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OpenTrials
Completed

NCT Number: NCT00992927

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

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.

Completed

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Capsule-Preserving Intra-articular Hydraulic Distension

Procedure

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

Capsule-Rupturing Intra-articular Hydraulic Distension

Procedure

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

Primary outcomes

  1. Range of Motion (ROM) of the Glenohumeral Joint

    Time frame: 1 month

    • 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

Secondary outcomes

  1. Pain Measured by Visual Analogue Scale (VAS)

    Time frame: 1 month

    • before intervention for all participants
    • using 10cm horizontal visual analog scale
    • best: 0cm (no pain)
    • worst: 10cm (worst pain)

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Oct 9, 2009
Registry last updated
Aug 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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