RecruitingNot ApplicableNCT06041282

Conservative Treatment of Early Adhesive Capsulitis

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

300 participants

Start Date

Jan 1, 2026

Study Type

INTERVENTIONAL

Conditions

Adhesive Capsulitis

Summary

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

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Inclusion Criteria5

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 Criteria11

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.
Suspected or true history of alcohol and drug abuse.

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Interventions

PROCEDUREmanipulation under anesthesia

After the anesthesia took effect, the patient was placed in the supine position, and the experienced surgeon stood at the head of the bed to release the affected limb by four angles of forward flexion, abduction, external rotation and internal rotation. After the operation is completed, 1ml de Bosson (MSD) +2.5ml sodium hyaluronate (Biochemical Industries Co., LTD.) is injected once.

PROCEDUREsupervised home rehabilitation

The doctor instructs the patient in exercise training at the outpatient clinic. At each clinic visit, the doctor will guide the different stages of the movement. At the first visit, the doctor guides the patient through the first phase of the rehabilitation program to improve the patient's basic mobility. At the first month of follow-up, the second phase of rehabilitation program was guided, and the recovery of mobility was accompanied by muscle training, including wall climbing and muscle resistance exercises. 1ml Debossone (MSD) +2.5ml sodium hyaluronate (Biochemical Industries Co., LTD.) was injected once at the clinic. All the training required patients to do their best at home to complete 3 sets of 5 each. At the end of each day, the patient will upload a video to the platform, and the doctor will evaluate whether the patient's recovery is in place.