Conservative Treatment of Early Adhesive Capsulitis

NCT ID: NCT06041282

Last Updated: 2026-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Adhesive Capsulitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

manipulation under anesthesia group

The patient underwent manipulation under anesthesia

Group Type EXPERIMENTAL

manipulation under anesthesia

Intervention Type PROCEDURE

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.

Supervised home rehabilitation group

The patient underwent supervised home rehabilitation

Group Type ACTIVE_COMPARATOR

supervised home rehabilitation

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

manipulation 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.

Intervention Type PROCEDURE

supervised 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

weiliang shen, doctor

Role: CONTACT

+86 0571 87783759

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

weiliang shen, Doctor

Role: primary

86-0571-86995513

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-0750

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.