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

The Impact of Patient-Provider Interaction on Response to Acupuncture

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Acupuncture; Procedure: Placebo acupuncture; Other: Usual Care

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 Type: Interventional
• Enrollment (Actual): 639
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77030
      • University of Texas M. D. Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Acupuncture; Participants will receive acupuncture	Procedure: Acupuncture; Electroacupuncture treatments provided two times per week for 6 weeks; Other Names: Electroacupuncture; TENS
Placebo Comparator: Arm 2: Shallow needling; Participants will receive shallow needling on non-mederian points	Procedure: Placebo acupuncture; Placebo acupuncture treatments provided 2 times per week for 6 weeks; Other Names: Sham acupuncture
Other: Arm 3: No Acupuncture or Placebo Treatment; Participants will receive usual care, no acupuncture or placebo acupuncture treatment.	Other: Usual Care; Usual care for knee osteoarthritis

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Maria E. Suarez-Almazor, MD, PhD, M.D. Anderson Cancer Center

Publications and helpful links

General Publications

• Suarez-Almazor ME, Looney C, Liu Y, Cox V, Pietz K, Marcus DM, Street RL Jr. A randomized controlled trial of acupuncture for osteoarthritis of the knee: effects of patient-provider communication. Arthritis Care Res (Hoboken). 2010 Sep;62(9):1229-36. doi: 10.1002/acr.20225.
• Street RL Jr, Cox V, Kallen MA, Suarez-Almazor ME. Exploring communication pathways to better health: clinician communication of expectations for acupuncture effectiveness. Patient Educ Couns. 2012 Nov;89(2):245-51. doi: 10.1016/j.pec.2012.06.032. Epub 2012 Jul 31.

Helpful Links

• University of Texas (UT) MD Anderson Cancer Center Official Website

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Actual): July 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: April 23, 2003
• First Submitted That Met QC Criteria: April 23, 2003
• First Posted (Estimate): April 24, 2003

Study Record Updates

• Last Update Posted (Estimate): November 18, 2013
• Last Update Submitted That Met QC Criteria: November 15, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Arthritis; Acupuncture
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: R01AR049999 (U.S. NIH Grant/Contract); NIAMS-087 (Other Identifier: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)); 2006-0605 (Other Identifier: UT MDACC Study ID)