Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair

• Sponsor: Sahmyook University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04848103
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 1.9
• Patients Per Site Per Month: 15.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rotator Cuff Injuries; Pain, Postoperative; Tissue Adhesion	Behavioral: Radial extracorporeal shockwave therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair
• Actual Study Start Date: May 10, 2021
• Actual Primary Completion Date: Jun 30, 2021
• Actual Study Completion Date: Jul 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Radial extracorporeal shockwave therapy	Behavioral: Radial extracorporeal shockwave therapy; 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).

Outcome Measures

Primary Outcome Measures

1. . Pain intensity [Change from baseline pain intensity at 2 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 65 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Better Hospital	Gwangju		Korea, Republic of	61085

Sponsors and Collaborators

• Sahmyook University

Investigators

• Principal Investigator: Hyun-Joong Kim, MSc, Principal Investigator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hyun-Joong Kim, Principal investigator, Sahmyook University
• ClinicalTrials.gov Identifier: NCT04848103
• Other Study ID Numbers: 2-1040781-A-N-012021035HR
• First Posted: Apr 19, 2021
• Last Update Posted: Jul 13, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Tissue Adhesions; Rotator Cuff Injuries

Study Results

No Results Posted as of Jul 13, 2021