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

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
group A: HYPERTHERMIA
No intervention
Sponsored by
Catholic University of the Sacred Heart
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Physical Medicine and Rehabilitation,

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

group a: Hyperthermia (HT)

group b: No intervention

Arm Description

HT were treated for 20 minutes per session, a total of 8 sessions with device;

device was switched in off, only bolus was active

Outcomes

Primary Outcome Measures

Primary outcome is visual analogic scale for pain (VAS)

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

Full Information

First Posted
June 12, 2009
Last Updated
October 1, 2009
Sponsor
Catholic University of the Sacred Heart
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1. Study Identification

Unique Protocol Identification Number
NCT00988923
Brief Title
Hyperthermia As A Conservative Treatment For Carpal Tunnel Syndrome. A Randomized "Sham" Controlled Trial
Official Title
Hyperthermia As A Conservative Treatment For Carpal Tunnel Syndrome. A Randomized "Sham" Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Catholic University of the Sacred Heart

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group a: Hyperthermia (HT)
Arm Type
Experimental
Arm Description
HT were treated for 20 minutes per session, a total of 8 sessions with device;
Arm Title
group b: No intervention
Arm Type
No Intervention
Arm Description
device was switched in off, only bolus was active
Intervention Type
Other
Intervention Name(s)
group A: HYPERTHERMIA
Other Intervention Name(s)
HT produce heating.
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
No intervention
Other Intervention Name(s)
simulated intervention
Intervention Description
the intervention tool was switched in off, only bolus was activated
Primary Outcome Measure Information:
Title
Primary outcome is visual analogic scale for pain (VAS)
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppina Frasca, MD
Organizational Affiliation
Rehabilitation Department, Catholic University, Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation,
City
Roma
State/Province
Rome
ZIP/Postal Code
00168
Country
Italy

12. IPD Sharing Statement

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

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