Ultrasound Imaging of Fibrotic Tissue

NCT05818904 | Unknown DMC

• 1 other identifier: M2022793
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This project intends to collect the ultrasonic spectrum information of shoulder and knee joint fibrotic tissue, and use machine learning to study the mechanism of fibrosis tissue ultrasound imaging, and then build a model and finally establish the relationship between joint stiffness and fibrosis formation. In this study, the broadband ultrasound imaging method for joint fibrosis has the potential to create a method for ultrasonic localization, staining and evaluation of joint fibrosis, laying the foundation for the research of new conservative treatment methods and surgical positioning for fibrosis, and for reducing the occurrence of joint fibrosis rate, improve joint function of patients, and return to family and society earlier and better

Conditions

Arthrofibrosis of Knee; Arthrofibrosis of Shoulder

Outcome Measures

Primary Outcomes (2)

• KOOS score

  The KOOS (Knee injury and Osteoarthritis Outcome Score) survey is a health questionnaire used to assess the impact of knee injury or osteoarthritis on patients. It has 42 questions covering 5 domains and is rated on a 5-point Likert scale. The scale ranges from 0 to 100, with higher scores indicating better outcomes. The KOOS survey is a reliable and valid tool used in research and clinical practice to assess treatment effectiveness and track symptom changes over time.

  3-month

• CM score

  The Constant-Murley survey is a health questionnaire used to evaluate shoulder function and pain. It consists of four domains: pain, activities of daily living, range of motion, and strength. The scale ranges from 0 to 100, with higher scores indicating better outcomes. The Constant-Murley survey is a reliable and valid tool used in research and clinical practice to assess treatment effectiveness and track symptom changes over time.

  3-month

Secondary Outcomes (3)

• SF-36

  3-month

• WOMAC

  3-month

• HSS-KS

  3-month

Study Arms (3)

Healthy

Healthy group is recruited. They would not receive any intervention. The ultrasound imaging data will be collected to serve as the comparison for no fibrosis joint.

Arthrosis of knee

People with arthrosis of the knee joint will be treated using the traditional intervention, which includes physical therapy. The ultrasound imaging will be collected before the intervention and at 3-month. The imaging data will be used to build a imaging model using the machine learning method.

Other: Physical Therapy

arthrosis of shoulder

People with arthrosis of the shoulder joint will be treated using the traditional intervention, which includes physical therapy. The ultrasound imaging will be collected before the intervention and at 3-month. The imaging data will be used to build a imaging model using the machine learning method.

Other: Physical Therapy

Interventions

Physical Therapy OTHER

All arthrosis participants will be treated as the traditional methods using physical therapy.

Arthrosis of knee; arthrosis of shoulder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Joint stiffness patients

You may qualify if:

• Unilateral shoulder or knee joint stiffness and normal on the opposite side
• The course of the disease is longer than 3 months
• Good cognitive function, able to understand the content of this experiment, willing to cooperate with follow-up
• Over 18 years old, voluntarily participate in this study, and sign the informed consent

You may not qualify if:

• Wound non-healing, joint dislocation or unstable fracture fixation, pseudarthrosis, joint purulent infection and other contraindications for joint range of motion examination
• There are skin lesions, wounds or allergies to the coupling agent on the joint surface and other conditions that cannot be used for ultrasound examination

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Buwen Yao, PhD

CONTACT

15600555851; buwenyao@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 19, 2023
• Study Start: May 1, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2024
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)