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

NCT03525275 | Completed

• 1 other identifier: USMA BFA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Change in Global Rating of Change (GROC)

  outcome comparison at 24 hours, 72hours, 1 week, 2 weeks, 6 weeks

• Change in Patient Specific Functional Scale (PSFS)

  outcome comparison at 24 hours, 72hours, 1 week, 2 weeks, 6 weeks

Study Arms (2)

BFA with Physical Therapy

EXPERIMENTAL

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

Device: Battlefield Acupuncture; Procedure: Post-surgical shoulder protocol

Physical Therapy alone

ACTIVE COMPARATOR

Intervention = Post-surgical protocol

Procedure: Post-surgical shoulder protocol

Interventions

Battlefield Acupuncture DEVICE

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

BFA with Physical Therapy

Post-surgical shoulder protocol PROCEDURE

Surgery specific post-surgical physical therapy protocol

BFA with Physical Therapy; Physical Therapy alone

Eligibility Criteria

• Age: 17 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Department of Defense beneficiaries ages 17-55, prior to or recent (within 24 hrs) shoulder surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Keller Army Community Hospital: lead

Study Sites (1)

Keller Army Community Hospital

West Point, New York, 10996, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Bankart Lesions; Shoulder Impingement Syndrome; Rotator Cuff Injuries; Shoulder Dislocation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Shoulder Fractures; Fractures, Bone; Wounds and Injuries; Shoulder Injuries; Joint Diseases; Musculoskeletal Diseases; Rupture; Tendon Injuries; Joint Dislocations

Study Officials

• Keith M Collinsworth, DPT

  Keller ACH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 2 x 5 Mixed model ANOVA

Study Record Dates

• First Submitted: April 27, 2018
• First Posted: May 15, 2018
• Study Start: August 15, 2018
• Primary Completion: April 15, 2019
• Study Completion: April 15, 2019
• Last Updated: May 20, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)