Acute Pain Clinical Trial
Official title:
Outcomes and Cost Assessment of Acupuncture in the Treatment (OCAT) of Pain Patients at Malcolm Grow USAF Medical Center
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. (AMC/SG).
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 and/or 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 point(s) 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: (e.g. dry needling, acupuncture, electro-acupuncture ,
auriculotherapy, electro-auriculotherapy, laser, piezo-electrical stimulation
micro-current techniques, E-field)
- Types of needles employed (e.g. ASP gold/stainless 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 Treatment(SOAP) 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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