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Interaction Between Patient and Healthcare Provider: Response to Acupuncture in Knee Osteoarthritis

This study is currently recruiting patients.

Sponsored by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Purpose

Interactions between patients and healthcare providers may have a significant impact on a patient's response to therapy. In this study, patients with osteoarthritis (OA) of the knee will receive either acupuncture or sham acupuncture. The acupuncturists will be trained to interact with the patients in specific ways. The study will evaluate those interactions.

Condition Treatment or Intervention Phase
Osteoarthritis
 Procedure: Acupuncture
Phase III

MedlinePlus related topics:  Osteoarthritis

Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title: The Impact of Patient-Provider Interaction on Response to Acupuncture

Further Study Details: 

Expected Total Enrollment:  760

Study start: September 2002;  Study completion: August 2006

This study will examine placebo responses in the context of practitioner-patient interactions at the time of the encounter. Phase 1 of this study identified patient-related determinants of placebo response, such as beliefs and expectations toward treatment of knee OA with acupuncture. Phase 2 of the study evaluated an assessment tool to measure these determinants. Phase 3 of the study is a randomized controlled trial to evaluate whether placebo effects in patients with knee OA can be enhanced by the acupuncturists’ communicative style, which can affect a patient’s cognitive expectancies and beliefs.

Patients will initially be randomized to one of two groups, each with a different model for practitioner-patient interaction. Acupuncture practitioners will be trained to follow semi-structured communicative styles, including traditional approaches in Chinese medicine and techniques previously described in patient-doctor communications studies. Within each of these groups, patients will be further randomized to receive either acupuncture or sham acupuncture. Patients will have 6 weeks of biweekly treatment visits. Patients will be followed for 6 months. Visits will be weekly during the first 6 weeks of the study and monthly thereafter.

The study will also include a natural cohort group composed of patients on a study waiting list; these patients will be offered acupuncture 3 months after study entry.

Eligibility

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

Exclusion Criteria:


Location and Contact Information

Carol Looney, MS      713-794-8563    clooney@bcm.tmc.edu

Texas
      Houston Center for Quality of Care and Utilization Studies, Baylor College of Medicine, Houston,  Texas,  77030,  United States; Recruiting
Maria E. Suarez-Almazor, MD, PhD  713-794-8628    mes@bcm.tmc.edu 
Carol Looney, MS  713-794-8563    clooney@bcm.tmc.edu 
Maria E. Suarez-Almazor, MD, PhD,  Principal Investigator

Study chairs or principal investigators

Maria E. Suarez-Almazor, MD, PhD,  Principal Investigator,  Baylor College of Medicine   

More Information

Study ID Numbers:  NIAMS-087; 1R01 AR49999-01
Record last reviewed:  September 2004
Record first received:  April 23, 2003
ClinicalTrials.gov Identifier:  NCT00059345
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08
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