Shoulder InjuriesBFANCT04094246
Battlefield Acupuncture Following Shoulder Surgery
A study testing Battlefield Acupuncture and Standard post-surgical rehabilitation in people with Shoulder Injuries and Pain, Postoperative, run by Keller Army Community Hospital at 1 site in United States.
Trial summary
The purpose of this randomized clinical trial is to determine the effectiveness of Battlefield Acupuncture (BFA) in addition to standard post-surgical shoulder physical therapy compared to a standard shoulder rehabilitation program in reducing medication use and pain in patients who have undergone shoulder surgery. Read more about this study
- Who is it for?
- Ages 17 to 55 years
- Conditions the study is for
- Shoulder Injuries, Pain, Postoperative, Acupuncture, Ear
- What is being tested?
- Battlefield Acupuncture and Standard post-surgical rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2019to 29 May 2024
- 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 17 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 17-55 Department of Defense beneficiaries (17 only if an emancipated cadet at the U.S. Military Academy)
- Prior to or within 48 hours post shoulder stabilization surgery
- Prior to or within 48 hours post rotator cuff repair surgery
Who cannot join
- Self-reported pregnancy
- History of blood borne pathogens, infectious disease, or active infection
- History of metal allergy
- History of bleeding disorders or currently taking anti-coagulant medications
- Participants who are not fluent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Keller Army Community Hospital - Arvin Physical Therapy
West Point, New York, 10966
About this study
Official title: The Effect of Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone Following Shoulder Surgery: A Randomized Clinical Trial
The purpose of this randomized clinical trial is to determine the effectiveness of Battlefield Acupuncture (BFA) in addition to standard post-surgical shoulder physical therapy compared to a standard shoulder rehabilitation program in reducing medication use and pain in patients who have undergone shoulder surgery. Measurements of medication (opioid, NSAID, acetaminophen, etc.) use (daily number of pills consumed), pain rating, patient specific functional scale and global rating of change will be taken at 48-hours (baseline), 72-hours, 1-week, and 4-weeks post-surgery. It is hypothesized that the inclusion of Battlefield Acupuncture will result in a decrease in post-surgical pain levels, reduced opioid medication use, and improved patient mood when compared to rehabilitation alone.
- Being tested
- Battlefield Acupuncture, Standard post-surgical rehabilitation
- Medical subject headings
- Shoulder Injuries, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Battlefield AcupunctureProcedure or surgery
Battlefield Acupuncture (BFA), an auricular acupuncture protocol developed in 2001 by Dr. Niemtzow (Ret. Colonel, USAF), is widely used among civilian and military medical providers to treat pain. Participants in the Experimental Group will receive BFA in addition to standard post-surgical rehabilitation up to four times following their shoulder surgery: 24-hours, 48-hours, 72-hours, and 1-week post-surgery.
Standard post-surgical rehabilitationProcedure or surgery
Participants will receive rehabilitation and will perform a home exercise program in accordance with the standard post-operative shoulder protocol. Participants will be asked to record compliance on an exercise log.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants in the experimental group will receive standard post-surgical rehabilitation protocol per their surgery in addition to Battlefield Acupuncture. Receives: Procedure: Battlefield Acupuncture |
| Control Group | Active comparator | Participants in the control group will receive standard post-surgical rehabilitation protocol per their surgery. Receives: Procedure: Standard post-surgical rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst overall pain assessed by Visual Analogue Scale (VAS)
Worst pain intensity in the past 24 hours recorded using a 0-10 cm visual analog scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain.
Measured: 72 hours, 1 week
Average 24-hour pain assessed by Visual Analogue Scale (VAS)
Average pain intensity in the past 24 hours recorded using a 0-10 cm visual analog scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain.
Measured: 72 hours, 1 week
Secondary outcomes (3)
Patient self-reported mood assessed by the Profile of Mood States (POMS) Questionnaire
The POMS consists of 65 measures of mood organized into 6 mood scales: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. Individual scales are combined to achieve the mood disturbance score (MDS), an aggregate indicator of overall mood. A greater MDS value indicates greater mood disturbance.
Measured: 72 hours, 1 week, 4 weeks
Medication Use
Daily opioid, NSAID, and Acetaminophen use
Measured: 1 week, 4 weeks
Worst overall pain and average pain in the past 24 hours assessed by Visual Analogue Scale (VAS)
Worst pain intensity and average pain intensity in the past 24 hours recorded using a 0-10 cm visual analog scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start25 Sep 2019
- Primary completion29 May 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder InjuriesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keller Army Community Hospital
- Sponsor type
- US federal agency
- Collaborators
- Uniformed Services University of the Health Sciences
- Responsible party
- Principal investigator, Michael Crowell, Keller Army Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094246
- Sponsor's protocol ID
- 19KACH003
- Acronym
- BFA
- Status last verified
- Feb 2025
- First submitted
- 16 Sep 2019
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Crowell MS, Florkiewicz EM, Morris JB, Mason JS, Pitt W, Benedict T, Cameron KL, Goss DL. Battlefield Acupuncture Does Not Provide Additional Improvement in Pain When Combined With Standard Physical Therapy After Shoulder Surgery: A Randomized Clinical Trial. Mil Med. 2025 Jun 30;190(7-8):e1509-e1517. doi: 10.1093/milmed/usae577.
