Shoulder Adhesive Capsulitis & Ambulatory Continuous Interscalene Nerve

Status Terminated

Clinical Trial Summary

Research study to determine if putting local anesthetic through a tiny tube next to the nerves that go to the shoulder will improve shoulder range-of-motion following the shoulder procedure performed on the frozen shoulder. It will also help determine if patients have a higher quality-of-life and less pain, require fewer pain pills, experience fewer sleep disturbances, and are more satisfied with their post-procedure pain control.

Clinical Trial Description

Primary Specific Aim: To determine if, compared with usual and customary analgesia, the addition of an ambulatory continuous interscalene nerve block will result in increased shoulder abduction following treatment for adhesive capsulitis of the shoulder.

Hypothesis: Following shoulder manipulation under a single-injection interscalene block for adhesive capsulitis, adding a three-day ambulatory continuous interscalene nerve blcok to usual and customary post-manipulation analgesia will result in a significantly greater shoulder abduction improvement the day following the manipulation.

Secondary Specific Aims: To determine if, compared with usual and customary analgesia, the addition of an ambulatory continuous interscalene nerve block will result in an increased quality-of-life and shoulder range-of-motion, as well as a decreased chronic pain following treatment for adhesive capsulitis of the shoulder.

Hypothesis 1: Following shoulder manipulation under a single-injection interscalene blcok for adhesive capsulitis, adding a three-day ambulatory continuous interscalene nerve block to usual and customary post-manipulation analgesia will result in a significantly increased quality-of-life improvement and shoulder range-of-motion compared wiht baseline values after three months.

Hypothesis 2: Following shoulder manipulation undera a single-injection interscalene block for adhesive capsulitis, adding a three-day ambulatory continuous interscalene nerve block to usual and costomary post-manipulation analgesia will result in a significantly decreased chronic pain compared with basedline falues after three months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00875862
Study type	Interventional
Source	University of California, San Diego
Contact
Status	Terminated
Phase	Phase 4
Start date	September 2008
Completion date	September 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms