Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair

Pain, Postoperative Clinical Trial

Official title:

Effect of Extracorporeal Shock Wave Therapy After Arthroscopic Rotator Cuff Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04848103
• Other study ID #: 2-1040781-A-N-012021035HR
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: July 8, 2021

Study information

• Verified date: July 2021
• Source: Sahmyook University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 8, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Rotator Cuff Injuries
• Tissue Adhesion
• Tissue Adhesions

Intervention

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).

Locations

Country	Name	City	State
Korea, Republic of	The Better Hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Sahmyook University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	. 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