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Completed

NCT Number: NCT05417724

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.

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Key information

Conditions

Acupuncture Homelessness Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Veterans

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bedford VA Healthcare System

Bedford, Massachusetts, 01730, United States

About this study

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.

  • Findings: Pending
  • 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.
  • Impact/Significance: Pending

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Battlefield Acupuncture

Other

Battlefield Acupuncture

Primary outcomes

  1. Reduction in pain

    Time frame: 4 months

    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.

Secondary outcomes

  1. Change in pain may impact behavioral health issues.

    Time frame: 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 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.

  2. Change in pain may impact housing stability

    Time frame: 4 months

    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

  3. Change in pain may impact substance use.

    Time frame: 4 months

    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.

Sponsors and collaborators

Lead sponsor

Edith Nourse Rogers Memorial Veterans Hospital

Fed

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 14, 2022
Registry last updated
Dec 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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