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

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00059345
First received: April 23, 2003
Last updated: November 15, 2013
Last verified: November 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: The Impact of Patient-Provider Interaction on Response to Acupuncture

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Maria E. Suarez-Almazor, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00059345     History of Changes
Other Study ID Numbers: R01 AR49999, R01AR049999, NIAMS-087, 2006-0605
Study First Received: April 23, 2003
Last Updated: November 15, 2013
Health Authority: United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
Acupuncture
Arthritis

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 14, 2014