Continuous And Pulsed Ultrasound Treatments On Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

The Placebo-Controlled Continuous And Pulsed Ultrasound Treatments on Carpal Tunnel Syndrome : A Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02054247
• Other study ID #: clinics-2013-0627
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: June 2013

Study information

• Verified date: November 2023
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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
• 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 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Pain With Visual Analogue Scale	Post treatment comparison of Visual Analogue Scale between three groups min score is 0, maximum score is 10. The clinic of patient worses when the score increases.	Three weeks
Secondary	Change From Baseline in Functional Status With Functional Status Scale	Post treatment comparison of Functional Status Scale between three groups min score is 8, maximum score is 40. The clinic of patient worses when the score increases.	Three weeks
Secondary	Changes From Baseline Nervus Medianus Motor Conduction Velocity	Post treatment comparison of Median motor nerve conduction velocity between three groups	Three weeks