Conservative Treatment of Early Adhesive Capsulitis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • manipulation under anesthesia

    Procedure/Surgery

    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.

  • supervised home rehabilitation

    Procedure/Surgery

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: manipulation under anesthesia groupExperimental treatment 1 intervention
Group B: Supervised home rehabilitation groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
6months after intervention

Secondary outcomes

1

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.

Time frame
1 months, 3months, and 1year after intervention
2

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.

Time frame
1 months, 3months, 6 months and 1year after intervention
3

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

Time frame
1 months, 3months, 6 months and 1year after intervention
4

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.

Time frame
1 months, 3months, 6 months and 1year after intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.