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Continuous And Pulsed Ultrasound Treatments On Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT02054247
Recruitment Status : Completed
First Posted : February 4, 2014
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Onur Armağan, Eskisehir Osmangazi University

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Device: ultrasound Device: pulsed ultrasound Device: placebo ultrasound Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Placebo-Controlled Continuous And Pulsed Ultrasound Treatments on Carpal Tunnel Syndrome : A Randomised Trial
Study Start Date : October 2011
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013


Arm Intervention/treatment
Experimental: ultrasound
ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2
Device: ultrasound
a frequency of 1 megahertz and with an intensity of 1 W/cm2, 5 days a week for a total of 15 sessions

Experimental: 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
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

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




Primary Outcome Measures :
  1. Change from baseline in symptom severity with Symptom Severity Scale [ Time Frame: three weeks ]

Secondary Outcome Measures :
  1. Change from baseline in pain with Visual Analogue Scale [ Time Frame: Three weeks ]
  2. Change from baseline in functional status with Functional Status Scale [ Time Frame: Three weeks ]
  3. Chances from baseline median nerve motor and sensory conduction velocity and distal latencies [ Time Frame: Three weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02054247


Sponsors and Collaborators
Eskisehir Osmangazi University
Investigators
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Study Director: Onur ARMAGAN, ass. prof. Eskisehir Osmangazi University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Onur Armağan, Onur Armagan MD, Eskisehir Osmangazi University
ClinicalTrials.gov Identifier: NCT02054247    
Other Study ID Numbers: clinics-2013-0627
First Posted: February 4, 2014    Key Record Dates
Last Update Posted: February 4, 2014
Last Verified: February 2014
Keywords provided by Onur Armağan, Eskisehir Osmangazi University:
Carpal tunnel syndrome,ultrasound,pulsed ultrasound
Additional relevant MeSH terms:
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Carpal Tunnel Syndrome
Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries