ARTHRO Distension Plus Intensive Mobilisation in Shoulder Capsulitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the effectiveness of ARTHRO distension plus intensive mobilisation in shoulder capsulitis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect Of Instrumented Assisted Soft Tissue Mobilization On Pain, Function And Proprioception In Patients With Shoulder Impingement Syndrome

NCT05546177

Shoulder Impingement

UNKNOWN NA

Ambulatory Rehabilitation Program in Patients With Degenerative Rupture of the Rotator Cuff Tendons of the Shoulder

NCT05413213

Shoulder Pain

UNKNOWN NA

Effectiveness of Surgery for Atraumatic Shoulder Instability

NCT01751490

Atraumatic Shoulder Instability

COMPLETED NA

Influence of an Anterior Latarjet-type Abutment Operation on Scapular Dyskinesia and the Muscular Stabilization Mechanisms of the Scapula (DyScapLat)

NCT05131126

Latarjet Scapular Dyskinesis

UNKNOWN NA

Application of an Exercise Program Versus Exercise Plus Manual Therapy in the Treatment of Adhesive Capsulitis.

NCT06497348

Capsulitis of Shoulder Frozen Shoulder

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The aim of the study is to evaluate a treatment of shoulder capsulitis that associates ARTHRO distension and intensive mobilisation at 2, 6, 12, 26 and 52 weeks. It is a bicentric 87-month (inclusion: 74 months; follow up: 13 months) observer blind randomised clinical trial using 2 groups in parallel. The number of patients to be included is 66. The treatment that is evaluated associates ARTHRO distension followed by mobilisation of the shoulder 6 hours per day during 5 days, and then sessions of physiotherapy for 4 weeks. The control intervention is one intra-articular injection of corticosteroids and physiotherapy. The primary outcome is SPADI, namely pain and disability, at 2 weeks.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Shoulder Capsulitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

infiltration intra articular

Group Type ACTIVE_COMPARATOR

infiltration intra articular

Intervention Type PROCEDURE

infiltration intra articular at inclusion with XYLOCAINE 1%

2

ARTHRO distension plus intensive mobilisation

Group Type EXPERIMENTAL

ARTHRO distension plus intensive mobilisation

Intervention Type PROCEDURE

ARTHRO distension plus intensive mobilisation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

infiltration intra articular

infiltration intra articular at inclusion with XYLOCAINE 1%

Intervention Type PROCEDURE

ARTHRO distension plus intensive mobilisation

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

infiltration intra articular at inclusion with XYLOCAINE 1%

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age ≥ 18 years
* shoulder capsulitis
* duration of symptoms ≥ 3 months
* health insurance

Exclusion Criteria

* cognitive disorders
* Hypo coagulation
* biological inflammatory syndrome
* uncontrolled diabetes
* XYLOCAINE allergy
* pregnancy
* unable to understand and to speak french
* previous surgery of shoulder
* shoulder infiltration or distension in the previous month
* local contraindication to shoulder infiltration

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No