Treatment options for early adhesive capsulitis

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

This study is testing whether manipulation under anesthesia or supervised home rehabilitation works better for people with early adhesive capsulitis to improve their shoulder movement.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 40 Years to 80 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06041282 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of two conservative treatment approaches for early adhesive capsulitis: manipulation under anesthesia and supervised home rehabilitation. It is a multicenter, randomized controlled study that aims to determine which method provides better outcomes for patients suffering from this condition. The trial focuses on patients who have a significant limitation in shoulder movement and have had the condition for less than three months.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 40 to 80 with unilateral primary adhesive capsulitis and significant movement limitations.

Not a fit: Patients with a history of shoulder surgery, other shoulder diseases, or serious systemic conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide patients with effective treatment options that improve shoulder mobility and reduce pain.

How similar studies have performed: Previous studies have shown varying success with similar conservative treatment approaches for adhesive capsulitis, but this specific comparison is novel.

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

Where this trial is running

Hangzhou, Zhejiang

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: weiliang shen, doctor

Conditions Adhesive Capsulitis; manipulation under anesthesia; supervised home rehabilitation