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Continuous And Pulsed Ultrasound Treatments On Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasound
pulsed ultrasound
placebo ultrasound
Sponsored by
Eskisehir Osmangazi University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring Carpal tunnel syndrome,ultrasound,pulsed ultrasound

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    ultrasound

    pulsed ultrasound

    placebo ultrasound

    Arm Description

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

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

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

    Outcomes

    Primary Outcome Measures

    Change from baseline in symptom severity with Symptom Severity Scale

    Secondary Outcome Measures

    Change from baseline in pain with Visual Analogue Scale
    Change from baseline in functional status with Functional Status Scale
    Chances from baseline median nerve motor and sensory conduction velocity and distal latencies

    Full Information

    First Posted
    January 27, 2014
    Last Updated
    February 3, 2014
    Sponsor
    Eskisehir Osmangazi University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02054247
    Brief Title
    Continuous And Pulsed Ultrasound Treatments On Carpal Tunnel Syndrome
    Official Title
    The Placebo-Controlled Continuous And Pulsed Ultrasound Treatments on Carpal Tunnel Syndrome : A Randomised Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    October 2011 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Eskisehir Osmangazi University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carpal Tunnel Syndrome
    Keywords
    Carpal tunnel syndrome,ultrasound,pulsed ultrasound

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Factorial Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    46 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ultrasound
    Arm Type
    Experimental
    Arm Description
    ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2
    Arm Title
    pulsed ultrasound
    Arm Type
    Experimental
    Arm Description
    pulsed ultrasound : a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4
    Arm Title
    placebo ultrasound
    Arm Type
    Placebo Comparator
    Arm Description
    placebo ultrasound : same ultrasound device as described above seemed to be working but without delivering any output
    Intervention Type
    Device
    Intervention Name(s)
    ultrasound
    Intervention Description
    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
    Intervention Name(s)
    pulsed ultrasound
    Intervention Description
    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
    Intervention Name(s)
    placebo ultrasound
    Intervention Description
    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 Measure Information:
    Title
    Change from baseline in symptom severity with Symptom Severity Scale
    Time Frame
    three weeks
    Secondary Outcome Measure Information:
    Title
    Change from baseline in pain with Visual Analogue Scale
    Time Frame
    Three weeks
    Title
    Change from baseline in functional status with Functional Status Scale
    Time Frame
    Three weeks
    Title
    Chances from baseline median nerve motor and sensory conduction velocity and distal latencies
    Time Frame
    Three weeks

    10. Eligibility

    Sex
    Female
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Onur ARMAGAN, ass. prof.
    Organizational Affiliation
    Eskisehir Osmangazi University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    25141110
    Citation
    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.
    Results Reference
    derived

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    Continuous And Pulsed Ultrasound Treatments On Carpal Tunnel Syndrome

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