Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair

NCT04848103 | Completed

• 1 other identifier: 2-1040781-A-N-012021035HR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Although radial extracorporeal shock wave therapy (rESWT) has proven to be an effective treatment, the effectiveness of the treatment has so far been controversial. There are no studies using rESWT in rehabilitation after arthroscopic rotator cuff repair (ARCR). Therefore, in this study, there is evidence that rESWT promotes pain control and healing recovery, and through previous studies, we would like to investigate whether treatment with rESWT during the intensive rehabilitation period of patients after ARCR is more effective in controlling pain.

Conditions

Rotator Cuff Injuries; Pain, Postoperative; Tissue Adhesion

Outcome Measures

Primary Outcomes (1)

• . Pain intensity

  A numeric pain rating scale (NPRS) consisting of 11 points in total from 0 points (no pain) to 10 points (the most severe pain imaginable) is used. The lower the score, the less the pain.

  Change from baseline pain intensity at 2 weeks

Study Arms (1)

Radial extracorporeal shockwave therapy

EXPERIMENTAL

Behavioral: Radial extracorporeal shockwave therapy

Interventions

Radial extracorporeal shockwave therapy BEHAVIORAL

Radial extracorporeal shockwave therapy group include Therapeutic modality(Transcutaneous electrical nerve stimulation \[TENS\], Microwave thermotherapy, and Superficial heat therapy), Range of motion exercise(Continuous passive motion and Active range of motion exercise).

Radial extracorporeal shockwave therapy

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 18 years old
• In case of 6 weeks after receiving arthroscopic rotator cuff repair
• When the participants wishes to enroll in the study

You may not qualify if:

• years old or older
• If the tear area is large and augmentation is performed
• If there is a previous surgical history at the surgical site
• Osteoarthritis in the shoulder joint

Sponsors & Collaborators

• Sahmyook University: lead

Study Sites (1)

The Better Hospital

Gwangju, 61085, South Korea

Location

Related Publications (1)

• Kim HJ, Choi W, Jung J, Park S, Joo Y, Lee S, Lee S. Efficacy of radial extracorporeal shockwave therapy in rehabilitation following arthroscopic rotator cuff repair: A STROBE compliant study. Medicine (Baltimore). 2022 Sep 2;101(35):e30053. doi: 10.1097/MD.0000000000030053.

  PMID: 36107497 DERIVED

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain, Postoperative; Tissue Adhesions

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Cicatrix; Fibrosis

Study Officials

• Hyun-Joong Kim, MSc

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: May 10, 2021
• Primary Completion: June 30, 2021
• Study Completion: July 8, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)