Interaction Between Patient and Healthcare Provider: Response to Acupuncture in Knee Osteoarthritis - Full Text View

Sponsors and Collaborators:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00059345

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	Intervention
Osteoarthritis	Procedure: Acupuncture Procedure: Placebo acupuncture Other: Usual Care

MedlinePlus related topics: Acupuncture Osteoarthritis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	The Impact of Patient-Provider Interaction on Response to Acupuncture

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale [ Time Frame: 3-month ] [ Designated as safety issue: No ]
Joint-Specific Multidimensional Assessment of Pain (J-MAP) to evaluate placebo effects on the different dimensions of pain [ Time Frame: 3-month ] [ Designated as safety issue: No ]
Patient satisfaction with their knee condition (SKIP) [ Time Frame: 3-month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

SF-12 [ Time Frame: 3-month ] [ Designated as safety issue: No ]
Range of motion of each knee [ Time Frame: 3-month ] [ Designated as safety issue: No ]
Timed walking test [ Time Frame: 3-month ] [ Designated as safety issue: No ]
Locus of control [ Time Frame: Baseline ] [ Designated as safety issue: No ]
Optimism [ Time Frame: 3-month ] [ Designated as safety issue: No ]
Self-efficacy [ Time Frame: baseline ] [ Designated as safety issue: No ]
Cognitive pain [ Time Frame: 3-month ] [ Designated as safety issue: No ]
Anxiety [ Time Frame: 3-month ] [ Designated as safety issue: No ]
Social support [ Time Frame: 3-month ] [ Designated as safety issue: No ]
Patient reaction [ Time Frame: 3-month ] [ Designated as safety issue: No ]
Physician trust [ Time Frame: 3-month ] [ Designated as safety issue: No ]

Enrollment:	639
Study Start Date:	September 2002
Study Completion Date:	August 2006
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Participants will receive acupuncture	Procedure: Acupuncture Electroacupuncture treatments provided two times per week for 6 weeks
2: Placebo Comparator Participants will receive shallow needling on non-mederian points	Procedure: Placebo acupuncture Placebo acupuncture treatments provided 2 times per week for 6 weeks
3 Participants will receive no acupuncture or placebo acupuncture treatment	Other: Usual Care Usual care for knee osteoarthritis

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059345

Locations

United States, Texas
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators

Principal Investigator:

Maria E. Suarez-Almazor, MD, PhD

M.D. Anderson Cancer Center

More Information

Responsible Party:	University of Texas M. D. Anderson Cancer Center ( Maria Suarez-Almazor, MD, PhD )
Study ID Numbers:	R01 AR49999, NIAMS-087
Study First Received:	April 23, 2003
Last Updated:	February 29, 2008
ClinicalTrials.gov Identifier:	NCT00059345
Health Authority:	United States: Federal Government

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

Acupuncture
Arthritis

Study placed in the following topic categories:

Osteoarthritis, Knee
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

ClinicalTrials.gov processed this record on January 16, 2009