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

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Other: No intervention

• Registration Number: NCT00988923
• Lead Sponsor: Catholic University of the Sacred Heart

Brief 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).

Detailed Description

Background: Non-surgical treatment is generally administered to patients with mild to moderate symptoms. Many of these treatments used heat modality. Hyperthermia is a relative recent device which produces deep heating.

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.

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2009-06-12
• Status Verified: 2009-10
• Study First Submitted QC: 2009-10-01
• Last Update Submitted: 2009-10-01
• Study First Posted: 2009-10-02
• Last Update Posted: 2009-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Bilateral or unilateral mild to moderate carpal tunnel syndrome confirmed by clinical and neurophysiological tests, with no indication to surgical intervention.
• 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

• Secondary entrapment neuropathies (diabetes, systemic disease)
• Cancer, pregnancy
• Electroneurographic and clinical signs of axonal degeneration of the median nerve.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group b: No intervention	No intervention	device was switched in off, only bolus was active

Primary Outcome Measures

Name	Time	Method
Primary outcome is visual analogic scale for pain (VAS)	4 weeks

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation,; 🇮🇹 Roma, Rome, Italy