NCT05417724

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 19, 2022

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
Last Updated

December 12, 2023

Status Verified

December 1, 2023

Enrollment Period

1.4 years

First QC Date

May 19, 2022

Last Update Submit

December 6, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Change in pain may impact behavioral health issues.

    4 months

  • Change in pain may impact housing stability

    4 months

  • Change in pain may impact substance use.

    4 months

Study Arms (1)

Battlefield Acupuncture

OTHER

All subjects will receive BFA treatment weekly for 12 weeks.

Other: Battlefield Acupuncture

Interventions

Battlefield Acupuncture

Battlefield Acupuncture

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bedford VA Healthcare System

Bedford, Massachusetts, 01730, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • John Wells, PhD

    Edith Nourse Rogers Memorial Veterans Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Recruitment of veterans with chronic pain who are interested in being treated with Battlefield Acupuncture (BFA).
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 19, 2022

First Posted

June 14, 2022

Study Start

March 28, 2022

Primary Completion

September 5, 2023

Study Completion

September 5, 2023

Last Updated

December 12, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

No plan to do this.

Locations