Ultrasound and Phonophoresis in Carpal Tunnel Syndrome

NCT ID: NCT04499014

Last Updated: 2020-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-14
• Study Completion Date: 2016-01-15

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.

Conditions

Carpal Tunnel Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

ultrasound

ultrasound : a frequency of 1 MHz and an intensity of 1 W/cm2, 5 days a week, a total of 10 sessions

Group Type: EXPERIMENTAL

ultrasound

Intervention Type: DEVICE

5 days a week, a total of 10 sessions

phonophoresis

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

Group Type: EXPERIMENTAL

ultrasound

Intervention Type: DEVICE

5 days a week, a total of 10 sessions

placebo 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

Group Type: PLACEBO_COMPARATOR

ultrasound

Intervention Type: DEVICE

5 days a week, a total of 10 sessions

Interventions

ultrasound

5 days a week, a total of 10 sessions

Intervention Type: DEVICE

Other Intervention Names

phonophoresis; placebo ultrasound

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

• 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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eskisehir City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Fulya Bakılan

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Burcu Ortanca

Role: PRINCIPAL_INVESTIGATOR

Eskişehir City Hospital

Other Identifiers

1234567

Identifier Type: -

Identifier Source: org_study_id