Pain, Postoperative Clinical Trial
Official title:
The Effect of Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone Following Shoulder Surgery: A Randomized Clinical Trial
NCT number | NCT03525275 |
Other study ID # | USMA BFA |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 15, 2018 |
Est. completion date | April 15, 2019 |
Verified date | May 2019 |
Source | Keller Army Community Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | April 15, 2019 |
Est. primary completion date | April 15, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 17 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Department of Defense beneficiaries ages 17-55, prior to or recent (within 24 hrs) shoulder surgery Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Keller Army Community Hospital | West Point | New York |
Lead Sponsor | Collaborator |
---|---|
Keller Army Community Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | daily log, comparison at 24hours, 72hours, 1 week, 2 weeks, 6 weeks | |
Primary | 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. | outcome comparison at 24hours, 72hours, 1 week, 2 weeks, 6 weeks | |
Secondary | 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". | outcome comparison at 24 hours, 72hours, 1 week, 2 weeks, 6 weeks | |
Secondary | 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". | outcome comparison at 24 hours, 72hours, 1 week, 2 weeks, 6 weeks |
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