NCT06128772

Brief Summary

This research study will evaluate the effectiveness of utilizing Battlefield Acupuncture (BFA) on veterans with with a history of substance use disorder and chronic pain for 8 weeks. Primary Aim: The primary aim of this study is to evaluate the effectiveness of using BFA to treat chronic pain in veterans with a history of substance use disorder. Secondary Aim: This study will also evaluate the impact that BFA treatment for pain may have on subjects' stress, mood and sleep patterns over 8 weeks. In addition, each subject will be complete behavioral research tools to measure: depression, anxiety, and substance use at 3 different points in this study. Hypothesis: The use of BFA on veterans with chronic pain will decrease their pain and substance use and improve their quality of life.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P75+ for not_applicable chronic-pain

Timeline
8mo left

Started Dec 2023

Longer than P75 for not_applicable chronic-pain

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress78%
Dec 2023Dec 2026

First Submitted

Initial submission to the registry

October 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 13, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

December 30, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Expected
Last Updated

August 28, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

October 31, 2023

Last Update Submit

August 26, 2024

Conditions

Chronic PainSubstance Use Disorders

Keywords

Veteranschronic painSubstance Use HistoryBattlefield Acupuncture

Outcome Measures

Primary Outcomes (1)

  • Acupuncture questionnaire evaluating chronic pain levels

    Chronic pain level questionnaire ( Acupuncture questionnaire consists of X questions regarding pain. Patients select the level of pain from 0-10 ( the higher the number, the higher the pain. The scale range would be = (0-60).

    8 weeks of treatment, 8 weeks of post treatment follow-up

Secondary Outcomes (3)

  • Acupuncture Follow up Questionnaire which also evaluates the impact that BFA treatment for pain may have on subjects' stress, mood and sleep patterns over 8 weeks.

    8 weeks of treatment and 8 weeks of follow up

  • PHQ-4

    monthly for 16 weeks

  • Substance Use Questionnaire-

    monthly for 16 weeks

Study Arms (2)

Waitlist control

OTHER

Eight weeks of waitlist control and then 8 weeks of weekly treatment

Other: Battlefield Acupuncture

Immediate treatment

OTHER

Eight weeks of weekly treatment and then eight weeks of follow up

Other: Battlefield Acupuncture

Interventions

Battlefield AcupunctureOTHER

5 points of acupuncture treatment in each ear weekly for 8 weeks

Immediate treatmentWaitlist control

Eligibility Criteria

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

You may qualify if:

  • they are 18 years or older
  • they have a history of substance use disorder,
  • history of chronic pain
  • availability to participate in the study for 16 weeks.

You may not qualify if:

  • female veterans who are pregnant.
  • history of bleeding disorders or currently on older blood thinning medications that cause excessive bleeding.
  • currently being treated for an active infection of the outer ear (relative contraindication). -- currently have a PICC line in their body or are receiving IV antibiotics.
  • fear of needles/tacks, and/or
  • undiagnosed pain complaint

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bedford VA Healthcare System

Bedford, Massachusetts, 01730, United States

RECRUITING

MeSH Terms

Conditions

Chronic PainSubstance-Related Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsChemically-Induced DisordersMental Disorders

Central Study Contacts

Cathy M St Pierre, PhD

CONTACT

781-687-2983Cathy.StPierre@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 31, 2023

First Posted

November 13, 2023

Study Start

December 30, 2023

Primary Completion

December 30, 2025

Study Completion (Estimated)

December 30, 2026

Last Updated

August 28, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)