Clinical trial NCT00059345: Interaction Between Patient and Healthcare Provider: Response to Acupuncture in Knee Osteoarthritis
Official title: The Impact of Patient-Provider Interaction on Response to Acupuncture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Acupuncture
Arthritis
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2003-04-24
Enrollment: 639
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale
timeFrame: 3-month
measure: Joint-Specific Multidimensional Assessment of Pain (J-MAP) to evaluate placebo effects on the different dimensions of pain
timeFrame: 3-month
measure: Patient satisfaction with their knee condition (SKIP)
timeFrame: 3-month
Secondary outcomes:
measure: SF-12
timeFrame: 3-month
measure: Range of motion of each knee
timeFrame: 3-month
measure: Timed walking test
timeFrame: 3-month
measure: Locus of control
timeFrame: Baseline
measure: Optimism
timeFrame: 3-month
measure: Self-efficacy
timeFrame: baseline
measure: Cognitive pain
timeFrame: 3-month
measure: Anxiety
timeFrame: 3-month
measure: Social support
timeFrame: 3-month
measure: Patient reaction
timeFrame: 3-month
measure: Physician trust
timeFrame: 3-month
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: University of Texas M. D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Maria E. Suarez-Almazor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Suarez-Almazor ME, Looney C, Liu Y, Cox V, Pietz K, Marcus DM, Street RL Jr. A randomized controlled trial of acupuncture for osteoarthritis of the knee: effects of patient-provider communication. Arthritis Care Res (Hoboken). 2010 Sep;62(9):1229-36. doi: 10.1002/acr.20225.
citation: Street RL Jr, Cox V, Kallen MA, Suarez-Almazor ME. Exploring communication pathways to better health: clinician communication of expectations for acupuncture effectiveness. Patient Educ Couns. 2012 Nov;89(2):245-51. doi: 10.1016/j.pec.2012.06.032. Epub 2012 Jul 31.