Recruiting NCT06041282
Conservative Treatment of Early Adhesive Capsulitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: manipulation under anesthesia, supervised home rehabilitation.
- Who it may be relevant to
- Registry conditions: Adhesive Capsulitis. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Multicentre Randomized Controlled Trial of Manipulation Under Anesthesia and Supervised Home Rehabilitation in the Treatment of Early Adhesive Capsulitis
Overview
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.
Interventions
- 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. - 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 resis
Primary outcome measures
- Constant-Murley Score (CMS) [Time frame: 6months after intervention]
Secondary outcome measures (8)
- Constant-Murley Score (CMS) [Time frame: 1 months, 3months, and 1year after intervention]
- Oxford Shoulder Score (OSS) [Time frame: 1 months, 3months, 6 months and 1year after intervention]
- Fear-avoidance belief questionnaire(FABQ) [Time frame: 1 months, 3months, 6 months and 1year after intervention]
- Insomnia Severity Index(ISI) [Time frame: 1 months, 3months, 6 months and 1year after intervention]
- Hospital Anxiety and Depression Scale(HADS) [Time frame: 1 months, 3months, 6 months and 1year after intervention]
- SF-36 [Time frame: 1 months, 3months, 6 months and 1year after intervention]
- Visual analogue scale(VAS) [Time frame: 1 months, 3months, 6 months and 1year after intervention]
- range of motion [Time frame: 1 months, 3months, 6 months and 1year after intervention]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou
Identifiers
NCT: NCT06041282 · 2023-0750