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| ID | Type | Description | Link |
|---|---|---|---|
| R01AR049999 | U.S. NIH Grant/Contract | View source | |
| NIAMS-087 | Other Identifier | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | |
| 2006-0605 | Other Identifier | UT MDACC Study ID |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Acupuncture | Experimental | Participants will receive acupuncture |
|
| Arm 2: Shallow needling | Placebo Comparator | Participants will receive shallow needling on non-mederian points |
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| Arm 3: No Acupuncture or Placebo Treatment | Other | Participants will receive usual care, no acupuncture or placebo acupuncture treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture | Procedure | Electroacupuncture treatments provided two times per week for 6 weeks |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| SF-12 | 3-month | |
| Range of motion of each knee | 3-month | |
| Timed walking test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria E. Suarez-Almazor, MD, PhD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baylor College of Medicine | Houston | Texas | 77030 | United States | ||
| University of Texas M. D. Anderson Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20506122 | Result | 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. | |
| 22857778 | Derived | 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. |
| Label | URL |
|---|---|
| University of Texas (UT) MD Anderson Cancer Center Official Website | View source |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| D015671 | Electroacupuncture |
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D003131 | Combined Modality Therapy |
| D004599 | Electric Stimulation Therapy |
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| Placebo acupuncture | Procedure | Placebo acupuncture treatments provided 2 times per week for 6 weeks |
|
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| Usual Care | Other | Usual care for knee osteoarthritis |
|
| 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 |
| Houston |
| Texas |
| 77030 |
| United States |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
| D000758 | Anesthesia |