Collagenase in the Treatment of Adhesive Capsulitis (Frozen Shoulder)

Stony Brook University

Status and phase: Withdrawn; Phase 2

Conditions: Frozen Shoulder; Adhesive Capsulitis

Treatments: Drug: Collagenase

Study type: Interventional

Funder types: Other

Identifiers

NCT00261196

Shoulder 202

Details and patient eligibility

About

The purpose of this study is to test collagenase injection therapy to dissolve adhesions causing frozen shoulder.

Full description

In a random, placebo controlled, double blind study, collagenase injection therapy will be investigated for it's ability to lyse the adhesions associated with the shoulder capsule in adhesive capsulitis (frozen shoulder).

Treatment success may obviate the need for extensive physical therapy and/or shoulder arthroscopy (surgery) to correct this condition and restore normal and pain free shoulder motion.

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of frozen shoulder of at least one month duration

Exclusion criteria

• shoulder arthritis
• rotator cuff tears
• any chronic, serious, uncontrolled medical condition
• inability to conform to study visits (20-30 per year)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Collagenase

Experimental group

Description:

Collagenase Injection

Treatment:

Drug: Collagenase

Placebo

Placebo Comparator group

Description:

Placebo Injection

Treatment:

Drug: Collagenase