Conservative Treatment of Early Adhesive Capsulitis

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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

Первичные конечные точки

• Constant-Murley Score (CMS) [Срок оценки: 6months after intervention]

Вторичные конечные точки (8)

• Constant-Murley Score (CMS) [Срок оценки: 1 months, 3months, and 1year after intervention]
• Oxford Shoulder Score (OSS) [Срок оценки: 1 months, 3months, 6 months and 1year after intervention]
• Fear-avoidance belief questionnaire(FABQ) [Срок оценки: 1 months, 3months, 6 months and 1year after intervention]
• Insomnia Severity Index(ISI) [Срок оценки: 1 months, 3months, 6 months and 1year after intervention]
• Hospital Anxiety and Depression Scale(HADS) [Срок оценки: 1 months, 3months, 6 months and 1year after intervention]
• SF-36 [Срок оценки: 1 months, 3months, 6 months and 1year after intervention]
• Visual analogue scale(VAS) [Срок оценки: 1 months, 3months, 6 months and 1year after intervention]
• range of motion [Срок оценки: 1 months, 3months, 6 months and 1year after intervention]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Ханчжоу

Идентификаторы

NCT: NCT06041282 · 2023-0750

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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