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

NCT00988923 | Completed

• 1 other identifier: 1198/07
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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).

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Primary outcome is visual analogic scale for pain (VAS)

  4 weeks

Secondary Outcomes (1)

• 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

Study Arms (2)

group a: Hyperthermia (HT)

EXPERIMENTAL

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

Other: group A: HYPERTHERMIA

group b: No intervention

NO INTERVENTION

device was switched in off, only bolus was active

Other: No intervention

Interventions

group A: HYPERTHERMIA OTHER

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

Also known as: HT produce heating.

group a: Hyperthermia (HT)

No intervention OTHER

the intervention tool was switched in off, only bolus was activated

Also known as: simulated intervention

group b: No intervention

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation,

Roma, Rome, 00168, Italy

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Giuseppina Frasca, MD

  Rehabilitation Department, Catholic University, Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 12, 2009
• First Posted: October 2, 2009
• Study Start: October 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: October 2, 2009

Record last verified: 2009-10

Locations

IT (1)