Opioid UseNCT03525275
Effect of Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone After Shoulder Surgery
A study testing Battlefield Acupuncture and Post-surgical shoulder protocol in people with Opioid Use 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 usual 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 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Pain, Postoperative, SLAP Lesion
- What is being tested?
- Battlefield Acupuncture and Post-surgical shoulder protocol
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2018to 15 Apr 2019
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Department of Defense beneficiaries ages 17-55, prior to or recent (within 24 hrs) shoulder surgery
Who cannot join
- Self-reported pregnancy, History of blood borne pathogens/infectious disease/active infection/metal allergy, 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
West Point, New York, 10996
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 usual 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 24, 72 hours, 7 days, 14 days and at six weeks post-surgery. It is hypothesized that the inclusion of Battlefield Acupuncture will result in a decrease in medication use and post-surgical pain when compared to rehabilitation alone. The population for this study is male and female DoD beneficiaries, ages 17-55 (17 if cadet) that are not participating in other shoulder research studies. The subjects in the experimental group will receive Battlefield Acupuncture in addition to their respective post-surgical shoulder rehabilitation protocol.
Read the detailed description
GROUPS Group assignment will be recorded with individual subject identifier and secured in a separate folder until completion of all data collection through the final follow up.
- Experimental Group: Battlefield Acupuncture with respective shoulder surgery protocol
- Control Group: respective post-surgical Shoulder protocol
All Battlefield Acupuncture will be performed by the PI or AI's who are trained in Battlefield Acupuncture. The Battlefield Acupuncture technique will be standardized. The subject will continue to receive the standard of care in accordance with the post-operative protocol between follow-ups.
Experimental Group: Subjects in the experimental group will receive the usual post-surgical rehabilitation protocol per their surgery in addition to Battlefield Acupuncture. Using sterile technique, Battlefield acupuncture using the 5 points within the Battlefield Acupuncture protocol will be used until the desired 0-1/10 VAS is reported by the subject. The sequencing of the acupuncture begins on the same side of the shoulder surgery. Each ear has 5 points of puncture by the ASP needles. The points, in sequence of puncture are named: cingulate gyrus, thalamus, omega 2, point zero and shen men. The PA/AI using sterile technique (proper hand washing, PPE) will start with the ipsilateral ear. The subjects ear is cleaned with an alcohol swab, and punctured with the ASP needle in the cingulate gyrus. After waiting for pain attenuation/side effect monitoring, the subject will ambulate in the clinic to reassess their perceived pain. If the subjects' pain is above the desired 0-1/10 VAS level, the contralateral ear will be punctured with the ASP needle in the cingulate gyrus under sterile technique. After waiting for pain attenuation/side effect monitoring, the subject will ambulate in the clinic to reassess their perceived pain. If the subjects' pain is above the desired 0-1/10 VAS level, the ipsilateral ear will be punctured with the ASP needle in the thalamus point under sterile technique. After waiting for pain attenuation/side effect monitoring, the subject will ambulate in the clinic to reassess their perceived pain. This sterile acupuncture process will proceed alternating ears until the dominant ear for pain attenuation is determined (using only the 5 Battlefield Acupuncture points) until the desired 0-1/10 VAS level is achieved. The subject will be constantly monitored for side effects to include light headedness, dizziness/loss of balance or nausea. Depending on the subjects' pain response, the ASP needles may be inserted into one ear predominantly, for greater pain attenuation. The ASP needles may remain in the Subjects' ears for 3-5 days. There is no standard time for the ASP needles to remain in the Subjects' ears. The ASP needles will naturally work their way out of the Subject's skin over 3-5 days. There are no documented cases of loss of treatment effect if the Subject removes the ASP needles premature to their natural falling off.
Control Group: Subjects in this group will receive rehabilitation and will perform a home exercise program in accordance with the post-operative shoulder protocol. Subjects will be asked to record compliance on an exercise log. Handouts will be provided to each subject.
Repeat measurement of VAS, PSFS, GROC, and daily opioid/NSAID/acetaminophen use will be taken by the PI/AI or study staff on day one, 72 hours, 7days, 14 days and at 6weeks.
All study subjects will engage in supervised progression of their respective post-surgical protocols. Subjects will be progressed within their respective protocols at a safe pace, and their home exercise program compliance will be monitored throughout the 6 weeks of this study. At any time, a subject may opt out of the study without detriment in their care at KACH/Arvin Clinic.
