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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.
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Bedford VA Healthcare System
Bedford, Massachusetts, United States
Start Date
December 30, 2023
Primary Completion Date
December 30, 2025
Completion Date
December 30, 2026
Last Updated
August 28, 2024
125
ESTIMATED participants
Battlefield Acupuncture
OTHER
Lead Sponsor
Edith Nourse Rogers Memorial Veterans Hospital
Collaborators
NCT04197921
NCT04379115
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06587607