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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Acupuncture; Homelessness; Veterans
• Intervention / Treatment: Other: Battlefield Acupuncture

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

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Bedford, Massachusetts, United States, 01730
      • Bedford VA Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Battlefield Acupuncture; All subjects will receive BFA treatment weekly for 12 weeks.	Other: Battlefield Acupuncture; Battlefield Acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in pain	Whether the use of BFA on veterans with chronic pain will decrease pain. Questionnaire. The pain scale is based on 0-10 with a higher score indicating an increase in pain and the lower score indicating a decrease in pain level.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 based on a numerical score from 0-4. This questionnaire is broken down into 4 questions- 2 focused on anxiety and two questions focused on depressions. Each question has a likert scale to select a number from 0-3. The higher the number, the higher the level of anxiety/depression. The cumulative score is based on a score of 0-12, with the higher scores indicating higher psychological distress.	4 months
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. this questionnaire asks questions about the number of nites in the past 30 days, a research subject has spent in a variety of settings. The scale is 0-30 with the higher the number, the more transient the person's current living situation. The purpose is to see if a change in pain levels will impact the number of nights in transitional housing. The higher the pain level an positively/negatively impact the numbers of nite in transitional housing	4 months
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. This questionnaire asked each subject to identify the number of drinks/drugs that the subject has consumed in the past 30 days.	4 months

Collaborators and Investigators

• Sponsor: Edith Nourse Rogers Memorial Veterans Hospital
• Investigators: Study Chair: John Wells, PhD, Edith Nourse Rogers Memorial Veterans Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Actual): September 5, 2023
• Study Completion (Actual): September 5, 2023

Study Registration Dates

• First Submitted: May 19, 2022
• First Submitted That Met QC Criteria: June 9, 2022
• First Posted (Actual): June 14, 2022

Study Record Updates

• Last Update Posted (Actual): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 1645513

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to do this.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No