Application of Shock Wave Technique in Conservative Treatment of Rotator Cuff Tear

NCT06587009 | Recruiting DMC

• 1 other identifier: M2024208
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear

Keywords

Shock wave technique; Conservative treatment

Outcome Measures

Primary Outcomes (4)

• pain VAS score

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

  6 weeks, 3 months, and 6 months after surgery

• ASES score

  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.

  6 weeks, 3 months, and 6 months after surgery

• MRI evaluation

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

  3 months and 6 month after surgery

• UCLA score

  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.

  6 weeks, 3 months and 6 months after surgery

Secondary Outcomes (1)

• Active shoulder ranges of motion

  6 weeks, 3 months, and 6 months after surgery

Study Arms (2)

ESWT group

EXPERIMENTAL

Patients who receive shock wave technique

Procedure: Shock wave therapy

Control group

EXPERIMENTAL

Patients who receive conventional conservative treatment

Procedure: Conventional conservative treatment

Interventions

Shock wave therapy PROCEDURE

Received shock wave therapy 7 times a week and functional exercise therapy intervention

ESWT group

Conventional conservative treatment PROCEDURE

Conventional conservative treatment and functional exercise were given

Control group

Eligibility Criteria

• Age: 17 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

PekingUTH

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Extracorporeal Shockwave Therapy

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Guoqing Cui

  Peking University Third Hospital

  STUDY CHAIR

Central Study Contacts

Amila Kuati

CONTACT

17888810849; amilakuati@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: May 5, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)