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

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ClinicalTrials.gov Identifier: NCT00988923
Recruitment Status : Completed
First Posted : October 2, 2009
Last Update Posted : October 2, 2009
Sponsor:
Information provided by:
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).


Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Other: group A: HYPERTHERMIA Other: No intervention Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyperthermia As A Conservative Treatment For Carpal Tunnel Syndrome. A Randomized "Sham" Controlled Trial
Study Start Date : October 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008


Arm Intervention/treatment
Experimental: group a: Hyperthermia (HT)
HT were treated for 20 minutes per session, a total of 8 sessions with device;
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 Name: HT produce heating.
No Intervention: group b: No intervention
device was switched in off, only bolus was active
Other: No intervention
the intervention tool was switched in off, only bolus was activated
Other Name: simulated intervention



Primary Outcome Measures :
  1. Primary outcome is visual analogic scale for pain (VAS) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Secondary outcomes were self-reported pain intensity and physical functioning questionnaire (Levine/Boston), ultrasonographic (median nerve cross sectional area (mnCSA) and neurophysiological data [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   45 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00988923


Locations
Italy
Department of Physical Medicine and Rehabilitation,
Roma, Rome, Italy, 00168
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Giuseppina Frasca, MD Rehabilitation Department, Catholic University, Rome

Responsible Party: Giuseppina Frasca-Physical Medicine and Rehabilitation Department, Catholic University
ClinicalTrials.gov Identifier: NCT00988923     History of Changes
Other Study ID Numbers: 1198/07
First Posted: October 2, 2009    Key Record Dates
Last Update Posted: October 2, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Fever
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries
Body Temperature Changes
Signs and Symptoms