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

This study has been completed.
Sponsor:
Information provided by:
Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier:
NCT00988923
First received: June 12, 2009
Last updated: October 1, 2009
Last verified: October 2009
History of Changes
  Purpose

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 Intervention
Carpal Tunnel Syndrome
 Other: group A: HYPERTHERMIA
Other: No intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Hyperthermia As A Conservative Treatment For Carpal Tunnel Syndrome. A Randomized "Sham" Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Catholic University of the Sacred Heart:

Primary Outcome Measures:
  • Primary outcome is visual analogic scale for pain (VAS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: October 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Giuseppina Frasca-Physical Medicine and Rehabilitation Department, Catholic University
ClinicalTrials.gov Identifier: NCT00988923     History of Changes
Other Study ID Numbers: 1198/07
Study First Received: June 12, 2009
Last Updated: October 1, 2009
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Fever
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

ClinicalTrials.gov processed this record on May 21, 2013