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

Not Applicable

Completed

• Conditions: Adhesive Capsulitis
• Interventions: Procedure: Capsule-Preserving Intra-articular Hydraulic Distension; Procedure: Capsule-Rupturing Intra-articular Hydraulic Distension

• Registration Number: NCT00992927
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-10-07
• Study First Submitted QC: 2009-10-08
• Study First Posted: 2009-10-09
• Primary Completion: 2010-05
• Study Completion: 2010-08
• Results First Submitted: 2010-08-15
• Status Verified: 2011-07
• Results First Submitted QC: 2011-07-21
• Last Update Submitted: 2011-07-21
• Results First Posted: 2011-08-17
• Last Update Posted: 2011-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPIHD	Capsule-Preserving Intra-articular Hydraulic Distension	Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
CRIHD	Capsule-Rupturing Intra-articular Hydraulic Distension	Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.

Primary Outcome Measures

Name	Time	Method
Range of Motion (ROM) of the Glenohumeral Joint	1 month	1. before intervention for all participants; 2. using a goniometer; 3. patient sitting on a stool with the arm at anatomical position; 4. worst: 0 degree; 5. best: 360 degree

Secondary Outcome Measures

Name	Time	Method
Pain Measured by Visual Analogue Scale (VAS)	1 month	1. before intervention for all participants; 2. using 10cm horizontal visual analog scale; 3. best: 0cm (no pain); 4. worst: 10cm (worst pain)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of