Actively Recruiting

Phase Not Applicable
Age: 40Years - 80Years
All Genders
ID06041282

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

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-01-02

300

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of two common treatments for early adhesive capsulitis, also known as frozen shoulder, in a multicenter randomized controlled trial. The study compares manipulation under anesthesia with supervised home rehabilitation to determine which approach better improves shoulder function and reduces symptoms. The trial is conducted in secondary hospitals and sponsored by the Second Affiliated Hospital, School of Medicine, Zhejiang University. Participants are randomly assigned to one of two groups. In the manipulation under anesthesia group, patients undergo a procedure where an experienced surgeon moves the shoulder through various angles under anesthesia, followed by an injection of medication. In the supervised home rehabilitation group, patients receive guided exercise training at outpatient visits with phased progression, including mobility and muscle resistance exercises, plus an injection at the clinic. Patients upload daily videos to a platform for doctor evaluation to monitor their recovery. Throughout the study, participants undergo assessments of shoulder function using the Constant-Murley Score at multiple time points up to one year after treatment. Additional measures include the Oxford Shoulder Score, fear-avoidance beliefs, insomnia severity, anxiety and depression scales, quality of life surveys (SF-36), pain ratings, and range of motion. These evaluations help researchers monitor progress, adherence, and safety. The study lasts at least one year with follow-up visits to assess long-term outcomes.

CONDITIONS

Brief Title

Conservative Treatment of Early Adhesive Capsulitis

Who Can Participate

Age: 40Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients needing manual release of periarthritis of shoulder or home rehabilitation treatment
  • Unilateral and primary periarthritis of shoulder
  • Age between 40 and 80 years, any gender
  • Forward flexion movement limited by more than 50% compared with the opposite shoulder
  • Disease duration of 3 months or less
Not Eligible

You will not qualify if you...

  • Previous history of shoulder joint surgery
  • Incomplete follow-up within the specified time
  • Other shoulder diseases
  • Systemic immune diseases
  • Participation in other clinical trials within 3 months before screening
  • Serious cardiovascular, lung, endocrine, metabolic diseases, or life-threatening conditions like tumor or AIDS
  • Serious liver, kidney, or blood diseases exceeding normal limits
  • Viral hepatitis, infectious diseases, or abnormal blood clotting
  • Pregnant, lactating, or planning pregnancy during the study; menstruating women must wait for period to end before surgery
  • Severe neurological or mental diseases
  • History or suspicion of alcohol or drug abuse

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 1 year

Participants receive either manipulation under anesthesia or supervised home rehabilitation to treat early adhesive capsulitis.

Initial treatment visit plus follow-up visits at 1 month, 3 months, 6 months, and 1 year

Trial Site Locations

Total: 1 location

1

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China, 310058

Actively Recruiting

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Research Team

W

weiliang shen, doctor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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