A Multicentre Randomized Controlled Trial of Manipulation Under Anesthesia and Supervised Home Rehabilitation in the Treatment of Early Adhesive Capsulitis

Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country300 target enrollmentJanuary 1, 2026

ConditionsAdhesive Capsulitis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Adhesive Capsulitis
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Enrollment: 300
Locations: 1
Primary Endpoint: Constant-Murley Score (CMS)
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A prospective, multicentre, randomized controlled study comparing the efficacy of conservative treatment for early adhesive capsulitis

Detailed Description

This clinical trial evaluated the most common protocols for the treatment of adhesive capsulitis in secondary hospitals. To compare the efficacy of manipulation under anesthesia and supervised home conservative treatment of early adhesive capsulitis.

Registry

clinicaltrials.gov

Start Date

January 1, 2026

End Date

December 31, 2026

Last Updated

4 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients in our hospital who need manual release of periarthritis of shoulder or home rehabilitation treatment;
•Unilateral and primary periarthritis of shoulder
•Age ≥40 years old and ≤80 years old, regardless of gender.
•Forward flexion movement is more than 50% limited compared with the contralateral.
•Duration of disease ≤3 months

Exclusion Criteria

•Patients with a previous history of shoulder joint surgery
•Patients who did not complete the follow-up within the specified time
•Patients with other shoulder diseases.
•Patient with systemic immune disease.
•Patients who have participated in clinical trials or are conducting other clinical trials within 3 months before screening
•Patients with serious primary cardiovascular diseases, lung diseases, endocrine and metabolic diseases, or serious diseases affecting their survival, such as tumor or AIDS, are considered not suitable for admission.
•Patients with serious liver diseases, kidney diseases, hematological diseases, such as kidney function (BUN, Cr) more than the upper limit of normal, liver function (ALT, AST, TBIL) more than 2 times the upper limit of normal.
•Patients with viral hepatitis, infectious diseases, abnormal blood coagulation mechanism and other diseases that researchers consider inappropriate for surgery.
•Pregnant or lactating women, or those planning to get pregnant during the test, with positive urine HCG test results before the test; Menstruating women should wait until their period is over before undergoing surgery.
•Patients with severe neurological and mental diseases.

Outcomes

Primary Outcomes

Constant-Murley Score (CMS)

Time Frame: 6months after intervention

The Constant-Mulery score mainly includes 8 aspects related to your shoulder in the past 4 weeks. The proportion of subjective and objective components in the Constant-Mulery score is 35 points/65 points. A total of 100 points.The subjective part of the score includes the score of pain degree and the score of impact on daily life. 35 points in total.The objective part of the score includes the score of shoulder range of motion and strength. 65 points in total.

Secondary Outcomes

Constant-Murley Score (CMS)(1 months, 3months, and 1year after intervention)
Oxford Shoulder Score (OSS)(1 months, 3months, 6 months and 1year after intervention)
SF-36(1 months, 3months, 6 months and 1year after intervention)
Visual analogue scale(VAS)(1 months, 3months, 6 months and 1year after intervention)
Fear-avoidance belief questionnaire(FABQ)(1 months, 3months, 6 months and 1year after intervention)
Insomnia Severity Index(ISI)(1 months, 3months, 6 months and 1year after intervention)
Hospital Anxiety and Depression Scale(HADS)(1 months, 3months, 6 months and 1year after intervention)
range of motion(1 months, 3months, 6 months and 1year after intervention)