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

Further Study Details: 

Expected Total Enrollment:  760

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.

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

Criteria

Inclusion Criteria:

• OA diagnosis according to the American College of Rheumatology criteria
• Pain in the knee of at least 3 or more on a 0 to 10 scale (0 none, 10 extreme pain) within 2 weeks prior to study entry
• Stable treatment with anti-inflammatory and analgesic medications during the month prior to study entry
• If receiving glucosamine, stable dosage for 2 months prior to study entry
• Adequate cognitive status as determined by the study officials
• Living in the community
• Ability to communicate in English without a translator
• Access to a telephone

Exclusion Criteria:

• Other diagnosed joint diseases, such as rheumatoid arthritis
• Previous treatment with acupuncture (for any condition)
• Intra-articular injections in the knee in the 2 months prior to study entry

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

Study chairs or principal investigators

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

Study ID Numbers:  NIAMS-087; 1R01 AR49999-01
Record last reviewed:  March 2005
Last Updated:  March 18, 2005
Record first received:  April 23, 2003
ClinicalTrials.gov Identifier:  NCT00059345
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08