Clinical trial NCT06041282: 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
Overall status: RECRUITING
Phase: NA
Conditions: Adhesive Capsulitis
Keywords: manipulation under anesthesia
supervised home rehabilitation
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 300
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Constant-Murley Score (CMS)
timeFrame: 6months after intervention
Secondary outcomes:
measure: Constant-Murley Score (CMS)
timeFrame: 1 months, 3months, and 1year after intervention
measure: Oxford Shoulder Score (OSS)
timeFrame: 1 months, 3months, 6 months and 1year after intervention
measure: Fear-avoidance belief questionnaire(FABQ)
timeFrame: 1 months, 3months, 6 months and 1year after intervention
measure: Insomnia Severity Index(ISI)
timeFrame: 1 months, 3months, 6 months and 1year after intervention
measure: Hospital Anxiety and Depression Scale(HADS)
timeFrame: 1 months, 3months, 6 months and 1year after intervention
measure: SF-36
timeFrame: 1 months, 3months, 6 months and 1year after intervention
measure: Visual analogue scale(VAS)
timeFrame: 1 months, 3months, 6 months and 1year after intervention
measure: range of motion
timeFrame: 1 months, 3months, 6 months and 1year after intervention
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: