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

Not Applicable

Completed

• Conditions: Osteoarthritis
• Interventions: Procedure: Acupuncture; Procedure: Placebo acupuncture; Other: Usual Care

• Registration Number: NCT00059345
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2002-09
• Study First Submitted: 2003-04-23
• Study First Submitted QC: 2003-04-23
• Study First Posted: 2003-04-24
• Primary Completion: 2006-07
• Study Completion: 2006-08
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-15
• Last Update Posted: 2013-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 639

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1: Acupuncture	Acupuncture	Participants will receive acupuncture
Arm 2: Shallow needling	Placebo acupuncture	Participants will receive shallow needling on non-mederian points
Arm 3: No Acupuncture or Placebo Treatment	Usual Care	Participants will receive usual care, no acupuncture or placebo acupuncture treatment.

Primary Outcome Measures

Name	Time	Method
Joint-Specific Multidimensional Assessment of Pain (J-MAP) to evaluate placebo effects on the different dimensions of pain	3-month
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale	3-month
Patient satisfaction with their knee condition (SKIP)	3-month

Secondary Outcome Measures

Name	Time	Method
Optimism	3-month
Cognitive pain	3-month
SF-12	3-month
Timed walking test	3-month
Locus of control	Baseline
Self-efficacy	baseline
Patient reaction	3-month
Range of motion of each knee	3-month
Social support	3-month
Physician trust	3-month
Anxiety	3-month

Trial Locations

Locations (2)

University of Texas M. D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States