Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059345
Status:
COMPLETED
Last Update Posted:
2013-11-18
First Post:
2003-04-23
Brief Title:
Interaction Between Patient and Healthcare Provider Response to Acupuncture in Knee Osteoarthritis
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
The Impact of Patient-Provider Interaction on Response to Acupuncture
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Interactions between patients and healthcare providers may have a significant impact on a patients 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 patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-0605 | OTHER | UT MDACC Study ID | httpsreporternihgovquickSearchR01AR049999 |
| R01AR049999 | NIH | None | None |
| NIAMS-087 | OTHER | None | None |