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

NCT03525275 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2019-05-20

No results posted yet for this study

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.

Conditions

  • 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

Interventions

DEVICE

Battlefield Acupuncture

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

PROCEDURE

Post-surgical shoulder protocol

Surgery specific post-surgical physical therapy protocol

Sponsors & Collaborators

  • Keller Army Community Hospital

    lead FED

Principal Investigators

  • Keith M Collinsworth, DPT · Keller ACH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-15
Primary Completion
2019-04-15
Completion
2019-04-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03525275 on ClinicalTrials.gov