Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286390
Status:
COMPLETED
Last Update Posted:
2007-09-05
First Post:
2006-02-01
Brief Title:
Acupuncture for Acute and Chronic Pain in Air Force Personnel
Sponsor:
Samueli Institute for Information Biology
Organization:
Samueli Institute for Information Biology
Study Overview
Official Title:
Outcomes and Cost Assessment of Acupuncture in the Treatment OCAT of Pain Patients at Malcolm Grow USAF Medical Center
Status:
COMPLETED
Status Verified Date:
2007-09
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:
The purpose of this project is to conduct a scientifically rigorous investigation of the clinical outcomes quality of life and cost associated with the delivery of acupuncture in the treatment of acute and chronic pain in patients at Malcolm Grow Medical Center Andrews Air Force Base
The specific aims of this study are to
1 Gather outcomes and patient satisfaction data on patients receiving acupuncture treatment for acute and chronic pain
2 Perform an analysis of costs including any system cost savings associated with providing acupuncture services to pain patients
3 Serve as a model to expand the project to Scott AFB and Travis AFB as per the request of the Air Mobility Command Surgeon General AMCSG
The specific aims of this study are to
1 Gather outcomes and patient satisfaction data on patients receiving acupuncture treatment for acute and chronic pain
2 Perform an analysis of costs including any system cost savings associated with providing acupuncture services to pain patients
3 Serve as a model to expand the project to Scott AFB and Travis AFB as per the request of the Air Mobility Command Surgeon General AMCSG
Detailed Description:
Adult patients referred to the MGMC Acupuncture Clinic for this study must have an established Western medical diagnosis have exhausted all standards of care for the reduction andor resolution of pain meet the inclusion and exclusion criteria and be clinically evaluated prior to entry in the study 1000 patients will be entered into the study no male and female patient ratios will be required Patients under 18 years of age will be excluded There are no upper age limits
Acupuncture points selection and acupuncture techniques will be individualized for each patient All treatments will be approved by the physician principal investigator Treatment will generally be administered with the patient either prone supine or seated position Standards of reporting interventions in controlled trials of acupuncture based on STRICTA requirements will be followed The following acupuncture data will be collected
Acupuncture point locations palpation or electronic detection
Techniques employed eg dry needling acupuncture electro-acupuncture auriculotherapy electro-auriculotherapy laser piezo-electrical stimulation micro-current techniques E-field
Types of needles employed eg ASP goldstainless steel needle tacks Seirin needles etc
Baseline demographic data and information on pain levels using the Numerical Rating Scale patient satisfaction using the Patient Satisfaction Questionnaire functional health status using the SF-8 and concomitant medical care including medication use will be collected prior to treatment Follow-up data on pain levels and concomitant medical care will be collected via telephone 24 hours 1 week 2 weeks and 4 weeks post-therapy Patient satisfaction and functional health status data will be collecetd again at 4 weeks post-treatment Relapses of pain will be noted and appropriately evaluated In addition the following clinical data will be collected
Subjective Objective Assessment and TreatmentSOAP parameters
Medication use
Range of motion
A cost analysis will be performed by comparing patients who seek acupuncture treatment to those who receive only conventional medical care during the same time period by matching cohorts based on ICD-9 diagnostic codes and basic demographic information
A series of appropriate parametric and nonparametric tests will be performed to look for pre-post differences in patient outcomes on a number of relevant baseline variables including demographic information intensity and duration of pain SF-8 scores patient satisfaction and utilization of concomitant medical services
An ancillary study will be conducted to investigate personality factors and pretreatment expectations as predictors of treatment outcome of medical acupuncture Specific Aims of this ancillary study include
1 To assess perceived health outcomes after acupuncture treatment by military medical acupuncturists
2 To identify psychosocial and demographic predictors of perceived health outcomes from acupuncture treatment by military medical acupuncturists
3 To help clarify which patients are more likely to respond to acupuncture and hence more likely to benefit from a referral to a trained medical acupuncturist
Acupuncture points selection and acupuncture techniques will be individualized for each patient All treatments will be approved by the physician principal investigator Treatment will generally be administered with the patient either prone supine or seated position Standards of reporting interventions in controlled trials of acupuncture based on STRICTA requirements will be followed The following acupuncture data will be collected
Acupuncture point locations palpation or electronic detection
Techniques employed eg dry needling acupuncture electro-acupuncture auriculotherapy electro-auriculotherapy laser piezo-electrical stimulation micro-current techniques E-field
Types of needles employed eg ASP goldstainless steel needle tacks Seirin needles etc
Baseline demographic data and information on pain levels using the Numerical Rating Scale patient satisfaction using the Patient Satisfaction Questionnaire functional health status using the SF-8 and concomitant medical care including medication use will be collected prior to treatment Follow-up data on pain levels and concomitant medical care will be collected via telephone 24 hours 1 week 2 weeks and 4 weeks post-therapy Patient satisfaction and functional health status data will be collecetd again at 4 weeks post-treatment Relapses of pain will be noted and appropriately evaluated In addition the following clinical data will be collected
Subjective Objective Assessment and TreatmentSOAP parameters
Medication use
Range of motion
A cost analysis will be performed by comparing patients who seek acupuncture treatment to those who receive only conventional medical care during the same time period by matching cohorts based on ICD-9 diagnostic codes and basic demographic information
A series of appropriate parametric and nonparametric tests will be performed to look for pre-post differences in patient outcomes on a number of relevant baseline variables including demographic information intensity and duration of pain SF-8 scores patient satisfaction and utilization of concomitant medical services
An ancillary study will be conducted to investigate personality factors and pretreatment expectations as predictors of treatment outcome of medical acupuncture Specific Aims of this ancillary study include
1 To assess perceived health outcomes after acupuncture treatment by military medical acupuncturists
2 To identify psychosocial and demographic predictors of perceived health outcomes from acupuncture treatment by military medical acupuncturists
3 To help clarify which patients are more likely to respond to acupuncture and hence more likely to benefit from a referral to a trained medical acupuncturist
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 |
|---|---|---|---|
| FMG2005-0002H | None | None | None |