Conservative Treatment of Early Adhesive Capsulitis

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

manipulation under anesthesia

supervised home rehabilitation

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring manipulation under anesthesia, supervised home rehabilitation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

manipulation under anesthesia group

Supervised home rehabilitation group

Arm Description

The patient underwent manipulation under anesthesia

The patient underwent supervised home rehabilitation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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

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.

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

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"

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.

range of motion

Measure the patient's flexion, abduction, internal rotation and external rotation angle

Full Information

NCT ID

NCT06041282

First Posted

September 11, 2023

Last Updated

October 5, 2023

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

1. Study Identification

Unique Protocol Identification Number

NCT06041282

Brief Title

Conservative Treatment of Early Adhesive Capsulitis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 30, 2023 (Anticipated)

Primary Completion Date

December 31, 2025 (Anticipated)

Study Completion Date

December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adhesive Capsulitis

Keywords

manipulation under anesthesia, supervised home rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

manipulation under anesthesia group

Arm Type

Experimental

Arm Description

The patient underwent manipulation under anesthesia

Arm Title

Supervised home rehabilitation group

Arm Type

Active Comparator

Arm Description

The patient underwent supervised home rehabilitation

Intervention Type

Procedure

Intervention Name(s)

manipulation under anesthesia

Intervention Description

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

Intervention Name(s)

supervised home rehabilitation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Constant-Murley Score (CMS)

Description

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.

Time Frame

6months after intervention

Secondary Outcome Measure Information:

Title

Constant-Murley Score (CMS)

Description

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.

Time Frame

1 months, 3months, and 1year after intervention

Title

Oxford Shoulder Score (OSS)

Description

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.

Time Frame