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

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Impact of Patient-Provider Interaction on Response to Acupuncture

Conditions
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Osteoarthritis

Intervention / Treatment
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* Procedure: Acupuncture
* Procedure: Placebo acupuncture
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Acupuncture<br>Participants will receive acupuncture | Procedure: Acupuncture<br>* Electroacupuncture treatments provided two times per week for 6 weeks<br>* Other names: TENS;|
| Placebo Comparator: Arm 2: Shallow needling<br>Participants will receive shallow needling on non-mederian points | Procedure: Placebo acupuncture<br>* Placebo acupuncture treatments provided 2 times per week for 6 weeks<br>* Other names: Sham acupuncture;|
| Other: Arm 3: No Acupuncture or Placebo Treatment<br>Participants will receive usual care, no acupuncture or placebo acupuncture treatment. | Other: Usual Care<br>* Usual care for knee osteoarthritis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale |  | 3-month | 
| Joint-Specific Multidimensional Assessment of Pain (J-MAP) to evaluate placebo effects on the different dimensions of pain |  | 3-month | 
| Patient satisfaction with their knee condition (SKIP) |  | 3-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-12 |  | 3-month | 
| Range of motion of each knee |  | 3-month | 
| Timed walking test |  | 3-month | 
| Locus of control |  | Baseline | 
| Optimism |  | 3-month | 
| Self-efficacy |  | baseline | 
| Cognitive pain |  | 3-month | 
| Anxiety |  | 3-month | 
| Social support |  | 3-month | 
| Patient reaction |  | 3-month | 
| Physician trust |  | 3-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Arthritis