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

Seoul National University

Status: Completed

Conditions: Adhesive Capsulitis

Treatments: Procedure: Capsule-Rupturing Intra-articular Hydraulic Distension; Procedure: Capsule-Preserving Intra-articular Hydraulic Distension

Study type: Interventional

Funder types: Other

Identifiers

NCT00992927

SNUH-RM-SGChung-IHD-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups

CPIHD

Experimental group

Description:

Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.

Treatment:

Procedure: Capsule-Preserving Intra-articular Hydraulic Distension

CRIHD

Active Comparator group

Description:

Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.

Treatment:

Procedure: Capsule-Rupturing Intra-articular Hydraulic Distension