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Acupuncture for Acute and Chronic Pain in Air Force Personnel

4. september 2007 opdateret af: Samueli Institute for Information Biology

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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Maryland
      • Andrews AFB, Maryland, Forenede Stater, 20762
        • Malcolm Grow Medical Center (MGMC), Andrews Air Force Base

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Western diagnosis of acute or chronic pain syndromes
  • Previously treated western standard of care
  • Written Informed Consent
  • Over the age of 18

Exclusion Criteria:

  • Unwilling or unable to participate in study treatment and follow-up
  • Unable to give informed consent for any reason
  • Allergic reaction to adhesive tape, gold or other components of the acupuncture needles
  • Pregnancy
  • Pacemaker
  • Electronic stimulator of any sort
  • Herbal preparations

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Faktoriel opgave
  • Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Level of Pain at Conclusion of Study, as measured by using a 0-10 Numerical Rating Scale (NRS)
Tidsramme: Baseline; Final assessment
Baseline; Final assessment

Sekundære resultatmål

Resultatmål
Tidsramme
Pain Level, as measured by using a 0-10 Numerical Rating Scale (NRS) and Medication Use
Tidsramme: Baseline; Immediately after tx; 24 hours after tx
Baseline; Immediately after tx; 24 hours after tx

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: COL Richard C Niemtzow, MD, PhD, MPH, United States Air Force

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2005

Studieafslutning (Faktiske)

1. februar 2006

Datoer for studieregistrering

Først indsendt

1. februar 2006

Først indsendt, der opfyldte QC-kriterier

1. februar 2006

Først opslået (Skøn)

3. februar 2006

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

5. september 2007

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. september 2007

Sidst verificeret

1. september 2007

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CRO-04-01
  • FMG2005-0002H

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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