- Conditions
- Opioid Use, Pain, Postoperative, SLAP Lesion, Bankart Lesion, Subacromial Impingement Syndrome, Rotator Cuff Tear
- Being tested
- Battlefield Acupuncture, Post-surgical shoulder protocol
- Medical subject headings
- Pain, Postoperative, Bankart Lesions, Shoulder Impingement Syndrome, Rotator Cuff Injuries, Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Battlefield AcupunctureDevice
Battlefield Acupuncture uses ASP semi-permanent needles inserted into their ears for pain attenuation in 5 known points. Both groups receive their respective post-surgical rehabilitation protocols
Post-surgical shoulder protocolProcedure or surgery
Surgery specific post-surgical physical therapy protocol
| Study group | Role | What they receive |
|---|---|---|
| BFA with Physical Therapy | Experimental | BFA + post-surgical protocol, intervention = battlefield acupuncture plus post-surgical protocol Receives: Device: Battlefield Acupuncture; Procedure: Post-surgical shoulder protocol |
| Physical Therapy alone | Active comparator | Intervention = Post-surgical protocol Receives: Procedure: Post-surgical shoulder protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain medication use
Patient log of daily pain medication use (opioid, NSAID, acetaminophen), the number of pills per medication will be logged daily over the course of 6 weeks
Measured: daily log, comparison at 24hours, 72hours, 1 week, 2 weeks, 6 weeks
Change in Visual Analog Pain scale report
patient's perceived pain on the Visual Analog Scale, 0 to 100mm scale with higher equaling more pain perceived by the subject, 0 = no pain and 10= worst pain imaginable.
Measured: outcome comparison at 24hours, 72hours, 1 week, 2 weeks, 6 weeks
Secondary outcomes (2)
Change in Global Rating of Change (GROC)
Patient perceived improvement from time of surgery using Global Rating of Change, Scored [-7 to 0 to +7] with 0= "no change", -7 "= "a very great deal worse" and +7="a very great deal better".
Measured: outcome comparison at 24 hours, 72hours, 1 week, 2 weeks, 6 weeks
Change in Patient Specific Functional Scale (PSFS)
Patient perceived functional difficulty in self selected tasks, 0 to 10 scale with 0= unable to perform specific activity and 10 = "able to perform activity the same as prior to surgery".
Measured: outcome comparison at 24 hours, 72hours, 1 week, 2 weeks, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start15 Aug 2018
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid UseStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 x 5 Mixed model ANOVA
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keller Army Community Hospital
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Keith Collinsworth, Keller Army Community Hospital
- Investigators
- Keith M Collinsworth, DPT, Principal investigator, Keller ACH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525275
- Sponsor's protocol ID
- USMA BFA
- Status last verified
- May 2019
- First submitted
- 27 Apr 2018
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. 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
- NCT03525275
- Acronym / sponsor ID
- USMA BFA
- Conditions
- Opioid Use, Pain, Postoperative, SLAP Lesion, Bankart Lesion, Subacromial Impingement Syndrome, Rotator Cuff Tear
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Keller Army Community HospitalUS federal agency
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 15 May 2018 (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 usual 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 24, 72 hours, 7 days, 14 days and at six weeks post-surgery. It is hypothesized that the inclusion of Battlefield Acupuncture will result in a decrease in medication use and post-surgical pain when compared to rehabilitation alone. The population for this study is male and female DoD beneficiaries, ages 17-55 (17 if cadet) that are not participating in other shoulder research studies. The subjects in the experimental group will receive Battlefield Acupuncture in addition to their respective post-surgical shoulder rehabilitation protocol.
Detailed description
GROUPS Group assignment will be recorded with individual subject identifier and secured in a separate folder until completion of all data collection through the final follow up.
- Experimental Group: Battlefield Acupuncture with respective shoulder surgery protocol
- Control Group: respective post-surgical Shoulder protocol
All Battlefield Acupuncture will be performed by the PI or AI's who are trained in Battlefield Acupuncture. The Battlefield Acupuncture technique will be standardized. The subject will continue to receive the standard of care in accordance with the post-operative protocol between follow-ups.
