Back to resultsUtilizing Battlefield Acupuncture(BFA) to Treat Chronic Pain for Homeless and at Risk Veterans.
Primary Purpose
Acupuncture, Homelessness, Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Battlefield Acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Acupuncture
Eligibility Criteria
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.
Sites / Locations
- Bedford VA Healthcare SystemRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Battlefield Acupuncture
Arm Description
All subjects will receive BFA treatment weekly for 12 weeks.
Outcomes
Primary Outcome Measures
Reduction in pain
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
Change in pain may impact behavioral health issues.
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.
Change in pain may impact housing stability
Whether effective treatment for chronic pain has an impact on housing stability as measured by the housing stability questionnaire.
Change in pain may impact substance use.
Whether effective treatment for chronic pain has an impact on substance use as measured by the substance use questionnaire.
Full Information
NCT ID
NCT05417724
First Posted
May 19, 2022
Last Updated
June 9, 2022
Sponsor
Edith Nourse Rogers Memorial Veterans Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05417724
Brief Title
Utilizing Battlefield Acupuncture(BFA) to Treat Chronic Pain for Homeless and at Risk Veterans.
Official Title
Utilizing Battlefield Acupuncture(BFA) to Treat Chronic Pain for Homeless and at Risk Veterans.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 28, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Edith Nourse Rogers Memorial Veterans Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
4. Findings: Pending
5. 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.
6. Impact/Significance: Pending
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acupuncture, Homelessness, Pain, Veterans
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Recruitment of veterans with chronic pain who are interested in being treated with Battlefield Acupuncture (BFA).
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Battlefield Acupuncture
Arm Type
Other
Arm Description
All subjects will receive BFA treatment weekly for 12 weeks.
Intervention Type
Other
Intervention Name(s)
Battlefield Acupuncture
Intervention Description
Battlefield Acupuncture
Primary Outcome Measure Information:
Title
Reduction in pain
Description
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
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Change in pain may impact behavioral health issues.
Description
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.
Time Frame
4 months
Title
Change in pain may impact housing stability
Description
Whether effective treatment for chronic pain has an impact on housing stability as measured by the housing stability questionnaire.
Time Frame
4 months
Title
Change in pain may impact substance use.
Description
Whether effective treatment for chronic pain has an impact on substance use as measured by the substance use questionnaire.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cathy M St Pierre, PhD
Phone
781-687-2983
Email
Cathy.StPierre@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Alexandra Howard, BS
Phone
781-687-3162
Email
Alexandra.Howard@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Wells, PhD
Organizational Affiliation
Edith Nourse Rogers Memorial Veterans Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Bedford VA Healthcare System
City
Bedford
State/Province
Massachusetts
ZIP/Postal Code
01730
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cathy St Pierre, PhD,APRN
Phone
781-687-2983
Email
Cathy.StPierre@va.gov
First Name & Middle Initial & Last Name & Degree
Alexandra Howard, BS
Phone
781-687-3162
Email
Alexandra.Howard@va.gov
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to do this.
Learn more about this trial
Utilizing Battlefield Acupuncture(BFA) to Treat Chronic Pain for Homeless and at Risk Veterans.
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