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NCT Number: NCT06587009

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

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.

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Key information

Conditions

Rotator Cuff Tear Rotator Cuff Injuries Rupture Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

17 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PekingUTH

Beijing, Beijing Municipality, China

Location status: Recruiting

Location contact

Guoqing Cui, professor

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shock wave therapy

Procedure

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

Conventional conservative treatment

Procedure

Conventional conservative treatment and functional exercise were given

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. Active shoulder ranges of motion

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

    internal rotation at the side, and external and internal rotation at 90° of abduction

Study contacts

Contact information is provided by the study sponsor or research team.

Amila Kuati

CONTACT

[email protected]

17888810849

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Official study title

Director of Rehabilitation Medicine

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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