Ultrasound and Phonophoresis in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Evaluation of the Effects of Steroid Phonophoresis and Therapeutic Ultrasound in Carpal Tunnel Syndrome: A Randomized Placebo - Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04499014
• Other study ID #: 1234567
• Status: Completed
• Phase: N/A
• Start date: March 14, 2014
• Est. completion date: January 15, 2016

Study information

• Verified date: January 2016
• Source: Eskisehir City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this placebo-controlled, randomized, prospective study, the efficacy of ultrasonography (US) and steroid phonophoresis (PH) treatments was evaluated in patients with idiopathic carpal tunnel syndrome.

Description:

Twenty-seven patients (46 hands) were admitted in this study. Patients were randomly divided three groups. The first group was ultrasound group, the second group was PH group and the third group was placebo US group. Continuous ultrasound with a frequency of 1 MHz, an intensity of 1.0 W/cm2 was used in the US and the PH groups. PH group received 0,1% dexamethasone. Placebo group received a frequency of 0 MHz, an intensity of 0 W/cm² ultrasound. Treatments were administered for 5 days a week, a total of 10 sessions. All patients also wore night splints during treatment. Visual Analogue Scale (VAS), Boston Symptom Severity Scale, Functional Capacity Scale, grip strength and electroneurophysiological evaluations were compared before the treatment, after the treatment and three months later.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: January 15, 2016
• Est. primary completion date: October 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years 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:

• The patients with medical problems (diabetes mellitus, hypothyroidism, rheumatic diseases, acute trauma, pregnancy etc.)

• cervical radiculopathy

• etiologic factors which predispose to or polyneuropathy

• reinnervation or fibrillation potentials in their abductor pollicis brevis muscles

• physical or medical therapy within 3 months for CTS and steroid injection applied

• experience CTS median nerve trauma and CTS surgery

• serious thenar atrophy and anesthesia

• contraindication in steroid treatment (steroid allergies, hypertension etc.)

• contraindication in ultrasonic therapy (bleeding disorders, acute inflammation of the joints, acute infections, cancer and precancerous lesions, arteriovenous circulatory disorders etc.)

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Device:
• ultrasound
5 days a week, a total of 10 sessions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir City Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale	Change from baseline in pain with Visual Analogue Scale:Patients were asked to express the pain felt by them using 0-10 scales, 0 no pain and 10 the most severe pain faced throughout their life.	three month
Primary	Boston Symptom Severity Scale	Change from baseline in symptom severity with Boston Symptom Severity Scale:Patients were asked to choose an answer among five answers taking 1- 5 points in the questionnaires with 11 statements. Total point was divided into the number of statements and the score was determined and high scores were interpreted as increased symptom severity	three month
Primary	Boston Functional Capacity Scale	Change from baseline in functional status with Boston Functional Capacity Scale:Patients were asked to choose an answer among five answers taking 1- 5 points in the questionnaires with 11 statements. Total point was divided into the number of statements and average score was determined and high scores were interpreted as functionality deformation in the hands	three month
Primary	grip strength	Change from baseline in strength with grip strength:To assess the grip strength, baseline hydraulic hand dynamometer was used. 3 measurements were made for each patient and the average of them was calculated	three month
Primary	electroneurophysiological evaluations	Change from baseline electroneurophysiological measurement:The median nerve motor conduction velocity(m/s) , the median nerve motor distal latency(ms), 2nd finger - palm median nerve sensory distal latency(ms), 2nd finger - palm median nerve sensory conduction velocity(m/s), median sensory nerve conduction velocity(m/s) and median nerve sensory distal latency between the wrist and palm(ms)	three month