Ultrasound Imaging of Fibrotic Tissue

Recruiting

• Conditions: Arthrofibrosis of Knee; Arthrofibrosis of Shoulder
• Interventions: Other: Physical Therapy

• Registration Number: NCT05818904
• Lead Sponsor: Peking University Third Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-04-05
• Study First Posted: 2023-04-19
• Study Start: 2023-05-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-08
• Primary Completion: 2023-11-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Read More

Exclusion Criteria

1. Wound non-healing, joint dislocation or unstable fracture fixation, pseudarthrosis, joint purulent infection and other contraindications for joint range of motion examination
2. 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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arthrosis of knee	Physical Therapy	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.
arthrosis of shoulder	Physical Therapy	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.

Primary Outcome Measures

Name	Time	Method
KOOS score	3-month	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.
CM score	3-month	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.

Secondary Outcome Measures

Name	Time	Method
SF-36	3-month	The SF-36 (36-Item Short Form Survey) is a health questionnaire used to measure general health and well-being. It consists of 36 questions that evaluate eight domains, including physical functioning, role limitations, pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. The scale ranges from 0 to 100, with higher scores indicating better outcomes. The SF-36 survey is a widely used and reliable tool used in research and clinical practice to assess health status and well-being.
WOMAC	3-month	The WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) survey is a health questionnaire used to evaluate the severity of osteoarthritis in the knee and hip joints. It consists of 24 questions that evaluate three domains, including pain, stiffness, and physical function. The scale ranges from 0 to 96, with higher scores indicating worse outcomes. The WOMAC survey is a reliable and valid tool used in research and clinical practice to assess treatment effectiveness and track symptom changes over time.
HSS-KS	3-month	The HSS (Hospital for Special Surgery) survey is a health questionnaire used to assess patient outcomes after total hip or knee replacement surgery. It consists of 40 questions that evaluate patient pain, function, and satisfaction with the surgery. The scale ranges from 0 to 100, with higher scores indicating better outcomes. The HSS survey is a reliable and valid tool used in research and clinical practice to assess treatment effectiveness and track patient satisfaction and function over time.

Trial Locations

Locations (1)

Peking University Third Hospital; 🇨🇳 Beijing, China