Ultrasound and Phonophoresis in Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Device: ultrasound

• Registration Number: NCT04499014
• Lead Sponsor: Eskisehir City Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-03-14
• Primary Completion: 2015-10-01
• Status Verified: 2016-01
• Study Completion: 2016-01-15
• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-07-30
• Last Update Submitted: 2020-07-30
• Study First Posted: 2020-08-05
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
placebo ultrasound	ultrasound	same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week, a total of 10 sessions
ultrasound	ultrasound	ultrasound : a frequency of 1 MHz and an intensity of 1 W/cm2, 5 days a week, a total of 10 sessions
phonophoresis	ultrasound	an intensity of 1 W/cm2 and a frequency of 1 MHz and phonophoresis with 0.1% dexamethasone pomade,5 days a week, a total of 10 sessions

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale	three month	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.
Boston Symptom Severity Scale	three month	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
Boston Functional Capacity Scale	three month	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
grip strength	three month	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
electroneurophysiological evaluations	three month	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)