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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Other: group A: HYPERTHERMIA
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group a: Hyperthermia (HT)<br>HT were treated for 20 minutes per session, a total of 8 sessions with device; | Other: group A: HYPERTHERMIA<br>* 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<br>* Other names: HT produce heating.;|
| No Intervention: group b: No intervention<br>device was switched in off, only bolus was active | Other: No intervention<br>* the intervention tool was switched in off, only bolus was activated<br>* Other names: simulated intervention;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcome is visual analogic scale for pain (VAS) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |