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Effect of Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone After Shoulder Surgery

Primary Purpose

Opioid Use, Pain, Postoperative, SLAP Lesion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Battlefield Acupuncture
Post-surgical shoulder protocol
Sponsored by
Keller Army Community Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use

Eligibility Criteria

17 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Keller Army Community Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BFA with Physical Therapy

Physical Therapy alone

Arm Description

BFA + post-surgical protocol, intervention = battlefield acupuncture plus post-surgical protocol

Intervention = Post-surgical protocol

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

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".
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".

Full Information

First Posted
April 27, 2018
Last Updated
May 16, 2019
Sponsor
Keller Army Community Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03525275
Brief Title
Effect of Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone After Shoulder Surgery
Official Title
The Effect of Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone Following Shoulder Surgery: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keller Army Community Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Pain, Postoperative, SLAP Lesion, Bankart Lesion, Subacromial Impingement Syndrome, Rotator Cuff Tear, Glenohumeral Dislocation, Glenohumeral Subluxation, Hill Sach Lesion, Bony Bankart Lesion, Acromioclavicular Separation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 x 5 Mixed model ANOVA
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BFA with Physical Therapy
Arm Type
Experimental
Arm Description
BFA + post-surgical protocol, intervention = battlefield acupuncture plus post-surgical protocol
Arm Title
Physical Therapy alone
Arm Type
Active Comparator
Arm Description
Intervention = Post-surgical protocol
Intervention Type
Device
Intervention Name(s)
Battlefield Acupuncture
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Post-surgical shoulder protocol
Intervention Description
Surgery specific post-surgical physical therapy protocol
Primary Outcome Measure Information:
Title
Change in Pain medication use
Description
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
Time Frame
daily log, comparison at 24hours, 72hours, 1 week, 2 weeks, 6 weeks
Title
Change in Visual Analog Pain scale report
Description
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.
Time Frame
outcome comparison at 24hours, 72hours, 1 week, 2 weeks, 6 weeks
Secondary Outcome Measure Information:
Title
Change in Global Rating of Change (GROC)
Description
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".
Time Frame
outcome comparison at 24 hours, 72hours, 1 week, 2 weeks, 6 weeks
Title
Change in Patient Specific Functional Scale (PSFS)
Description
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".
Time Frame
outcome comparison at 24 hours, 72hours, 1 week, 2 weeks, 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith M Collinsworth, DPT
Organizational Affiliation
Keller ACH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keller Army Community Hospital
City
West Point
State/Province
New York
ZIP/Postal Code
10996
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Battlefield Acupuncture and Physical Therapy Versus Physical Therapy Alone After Shoulder Surgery

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