NCT00988923|Completed
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Sponsor study identifier
interventional
34
1 country
1
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)The purpose of this study is to verify the short-term effects of hyperthermia (HT) in pain relief and in functional impairment in patients affected by mild to moderate idiopathic carpal tunnel syndrome. A single blind randomized sham-controlled trial was performed. A 23 patients were affected by idiopathic CTS, 11 of them were affected by bilateral CTS. the intervention consists of Hyperthermia device treatment, treated for 20 minutes per session, a total of 8 sessions. Primary outcome is pain (Visual analogic scale).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2008
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
September 2008
Actual (reported)September 2008
Actual (reported)June 12, 2009
Actual (reported)October 2, 2009
Actual (reported)Primary outcome is visual analogic scale for pain (VAS)
4 weeks
Secondary outcomes were self-reported pain intensity and physical functioning questionnaire (Levine/Boston), ultrasonographic (median nerve cross sectional area (mnCSA) and neurophysiological data
4 weeks
HT were treated for 20 minutes per session, a total of 8 sessions with device;
device was switched in off, only bolus was active
All patients were treated for 8 sessions, twice a week, for a total of 4 weeks of treatment. All patients were evaluated at baseline (T0) and after 4 weeks (T1). The first two sessions were sham-treatment for both groups
the intervention tool was switched in off, only bolus was activated
Department of Physical Medicine and Rehabilitation,
Roma, Rome, 00168, Italy
Giuseppina Frasca, MD
Rehabilitation Department, Catholic University, Rome
34 participants (actual enrollment reported by the registry).
First Submitted
June 12, 2009
First Posted
October 2, 2009
Study Start
October 2007
Date type not reportedThis date has not been verified as actual or estimated.
Post-operative Mobilization for Carpal Tunnel Syndrome
Patient Outcomes With Endoscopic Versus Open Carpal Tunnel Release
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Primary Completion
September 2008
Actual (reported)Study Completion
September 2008
Actual (reported)Last Updated
October 2, 2009
Record last verified: 2009-10
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Source: ClinicalTrials.gov.
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