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| Name | Class |
|---|---|
| Uniformed Services University of the Health Sciences | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | Participants in the experimental group will receive standard post-surgical rehabilitation protocol per their surgery in addition to Battlefield Acupuncture. |
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| Control Group | Active Comparator | Participants in the control group will receive standard post-surgical rehabilitation protocol per their surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Battlefield Acupuncture | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 72 hours, 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keller Army Community Hospital - Arvin Physical Therapy | West Point | New York | 10966 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39797512 | Result | 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. | |
| 33272311 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 24, 2023 | Jun 25, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000070599 | Shoulder Injuries |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Standard post-surgical rehabilitation | Procedure | 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. |
|
| 72 hours, 1 week, 4 weeks |
| Medication Use | Daily opioid, NSAID, and Acetaminophen use | 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. | 4 weeks |
| Crowell 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. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |