Utilizing Battlefield Acupuncture to Treat Chronic Pain

A Randomized Clinical Trial Utilizing Battlefield Acupuncture to Treat Chronic Pain in Veterans With a History of Substance Use Disorder.

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Substance Use Disorders
• Intervention / Treatment: Other: Battlefield Acupuncture

Detailed Description

Objective(s): 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.

2. Research Design: This is a prospective, RCT trial research study recruiting veterans with a history of chronic pain and substance use disorder.

3.3 Study Procedures

1. Sub-Study Participation- N/A.

2. Study A sample of veterans with chronic pain and substance use disorder will be recruited through distribution of flyers, live or virtual presentations, regarding this study.

   Interested veterans will attend an overview/orientation of this study. Recruited subjects will be given an informed consent (IFC) to read and sign. After completion of IFC the initial research packet will be given to complete and return to the research team.

   Once enrolled, each subject will be assigned to a wait list control of 8 weeks or active treatment for 8 weeks.

   Those in active treatment will be given a 15-20 minute appointment treatment time for the duration of 8 weeks.

   At each appointment, the subject will complete the BFA Questionnaire and other measures, prior to BFA treatment. Prior to treatment, the PI will briefly review subjects questionnaires and answer any questions. The PI will then provide the treatment.

   Treatment with BFA will include placing up to 5 BFA tacks in each ear, for a total of 10 per treatment. Each subject will provide a pain score in the following sequence: pre-treatment, after 3 BFA needles are placed in each ear and again, after the last 2 needles are placed.

   Post treatment instructions will be reviewed and PI will answer any questions. At the completion of the clinic, a note will be recorded in each subject's chart.

   All completed questionnaires will be kept in a locked file cabinet in the PI's locked office. Data will be coded and analyzed at a later time.

   There are no other examinations included for this study. A member of the research team will code each visit and transcribe de-identified data into a codebook.

   3. Methodology: This is a RCT design study. A total of 60 subjects will be recruited for this study. The primary study outcome variables are: substance use and pain level- pre and post treatment, stress, mood and usual activity levels, sleep patterns and behavioral factors such as anxiety and depression.

   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 veterans with chronic pain and substance use disorder.

   6. Impact/Significance: Pending

• Study Type: Interventional
• Enrollment (Estimated): 125
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cathy M St Pierre, PhD; Phone Number: 781-687-2983; Email: Cathy.StPierre@va.gov

Study Locations

• United States
  • Massachusetts
    • Bedford, Massachusetts, United States, 01730
      • Recruiting
      • Bedford VA Healthcare System
      • Contact: Alexandra Howard, BS; Phone Number: 781-687-3162; Email: Alexandra.Howard@va.gov
      • Contact: Cathy St Pierre, PhD,APRN; Phone Number: 781-687-2983; Email: Cathy.StPierre@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Eligibility criteria include:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Waitlist control; Eight weeks of waitlist control and then 8 weeks of weekly treatment	Other: Battlefield Acupuncture; 5 points of acupuncture treatment in each ear weekly for 8 weeks
Other: Immediate treatment; Eight weeks of weekly treatment and then eight weeks of follow up	Other: Battlefield Acupuncture; 5 points of acupuncture treatment in each ear weekly for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PHQ-4	monthly evaluation of subjects' mood, anxiety level and depression level	monthly for 16 weeks
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.	weekly evaluation of subjects' stress, mood and sleep patterns over 8 weeks. Each question is followed by the pain scale which is from 0-10 (the higher the number, the more pain the patient is experiencing as it relates to the impact of pain on their sleep, mood, stress level and activity.	8 weeks of treatment and 8 weeks of follow up
Substance Use Questionnaire-	Questionnaire evaluating subjects' lifetime and recent substance(s) use.	monthly for 16 weeks

Collaborators and Investigators

• Sponsor: Edith Nourse Rogers Memorial Veterans Hospital
• Collaborators: US Department of Veterans Affairs

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2023
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 26, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: chronic pain; Veterans; Battlefield Acupuncture; Substance Use History
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pain; Neurologic Manifestations; Substance-Related Disorders; Chronic Pain
• Other Study ID Numbers: 1765968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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