Hyperthermia As A Conservative Treatment For Carpal Tunnel Syndrome. A Randomized "Sham" Controlled Trial
NCT ID: NCT00988923
Last Updated: 2009-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
34 participants
INTERVENTIONAL
2007-10-31
2008-09-30
Brief Summary
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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).
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Detailed Description
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Objective: 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.
Design: A double blind randomized sham-controlled trial. Setting: Outpatient physical therapy, institutional clinic. Participants: 23 patients were affected by idiopathic CTS, 11 of them were affected by bilateral CTS.
Intervention: Hyperthermia (HT) device treatment, treated for 20 minutes per session, a total of 8 sessions.
Measurement: Primary outcome is pain (Visual analogic scale). Secondary outcomes were self-reported pain intensity and physical functioning questionnaire (Levine/Boston), ultrasonographic (median nerve cross sectional area mnCSA) and neurophysiological data.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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group a: Hyperthermia (HT)
HT were treated for 20 minutes per session, a total of 8 sessions with device;
group A: HYPERTHERMIA
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
group b: No intervention
device was switched in off, only bolus was active
No intervention
the intervention tool was switched in off, only bolus was activated
Interventions
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group A: HYPERTHERMIA
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
No intervention
the intervention tool was switched in off, only bolus was activated
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* All patients were grouped into first, second and third classes according to Historic and Objective (Hi-Ob)15 scale of CTS and minimum, mild CTS according to the neurophysiological classification of Padua1
Exclusion Criteria
* Cancer, pregnancy
* Electroneurographic and clinical signs of axonal degeneration of the median nerve.
45 Years
75 Years
ALL
No
Sponsors
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Catholic University of the Sacred Heart
OTHER
Responsible Party
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Catholic University
Principal Investigators
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Giuseppina Frasca, MD
Role: PRINCIPAL_INVESTIGATOR
Rehabilitation Department, Catholic University, Rome
Locations
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Department of Physical Medicine and Rehabilitation,
Roma, Rome, Italy
Countries
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Other Identifiers
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1198/07
Identifier Type: -
Identifier Source: org_study_id
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