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The Impact of Patient-Provider Interaction on Response to Acupuncture

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Trial Information

The Impact of Patient-Provider Interaction on Response to Acupuncture

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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale

Outcome Time Frame:


Safety Issue:


Principal Investigator

Maria E. Suarez-Almazor, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Federal Government

Study ID:

R01 AR49999



Start Date:

September 2002

Completion Date:

August 2006

Related Keywords:

  • Osteoarthritis
  • Acupuncture
  • Arthritis
  • Osteoarthritis
  • Osteoarthritis, Knee



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