Conservative Treatment of Early Adhesive Capsulitis

Zhejiang University

Status: Enrolling

Conditions: Adhesive Capsulitis

Treatments: Procedure: supervised home rehabilitation; Procedure: manipulation under anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT06041282

2023-0750

Details and patient eligibility

About

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

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.
• Suspected or true history of alcohol and drug abuse.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

manipulation under anesthesia group

Experimental group

Description:

The patient underwent manipulation under anesthesia

Treatment:

Procedure: manipulation under anesthesia

Supervised home rehabilitation group

Active Comparator group

Description:

The patient underwent supervised home rehabilitation

Treatment:

Procedure: supervised home rehabilitation