Continuous And Pulsed Ultrasound Treatments On Carpal Tunnel Syndrome

NCT ID: NCT02054247

Last Updated: 2023-11-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-06-30

Brief Summary

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The aim of this placebo-controlled study was to evaluate the effects of pulsed and continuous ultrasound treatments combined with splint therapy on patients with mild and moderate idiopathic carpal tunnel syndrome

Detailed Description

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The study included 36 carpal tunnel syndrome patients who were randomly divided into 3 groups.The first group received 0 W/cm2 placebo ultrasound treatment. second group received 1.0 W/cm2 continuous ultrasound treatment and the third group received 1.0 W/cm2 1:4 pulsed ultrasound treatment 5 days a week for a total of 15 sessions. All patients were also treated with night splints during the treatment. Pretreatment and posttreatment Visual Analogue Scale scores, Symptom Severity Scale scores, Functional Status Scale scores, median nerve motor conduction velocity. and distal latency and sensory conduction velocity of median nerve in the 2nd finger and palm were compared.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ultrasound

ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2

Group Type EXPERIMENTAL

ultrasound

Intervention Type DEVICE

a frequency of 1 megahertz and with an intensity of 1 W/cm2, 5 days a week for a total of 15 sessions

pulsed ultrasound

pulsed ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4

Group Type EXPERIMENTAL

pulsed ultrasound

Intervention Type DEVICE

a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4, 5 days a week for a total of 15 sessions

placebo ultrasound

placebo ultrasound : same ultrasound device as described above seemed to be working but without delivering any output

Group Type PLACEBO_COMPARATOR

placebo ultrasound

Intervention Type DEVICE

same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week for a total of 15 sessions

Interventions

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ultrasound

a frequency of 1 megahertz and with an intensity of 1 W/cm2, 5 days a week for a total of 15 sessions

Intervention Type DEVICE

pulsed ultrasound

a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4, 5 days a week for a total of 15 sessions

Intervention Type DEVICE

placebo ultrasound

same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week for a total of 15 sessions

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Mild or moderate idiopathic carpal tunnel syndrome (without thenar atrophy or spontaneous activity on electrophysiological examination of the abductor pollicis brevis (APB) muscle)

Exclusion Criteria

* Secondary entrapment neuropathies
* Cervical radiculopathy
* Systemic diseases with increased risk of the carpal tunnel syndrome
* Gained surgical relief of the syndrome
* Treated with ultrasound for the syndrome
* A history of steroid injections into the carpal tunnel and of physical therapy within the last 3 months
* Patients with either thenar atrophy or spontaneous activity (fibrillation potentials and positive sharp waves) on electrophysiological examination
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eskisehir Osmangazi University

OTHER

Sponsor Role lead

Responsible Party

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Onur Armağan

Onur Armagan MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Onur ARMAGAN, ass. prof.

Role: STUDY_DIRECTOR

Eskisehir Osmangazi University

References

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Armagan O, Bakilan F, Ozgen M, Mehmetoglu O, Oner S. Effects of placebo-controlled continuous and pulsed ultrasound treatments on carpal tunnel syndrome: a randomized trial. Clinics (Sao Paulo). 2014 Aug;69(8):524-8. doi: 10.6061/clinics/2014(08)04.

Reference Type DERIVED
PMID: 25141110 (View on PubMed)

Other Identifiers

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clinics-2013-0627

Identifier Type: -

Identifier Source: org_study_id

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