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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
639
Electroacupuncture treatments provided two times per week for 6 weeks
Placebo acupuncture treatments provided 2 times per week for 6 weeks
Usual care for knee osteoarthritis
Baylor College of Medicine
Houston, Texas, United States
University of Texas M. D. Anderson Cancer Center
Houston, Texas, United States
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale
Time frame: 3-month
Joint-Specific Multidimensional Assessment of Pain (J-MAP) to evaluate placebo effects on the different dimensions of pain
Time frame: 3-month
Patient satisfaction with their knee condition (SKIP)
Time frame: 3-month
SF-12
Time frame: 3-month
Range of motion of each knee
Time frame: 3-month
Timed walking test
Time frame: 3-month
Locus of control
Time frame: Baseline
Optimism
Time frame: 3-month
Self-efficacy
Time frame: baseline
Cognitive pain
Time frame: 3-month
Anxiety
Time frame: 3-month
Social support
Time frame: 3-month
Patient reaction
Time frame: 3-month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Physician trust
Time frame: 3-month