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

June 12, 2009
October 1, 2009
October 2007
September 2008   (final data collection date for primary outcome measure)
Primary outcome is visual analogic scale for pain (VAS) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00988923 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Hyperthermia As A Conservative Treatment For Carpal Tunnel Syndrome. A Randomized "Sham" Controlled Trial
Hyperthermia As A Conservative Treatment For Carpal Tunnel Syndrome. A Randomized "Sham" Controlled Trial

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Carpal Tunnel Syndrome
  • 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.
  • Other: No intervention
    the intervention tool was switched in off, only bolus was activated
    Other Name: simulated intervention
  • Experimental: group a: Hyperthermia (HT)
    HT were treated for 20 minutes per session, a total of 8 sessions with device;
    Intervention: Other: group A: HYPERTHERMIA
  • No Intervention: group b: No intervention
    device was switched in off, only bolus was active
    Intervention: Other: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
September 2008
September 2008   (final data collection date for primary outcome measure)

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.
Both
45 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00988923
1198/07
No
Giuseppina Frasca-Physical Medicine and Rehabilitation Department, Catholic University
Catholic University of the Sacred Heart
Not Provided
Principal Investigator: Giuseppina Frasca, MD Rehabilitation Department, Catholic University, Rome
Catholic University of the Sacred Heart
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP