Conservative Treatment of Early Adhesive Capsulitis

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

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

Study Overview

• Status: Recruiting
• Conditions: Adhesive Capsulitis
• Intervention / Treatment: Procedure: manipulation under anesthesia; Procedure: supervised home rehabilitation

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: weiliang shen, doctor; Phone Number: +86 0571 87783759; Email: wlshen@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310058
      • Recruiting
      • 2nd Affiliated Hospital, School of Medicine, Zhejiang University
      • Contact: weiliang shen, Doctor; Phone Number: 86-0571-86995513; Email: wlshen@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: manipulation under anesthesia group; The patient underwent manipulation under anesthesia	Procedure: 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.
Active Comparator: Supervised home rehabilitation group; The patient underwent supervised home rehabilitation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 months, 3months, and 1year after intervention
Oxford Shoulder Score (OSS)	The Oxford Shoulder Score (OSS) consists of 12 questions with five options each. The light to heavy lines were assigned 1, 2, 3, 4 and 5 points respectively. So the total score is between 12 and 60. A score of 12 represents perfectly normal shoulder function and a score of 60 represents the most severe difficulty in shoulder function.	1 months, 3months, 6 months and 1year after intervention
Fear-avoidance belief questionnaire(FABQ)	The FABQ is a self-assessment scale with 16 options. Each option has 0~6 points and 7 grades (from extremely disagreeable to extremely agreed). "0" means completely disagreed, "6" means completely agreed, and "1~5" means not sure. The higher the score, the more inclined to fully agree	1 months, 3months, 6 months and 1year after intervention
Insomnia Severity Index(ISI)	The scale is a simple tool for screening insomnia, including 7 items, which are used to evaluate the nature and symptoms of sleep disorders of subjects.	1 months, 3months, 6 months and 1year after intervention
Hospital Anxiety and Depression Scale(HADS)	HADS is a self-assessment scale, including two subscales, HADS-A and HADS-D, with a total of 14 items, including 7 items for anxiety (A) and 7 items for depression (D). Each item is scored at four levels according to the frequency of symptoms in the past month. Each item is scored at 0-3 points in four levels. The higher the score, the more serious the anxiety or depression	1 months, 3months, 6 months and 1year after intervention
SF-36	SF-36 is a concise health questionnaire developed by the Boston Institute of Health, which is widely used in the measurement of the quality of life of the general population, the evaluation of clinical trials and the evaluation of health policies. SF-36 is used to assess physiological function, physiological function, physical pain, general health, energy, social function, emotional function and mental health, which are classified into "physical health" and "mental health"	1 months, 3months, 6 months and 1year after intervention
Visual analogue scale(VAS)	Draw a 10cm horizontal line on the paper. One end of the line is "0", indicating no pain; the other end is "10", indicating severe pain; The middle represents different degrees of pain; Let the patient draw a mark on the horizontal line according to their feelings to indicate the degree of pain.	1 months, 3months, 6 months and 1year after intervention
range of motion	Measure the patient's flexion, abduction, internal rotation and external rotation angle	1 months, 3months, 6 months and 1year after intervention

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 5, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: manipulation under anesthesia; supervised home rehabilitation
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 2023-0750

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No