NCT02054247

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2011

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 4, 2014

Completed
9.8 years until next milestone

Results Posted

Study results publicly available

November 7, 2023

Completed
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

1.7 years

First QC Date

January 27, 2014

Results QC Date

August 5, 2014

Last Update Submit

November 6, 2023

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal tunnel syndrome,ultrasound,pulsed ultrasound

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Symptom Severity With Symptom Severity Scale

    Post treatment comparison of Symptom Severity Scale between three groups minimum score is 11, maximum score is 55. The clinic of patient worses when the score increases.

    three weeks

Secondary Outcomes (3)

  • Change From Baseline in Pain With Visual Analogue Scale

    Three weeks

  • Change From Baseline in Functional Status With Functional Status Scale

    Three weeks

  • Changes From Baseline Nervus Medianus Motor Conduction Velocity

    Three weeks

Study Arms (3)

ultrasound

EXPERIMENTAL

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

Device: ultrasound

pulsed ultrasound

EXPERIMENTAL

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

placebo ultrasound

PLACEBO COMPARATOR

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

Device: placebo ultrasound

Interventions

ultrasoundDEVICE

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

ultrasound
pulsed ultrasoundDEVICE

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

pulsed ultrasound
placebo ultrasoundDEVICE

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

placebo ultrasound

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25141110DERIVED

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Results Point of Contact

Title
Dr. Onur Armagan
Organization
Eskisehir Osmangazi University
dronurarmagan@hotmail.com
00902222392979

Study Officials

  • Onur ARMAGAN, ass. prof.

    Eskisehir Osmangazi University

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Onur Armagan MD

Study Record Dates

First Submitted

January 27, 2014

First Posted

February 4, 2014

Study Start

October 1, 2011

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

November 7, 2023

Results First Posted

November 7, 2023

Record last verified: 2023-11