Utilizing Battlefield Acupuncture(BFA) to Treat Chronic Pain for Homeless and at Risk Veterans.

Sponsor
Edith Nourse Rogers Memorial Veterans Hospital (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT05417724
Collaborator
(none)
35
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24.1
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Study Details

Study Description

Brief Summary

This research study will evaluate the effectiveness of utilizing Battlefield Acupuncture (BFA) on homeless and at risk for homelessness veterans with chronic pain for 12 weeks.

Condition or Disease Intervention/Treatment Phase
  • Other: Battlefield Acupuncture
N/A

Detailed Description

Methodology: This is a mixed methods prospective design study. A total of 35 subjects will be recruited for this study. The primary study outcome variables are: pain level- pre and post treatment, stress, mood and usual activity levels, sleep patterns and behavioral factors such as ; anxiety, depression, suicidal ideation, substance use and housing stability.

  1. Findings: Pending

  2. Clinical Relationships: This study is conducted to demonstrate whether or not BFA treatment will decrease pain and improve quality of life for homeless and at risk for homelessness veterans.

  3. Impact/Significance: Pending

Study Design

Study Type:
Interventional
Anticipated Enrollment :
35 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Recruitment of veterans with chronic pain who are interested in being treated with Battlefield Acupuncture (BFA).Recruitment of veterans with chronic pain who are interested in being treated with Battlefield Acupuncture (BFA).
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Utilizing Battlefield Acupuncture(BFA) to Treat Chronic Pain for Homeless and at Risk Veterans.
Actual Study Start Date :
Mar 28, 2022
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Battlefield Acupuncture

All subjects will receive BFA treatment weekly for 12 weeks.

Other: Battlefield Acupuncture
Battlefield Acupuncture

Outcome Measures

Primary Outcome Measures

  1. Reduction in pain [4 months]

    Whether the use of BFA on veterans with chronic pain will decrease pain and improve quality of life. Pain levels will be measured by changes in responses to the Acupuncture Questionnaire

Secondary Outcome Measures

  1. Change in pain may impact behavioral health issues. [4 months]

    Whether effective treatment for chronic pain has an impact on behavioral health issues. Patient Health Questionnaire (PHQ-4) will measure changes in anxiety and depression.

  2. Change in pain may impact housing stability [4 months]

    Whether effective treatment for chronic pain has an impact on housing stability as measured by the housing stability questionnaire.

  3. Change in pain may impact substance use. [4 months]

    Whether effective treatment for chronic pain has an impact on substance use as measured by the substance use questionnaire.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
Eligibility criteria include:
  • they are 18 years or older

  • they are homeless or at risk for homelessness veterans who are enrolled in the VA Bedford Healthcare system and registered in one of the HUD-VASH or HCHV programs,

  • history of chronic pain.

  • Availability to participate in the study for 4 months.

If they meet these criteria, they will be asked to complete the Informed consent to enroll in the study.

Exclusion Criteria:
  • female veterans who are pregnant

  • history of bleeding disorders or currently on blood thinning medications

  • currently being treated for an active infection of the outer ear.

  • currently have a PICC line in their body or are receiving IV antibiotics.

  • fear of needles/tacks

  • undiagnosed pain complaint

Our recruitment plan invites all eligible veterans and is just, fair, and equitable.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bedford VA Healthcare System Bedford Massachusetts United States 01730

Sponsors and Collaborators

  • Edith Nourse Rogers Memorial Veterans Hospital

Investigators

  • Study Chair: John Wells, PhD, VA Bedford Healthcare System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cathy St. Pierre, Principal Investigator, Edith Nourse Rogers Memorial Veterans Hospital
ClinicalTrials.gov Identifier:
NCT05417724
Other Study ID Numbers:
  • 1645513
First Posted:
Jun 14, 2022
Last Update Posted:
Jun 14, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 14, 2022