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Interaction Between Patient and Healthcare Provider: Response to Acupuncture in Knee Osteoarthritis
This study has been completed.
Study NCT00059345   Information provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First Received: April 23, 2003   Last Updated: February 29, 2008   History of Changes

April 23, 2003
February 29, 2008
September 2002
July 2006   (final data collection date for primary outcome measure)
  • 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 ]
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale
  • Joint-Specific Multidimensional Assessment of Pain (J-MAP) to evaluate placebo effects on the different dimensions of pain
  • patient satisfaction with their knee condition (SKIP)
Complete list of historical versions of study NCT00059345 on ClinicalTrials.gov Archive Site
  • 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 ]
  • SF-12
  • range of motion of each knee
  • timed walking test
  • locus of control
  • perceived stress
  • optimism
  • self-efficacy
  • cognitive pain
  • anxiety
  • social support
  • patient reaction
  • physician trust
 
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.

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.

 
Interventional
Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study
Osteoarthritis
  • Procedure: Acupuncture
  • Procedure: Placebo acupuncture
  • Other: Usual Care
  • Experimental: Participants will receive acupuncture
  • Placebo Comparator: Participants will receive shallow needling on non-mederian points
  • Other: Participants will receive no acupuncture or placebo acupuncture treatment
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
639
August 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00059345
Maria Suarez-Almazor, MD, PhD, University of Texas M. D. Anderson Cancer Center
R01 AR49999, NIAMS-087
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Center for Complementary and Alternative Medicine (NCCAM)
Principal Investigator: Maria E. Suarez-Almazor, MD, PhD M.D. Anderson Cancer Center
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP