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

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ClinicalTrials.gov Identifier: NCT00059345
Recruitment Status : Completed
First Posted : April 24, 2003
Last Update Posted : November 18, 2013
Sponsor:
Collaborators:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Acupuncture Procedure: Placebo acupuncture Other: Usual Care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 639 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Impact of Patient-Provider Interaction on Response to Acupuncture
Study Start Date : September 2002
Actual Primary Completion Date : July 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Sham acupuncture
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


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

Secondary Outcome Measures :
  1. SF-12 [ Time Frame: 3-month ]
  2. Range of motion of each knee [ Time Frame: 3-month ]
  3. Timed walking test [ Time Frame: 3-month ]
  4. Locus of control [ Time Frame: Baseline ]
  5. Optimism [ Time Frame: 3-month ]
  6. Self-efficacy [ Time Frame: baseline ]
  7. Cognitive pain [ Time Frame: 3-month ]
  8. Anxiety [ Time Frame: 3-month ]
  9. Social support [ Time Frame: 3-month ]
  10. Patient reaction [ Time Frame: 3-month ]
  11. Physician trust [ Time Frame: 3-month ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00059345


Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Maria E. Suarez-Almazor, MD, PhD M.D. Anderson Cancer Center
More Information
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Additional Information:

Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00059345    
Other Study ID Numbers: R01AR049999 ( U.S. NIH Grant/Contract )
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 )
First Posted: April 24, 2003    Key Record Dates
Last Update Posted: November 18, 2013
Last Verified: November 2013
Keywords provided by M.D. Anderson Cancer Center:
Acupuncture
Arthritis
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases