Should the Joint Capsule of the Painful Stiff Shoulder be Ruptured During Intra-articular Hydraulic Distension?

Study Overview
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Brief Summary
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The purpose of the study is to compare the efficacy of intra-articular hydraulic distension (IHD) for the treatment of painful stiff shoulders between capsule-rupturing and capsule-preserving IHDs.

Detailed Description
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The Painful stiff shoulder (PSS), or the adhesive capsulitis, involves stiff and contracted joint capsule from fibrosis in the glenohumeral joint. Intra-articular hydraulic distension (IHD) enlarges the stiffened capsule by deforming it with excessive volume and pressure within the joint space. Although IHD is one of the most common treatment options for the PSS, the diversity of the IHD technique spans wide range. Specifically, it is not generally agreed as for which, between capsule-rupturing and capsule-preserving IHDs, is superior for PSS treatment. Capsule-preserving IHD might fail to infuse sufficient amount of fluid to avoid rupture, thus producing less satisfactory outcomes. However, we devised in our previous study a novel technique that enabled a physician to infuse the possible largest volume without rupturing the capsule. By employing the technique, we aim to compare the clinical efficacy of capsule-rupturing versus capsule-preserving IHDs in patients with PSSs.

Official Title
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Comparative Study for the Efficacy of Capsule-Preserving Versus Capsule-Rupturing Intra-articular Hydraulic Distension in Patients With Painful Stiff Shoulders

Conditions
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Adhesive Capsulitis

Intervention / Treatment
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* Procedure: Capsule-Preserving Intra-articular Hydraulic Distension
* Procedure: Capsule-Rupturing Intra-articular Hydraulic Distension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: shoulder discomfort for at least one month limited range of motion of the glenohumeral joint in at least two directions Exclusion Criteria: systemic inflammatory joint disease radiological evidence of bony abnormality of the shoulder full-thickness rotator cuff tear acute systemic medical illness history of major trauma or surgery involving the shoulder contraindication to intra-articular, local anesthestic injection

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPIHD<br>Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule. | Procedure: Capsule-Preserving Intra-articular Hydraulic Distension<br>* Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.<br>|
| Active Comparator: CRIHD<br>Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed. | Procedure: Capsule-Rupturing Intra-articular Hydraulic Distension<br>* Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion (ROM) of the Glenohumeral Joint | before intervention for all participants using a goniometer patient sitting on a stool with the arm at anatomical position worst: 0 degree best: 360 degree | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Measured by Visual Analogue Scale (VAS) | before intervention for all participants using 10cm horizontal visual analog scale best: 0cm (no pain) worst: 10cm (worst pain) | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Injections, Intra-Articular, Range of Motion, Articular, Pain