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Hyperthermia As A Conservative Treatment For Carpal Tunnel Syndrome. A Randomized "Sham" Controlled Trial

NCT00988923 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2009-10-02

No results posted yet for this study

Summary

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).

Conditions

  • Carpal Tunnel Syndrome

Interventions

OTHER

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

OTHER

No intervention

the intervention tool was switched in off, only bolus was activated

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Giuseppina Frasca, MD · Rehabilitation Department, Catholic University, Rome

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00988923 on ClinicalTrials.gov