Battlefield Acupuncture Following Shoulder Surgery (BFA)
Primary Purpose
Shoulder Injuries, Pain, Postoperative, Acupuncture, Ear
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Battlefield Acupuncture
Standard post-surgical rehabilitation
Sponsored by
About this trial
This is an interventional supportive care trial for Shoulder Injuries
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Keller Army Community Hospital - Arvin Physical TherapyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental Group
Control Group
Arm Description
Participants in the experimental group will receive standard post-surgical rehabilitation protocol per their surgery in addition to Battlefield Acupuncture.
Participants in the control group will receive standard post-surgical rehabilitation protocol per their surgery.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Medication Use
Daily opioid, NSAID, and Acetaminophen use
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.
Full Information
NCT ID
NCT04094246
First Posted
September 16, 2019
Last Updated
October 18, 2021
Sponsor
Keller Army Community Hospital
Collaborators
Uniformed Services University of the Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04094246
Brief Title
Battlefield Acupuncture Following Shoulder Surgery
Acronym
BFA
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
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 25, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keller Army Community Hospital
Collaborators
Uniformed Services University of the Health Sciences
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Injuries, Pain, Postoperative, Acupuncture, Ear, Pain Management
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Participants in the experimental group will receive standard post-surgical rehabilitation protocol per their surgery in addition to Battlefield Acupuncture.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants in the control group will receive standard post-surgical rehabilitation protocol per their surgery.
Intervention Type
Procedure
Intervention Name(s)
Battlefield Acupuncture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Standard post-surgical rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Worst overall pain assessed by Visual Analogue Scale (VAS)
Description
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.
Time Frame
72 hours, 1 week
Title
Average 24-hour pain assessed by Visual Analogue Scale (VAS)
Description
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.
Time Frame
72 hours, 1 week
Secondary Outcome Measure Information:
Title
Patient self-reported mood assessed by the Profile of Mood States (POMS) Questionnaire
Description
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.
Time Frame
72 hours, 1 week, 4 weeks
Title
Medication Use
Description
Daily opioid, NSAID, and Acetaminophen use
Time Frame
1 week, 4 weeks
Title
Worst overall pain and average pain in the past 24 hours assessed by Visual Analogue Scale (VAS)
Description
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.
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Crowell, PT, DSc
Phone
8459383067
Email
michael.s.crowell.mil@mail.mil
Facility Information:
Facility Name
Keller Army Community Hospital - Arvin Physical Therapy
City
West Point
State/Province
New York
ZIP/Postal Code
10966
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Crowell, DPT
Phone
845-938-3067
Email
michael.s.crowell.mil@mail.mil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33272311
Citation
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.
Results Reference
derived
Learn more about this trial
Battlefield Acupuncture Following Shoulder Surgery
We'll reach out to this number within 24 hrs