Ultrasound and Phonophoresis in Carpal Tunnel Syndrome

NCT04499014 | Completed

• 1 other identifier: 1234567
• Study Type: interventional
• Target: 27
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Carpal Tunnel Syndrome

Keywords

carpal tunnel syndrome; steroid phonophoresis; ultrasound

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

ultrasound

EXPERIMENTAL

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

Device: ultrasound

phonophoresis

EXPERIMENTAL

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

Device: ultrasound

placebo ultrasound

PLACEBO COMPARATOR

same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week, a total of 10 sessions

Device: ultrasound

Interventions

ultrasound DEVICE

5 days a week, a total of 10 sessions

Also known as: phonophoresis, placebo ultrasound

phonophoresis; placebo ultrasound; ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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:

• 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.)

Sponsors & Collaborators

• Eskisehir City Hospital: lead

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Ultrasonography; Phonophoresis

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Burcu Ortanca

  Eskişehir City Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 28, 2020
• First Posted: August 5, 2020
• Study Start: March 14, 2014
• Primary Completion: October 1, 2015
• Study Completion: January 15, 2016
• Last Updated: August 5, 2020

Record last verified: 2016-01