Experimental Group: Subjects in the experimental group will receive the usual post-surgical rehabilitation protocol per their surgery in addition to Battlefield Acupuncture. Using sterile technique, Battlefield acupuncture using the 5 points within the Battlefield Acupuncture protocol will be used until the desired 0-1/10 VAS is reported by the subject. The sequencing of the acupuncture begins on the same side of the shoulder surgery. Each ear has 5 points of puncture by the ASP needles. The points, in sequence of puncture are named: cingulate gyrus, thalamus, omega 2, point zero and shen men. The PA/AI using sterile technique (proper hand washing, PPE) will start with the ipsilateral ear. The subjects ear is cleaned with an alcohol swab, and punctured with the ASP needle in the cingulate gyrus. After waiting for pain attenuation/side effect monitoring, the subject will ambulate in the clinic to reassess their perceived pain. If the subjects' pain is above the desired 0-1/10 VAS level, the contralateral ear will be punctured with the ASP needle in the cingulate gyrus under sterile technique. After waiting for pain attenuation/side effect monitoring, the subject will ambulate in the clinic to reassess their perceived pain. If the subjects' pain is above the desired 0-1/10 VAS level, the ipsilateral ear will be punctured with the ASP needle in the thalamus point under sterile technique. After waiting for pain attenuation/side effect monitoring, the subject will ambulate in the clinic to reassess their perceived pain. This sterile acupuncture process will proceed alternating ears until the dominant ear for pain attenuation is determined (using only the 5 Battlefield Acupuncture points) until the desired 0-1/10 VAS level is achieved. The subject will be constantly monitored for side effects to include light headedness, dizziness/loss of balance or nausea. Depending on the subjects' pain response, the ASP needles may be inserted into one ear predominantly, for greater pain attenuation. The ASP needles may remain in the Subjects' ears for 3-5 days. There is no standard time for the ASP needles to remain in the Subjects' ears. The ASP needles will naturally work their way out of the Subject's skin over 3-5 days. There are no documented cases of loss of treatment effect if the Subject removes the ASP needles premature to their natural falling off.
Control Group: Subjects in this group will receive rehabilitation and will perform a home exercise program in accordance with the post-operative shoulder protocol. Subjects will be asked to record compliance on an exercise log. Handouts will be provided to each subject.
Repeat measurement of VAS, PSFS, GROC, and daily opioid/NSAID/acetaminophen use will be taken by the PI/AI or study staff on day one, 72 hours, 7days, 14 days and at 6weeks.
All study subjects will engage in supervised progression of their respective post-surgical protocols. Subjects will be progressed within their respective protocols at a safe pace, and their home exercise program compliance will be monitored throughout the 6 weeks of this study. At any time, a subject may opt out of the study without detriment in their care at KACH/Arvin Clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 x 5 Mixed model ANOVA
| Arm | Type | Receives |
|---|---|---|
| BFA with Physical Therapy | Experimental | Device: Battlefield Acupuncture, Procedure: Post-surgical shoulder protocolBFA + post-surgical protocol, intervention = battlefield acupuncture plus post-surgical protocol |
| Physical Therapy alone | Active comparator | Procedure: Post-surgical shoulder protocolIntervention = Post-surgical protocol |
Who may qualify
- Ages
- 17 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Department of Defense beneficiaries ages 17-55, prior to or recent (within 24 hrs) shoulder surgery
Key exclusion criteria (1 listed)
- Self-reported pregnancy, History of blood borne pathogens/infectious disease/active infection/metal allergy, 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 uses ASP semi-permanent needles inserted into their ears for pain attenuation in 5 known points. Both groups receive their respective post-surgical rehabilitation protocols | Device | BFA with Physical Therapy |
| Post-surgical shoulder protocolSurgery specific post-surgical physical therapy protocol | Procedure or surgery | BFA with Physical Therapy, Physical Therapy alone |
Primary outcome
Change in Pain medication use
Time frame: daily log, comparison at 24hours, 72hours, 1 week, 2 weeks, 6 weeks
Patient log of daily pain medication use (opioid, NSAID, acetaminophen), the number of pills per medication will be logged daily over the course of 6 weeks
Change in Visual Analog Pain scale report
Time frame: outcome comparison at 24hours, 72hours, 1 week, 2 weeks, 6 weeks
patient's perceived pain on the Visual Analog Scale, 0 to 100mm scale with higher equaling more pain perceived by the subject, 0 = no pain and 10= worst pain imaginable.
2 secondary outcomes
Change in Global Rating of Change (GROC)
Time frame: outcome comparison at 24 hours, 72hours, 1 week, 2 weeks, 6 weeks
Change in Patient Specific Functional Scale (PSFS)
Time frame: outcome comparison at 24 hours, 72hours, 1 week, 2 weeks, 6 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 20 May 2019.
- 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.
Keith M Collinsworth, DPT principal investigator
Keller ACH
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 Post-surgical shoulder protocol in people with Opioid Use 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 1 inclusion and 1 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 20 May 2019. 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?
Change in Pain medication use (time frame: daily log, comparison at 24hours, 72hours, 1 week, 2 weeks, 6 weeks). 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?
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 20 May 2019.