PubMed 39797512Crowell MS, Brindle RA, Mason JS, Pitt W, Miller EM, Posner MA, Cameron KL, Goss DL. The effectiveness of battlefield acupuncture in addition to standard physical therapy treatment after shoulder surgery: a protocol for a randomized clinical trial. Trials. 2020 Dec 3;21(1):995. doi: 10.1186/s13063-020-04909-8.
PubMed 33272311
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone Following Shoulder Surgery: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04094246
- Acronym / sponsor ID
- BFA / 19KACH003
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Keller Army Community HospitalUS federal agency
- Collaborators
- Uniformed Services University of the Health Sciences
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 29 May 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 18 Sep 2019 (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.
The purpose of this randomized clinical trial is to determine the effectiveness of Battlefield Acupuncture (BFA) in addition to standard post-surgical shoulder physical therapy compared to a standard shoulder rehabilitation program in reducing medication use and pain in patients who have undergone shoulder surgery. Measurements of medication (opioid, NSAID, acetaminophen, etc.) use (daily number of pills consumed), pain rating, patient specific functional scale and global rating of change will be taken at 48-hours (baseline), 72-hours, 1-week, and 4-weeks post-surgery. It is hypothesized that the inclusion of Battlefield Acupuncture will result in a decrease in post-surgical pain levels, reduced opioid medication use, and improved patient mood when compared to rehabilitation alone.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Battlefield AcupunctureParticipants in the experimental group will receive standard post-surgical rehabilitation protocol per their surgery in addition to Battlefield Acupuncture. |
| Control Group | Active comparator | Procedure: Standard post-surgical rehabilitationParticipants in the control group will receive standard post-surgical rehabilitation protocol per their surgery. |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 17-55 Department of Defense beneficiaries (17 only if an emancipated cadet at the U.S. Military Academy)
- Prior to or within 48 hours post shoulder stabilization surgery
- Prior to or within 48 hours post rotator cuff repair surgery
Key exclusion criteria (5 listed)
- Self-reported pregnancy
- History of blood borne pathogens, infectious disease, or active infection
- History of metal allergy
- History of bleeding disorders or currently taking anti-coagulant medications
- Participants who are not fluent in English
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 (BFA), an auricular acupuncture protocol developed in 2001 by Dr. Niemtzow (Ret. Colonel, USAF), is widely used among civilian and military medical providers to treat pain. Participants in the Experimental Group will receive BFA in addition to standard post-surgical rehabilitation up to four times following their shoulder surgery: 24-hours, 48-hours, 72-hours, and 1-week post-surgery. | Procedure or surgery | Experimental Group |
| Standard post-surgical rehabilitationParticipants will receive rehabilitation and will perform a home exercise program in accordance with the standard post-operative shoulder protocol. Participants will be asked to record compliance on an exercise log. | Procedure or surgery | Control Group |
Primary outcome
Worst overall pain assessed by Visual Analogue Scale (VAS)
Time frame: 72 hours, 1 week
Worst pain intensity in the past 24 hours recorded using a 0-10 cm visual analog scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain.
Average 24-hour pain assessed by Visual Analogue Scale (VAS)
Time frame: 72 hours, 1 week
Average pain intensity in the past 24 hours recorded using a 0-10 cm visual analog scale where 0 equals no pain and 10 indicates the most severe pain the patient could imagine. Higher numbers equal greater levels of reported pain.
3 secondary outcomes
Patient self-reported mood assessed by the Profile of Mood States (POMS) Questionnaire
Time frame: 72 hours, 1 week, 4 weeks
Medication Use
Time frame: 1 week, 4 weeks
Worst overall pain and average pain in the past 24 hours assessed by Visual Analogue Scale (VAS)
Time frame: 4 weeks
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 25 Feb 2025.
- Results publication: PubMed 39797512Crowell MS, Florkiewicz EM, Morris JB, Mason JS, Pitt W, Benedict T, Cameron KL, Goss DL. Battlefield Acupuncture Does Not Provide Additional Improvement in Pain When Combined With Standard Physical Therapy After Shoulder Surgery: A Randomized Clinical Trial. Mil Med. 2025 Jun 30;190(7-8):e1509-e1517. doi: 10.1093/milmed/usae577.
- Derived from this study: PubMed 33272311Crowell MS, Brindle RA, Mason JS, Pitt W, Miller EM, Posner MA, Cameron KL, Goss DL. The effectiveness of battlefield acupuncture in addition to standard physical therapy treatment after shoulder surgery: a protocol for a randomized clinical trial. Trials. 2020 Dec 3;21(1):995. doi: 10.1186/s13063-020-04909-8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Standard post-surgical rehabilitation in people with Shoulder Injuries and Pain, Postoperative, run by Keller Army Community 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 3 inclusion and 5 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 25 Feb 2025. 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?
Worst overall pain assessed by Visual Analogue Scale (VAS) (time frame: 72 hours, 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04094246, which also lists 2 linked publications.
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 25 Feb 2025.