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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05417724
• Other study ID #: 1645513
• Status: Completed
• Phase: N/A
• Start date: March 28, 2022
• Est. completion date: September 5, 2023

Study information

• Verified date: December 2023
• Source: Edith Nourse Rogers Memorial Veterans Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 5, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acupuncture
• Chronic Pain
• Homelessness
• Pain
• Veterans

Intervention

Other:
• Battlefield Acupuncture
Battlefield Acupuncture

Locations

Country	Name	City	State
United States	Bedford VA Healthcare System	Bedford	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Edith Nourse Rogers Memorial Veterans Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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