Conservative Treatment of Early Adhesive Capsulitis

NCT06041282 | Recruiting

• 1 other identifier: 2023-0750
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Adhesive Capsulitis

Keywords

manipulation under anesthesia; supervised home rehabilitation

Outcome Measures

Primary Outcomes (1)

• Constant-Murley Score (CMS)

  The Constant-Mulery score mainly includes 8 aspects related to your shoulder in the past 4 weeks. The proportion of subjective and objective components in the Constant-Mulery score is 35 points/65 points. A total of 100 points.The subjective part of the score includes the score of pain degree and the score of impact on daily life. 35 points in total.The objective part of the score includes the score of shoulder range of motion and strength. 65 points in total.

  6months after intervention

Secondary Outcomes (8)

• Constant-Murley Score (CMS)

  1 months, 3months, and 1year after intervention

• Oxford Shoulder Score (OSS)

  1 months, 3months, 6 months and 1year after intervention

• Fear-avoidance belief questionnaire(FABQ)

  1 months, 3months, 6 months and 1year after intervention

• Insomnia Severity Index(ISI)

  1 months, 3months, 6 months and 1year after intervention

• Hospital Anxiety and Depression Scale(HADS)

  1 months, 3months, 6 months and 1year after intervention

Study Arms (2)

manipulation under anesthesia group

EXPERIMENTAL

The patient underwent manipulation under anesthesia

Procedure: manipulation under anesthesia

Supervised home rehabilitation group

ACTIVE COMPARATOR

The patient underwent supervised home rehabilitation

Procedure: supervised home rehabilitation

Interventions

manipulation under anesthesia 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.

manipulation under anesthesia group

supervised home rehabilitation 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.

Supervised home rehabilitation group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310058, China

RECRUITING

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Central Study Contacts

weiliang shen, doctor

CONTACT

+86 0571 87783759; wlshen@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 18, 2023
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

CN (1)