolled for this study. Therefore, the questionnaire is not attached for review. It was not used.

8) 50 years of age or older
Exclusion Criteria:1) Other diagnosed joint diseases such inflammatory arthropathies (e.g. rheumatoid arthritis)

2) Neurological disorders

3) Paget's syndrome or metabolic bone disorders

4) Severe uncontrolled comorbidities

5) Treatment with anticoagulants or history of a bleeding disorder

6) Seeking or receiving workers' compensation benefits
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Links
Registration Number: NCT00059345
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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