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Clinical Trials/NCT06587009
NCT06587009RecruitingNot Applicable

Director of Rehabilitation Medicine

Peking University Third Hospital1 site in 1 country22 target enrollmentStarted: May 5, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
22
Locations
1
Primary Endpoint
pain VAS score

Study Overview

Brief Summary

This study is a prospective cohort study and is a single-center clinical trial. Sample: This study will enroll about 22 patients from the Department of Sports Medicine and rehabilitation outpatient department of Beijing Third Hospital who are diagnosed with rotator cuff tear and choose conservative treatment.

Detailed Description

A single-center randomized controlled clinical trial was conducted to compare the effect of ESWT combined with conventional rehabilitation training on patients with rotator cuff tear. To explore the effect of ESWT on the clinical efficacy of patients with rotator cuff tear, and to explore the application of shockwave technology in the conservative treatment of rotator cuff tear. It provides a new treatment idea for patients with rotator cuff tear who choose conservative treatment, promotes tendon healing for patients with partial rotator cuff tear, improves shoulder joint function, and provides a new treatment plan for patients to accelerate their return to life and exercise, and provides a theoretical basis for the clinical application of ESWT.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
17 Years to 75 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Identify patients with rotator cuff tears and choose conservative treatment
  • Able to complete cardiopulmonary exercise tests
  • Able to cooperate with rehabilitation training and complete questionnaire survey

Exclusion Criteria

  • Previous shoulder surgery history
  • Irreparable rotator cuff damage
  • Retear after ARCR

Outcomes

Primary Outcomes

pain VAS score

Time Frame: 6 weeks, 3 months, and 6 months after surgery

pain levels in patients, ranging from 0 to 10, with a higher score indicating more intense pain.

ASES score

Time Frame: 6 weeks, 3 months, and 6 months after surgery

The American Shoulder and Elbow Surgeons (ASES) score is the most commonly used score to describe the function of patients' shoulder joints, ranging from 0 to 100. The higher the score, the better the function of patients' shoulder joints.

MRI evaluation

Time Frame: 3 months and 6 month after surgery

Through MRI qualitative and quantitative analysis, evaluate the tendon healing status after rotator cuff repair surgery.

UCLA score

Time Frame: 6 weeks, 3 months and 6 months after surgery

The UCLA Shoulder Score combines input from both the physician and the patient and totals range from 0 to 35, 0s indicating worse shoulder function and 35s indicating better shoulder function outcomes.

Secondary Outcomes

  • Active shoulder ranges of motion(6 weeks, 3 months, and 6 months after surgery)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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