AcupunctureNCT05417724
Utilizing Battlefield Acupuncture(BFA) to Treat Chronic Pain for Homeless and at Risk Veterans.
A study testing Battlefield Acupuncture in people with Acupuncture and Homelessness, run by Edith Nourse Rogers Memorial Veterans Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Acupuncture, Homelessness, Pain
- What is being tested?
- Battlefield Acupuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Mar 2022to 5 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Bedford VA Healthcare System
Bedford, Massachusetts, 01730
About this study
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.
Read the detailed description
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
- Conditions
- Acupuncture, Homelessness, Pain, Veterans
- Being tested
- Battlefield Acupuncture
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Battlefield AcupunctureOther
Battlefield Acupuncture
| Study group | Role | What they receive |
|---|---|---|
| Battlefield Acupuncture | Other | All subjects will receive BFA treatment weekly for 12 weeks. Receives: Other: Battlefield Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (3)
Change in pain may impact behavioral health issues.
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.
Measured: 4 months
Change in pain may impact housing stability
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
Measured: 4 months
Change in pain may impact substance use.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start28 Mar 2022
- Primary completion5 Sep 2023
- Study completion5 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcupunctureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Recruitment of veterans with chronic pain who are interested in being treated with Battlefield Acupuncture (BFA).
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edith Nourse Rogers Memorial Veterans Hospital
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Cathy St. Pierre, Edith Nourse Rogers Memorial Veterans Hospital
- Investigators
- John Wells, PhD, Study chair, Edith Nourse Rogers Memorial Veterans Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417724
- Sponsor's protocol ID
- 1645513
- Status last verified
- Dec 2023
- First submitted
- 19 May 2022
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to do this.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Battlefield Acupuncture(BFA) to Treat Chronic Pain for Homeless and at Risk Veterans.
- ClinicalTrials.gov ID
- NCT05417724
- Acronym / sponsor ID
- 1645513
- Conditions
- Acupuncture, Homelessness, Pain, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Edith Nourse Rogers Memorial Veterans HospitalUS federal agency
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- 5 Sep 2023 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Recruitment of veterans with chronic pain who are interested in being treated with Battlefield Acupuncture (BFA).
| Arm | Type | Receives |
|---|---|---|
| Battlefield Acupuncture | Other | Other: Battlefield AcupunctureAll subjects will receive BFA treatment weekly for 12 weeks. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Battlefield AcupunctureBattlefield Acupuncture | Other | Battlefield Acupuncture |
Primary outcome
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.
3 secondary outcomes
Change in pain may impact behavioral health issues.
Time frame: 4 months
Change in pain may impact housing stability
Time frame: 4 months
Change in pain may impact substance use.
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Individual participant dataSharing planned: No. No plan to do this.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Wells, PhD study chair
Edith Nourse Rogers Memorial Veterans Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Battlefield Acupuncture in people with Acupuncture and Homelessness, run by Edith Nourse Rogers Memorial Veterans Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in pain (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.