Carpal Tunnel Syndrome Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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