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NCT Number: NCT04499014

Ultrasound and Phonophoresis in Carpal Tunnel Syndrome

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Ultrasound

Device

5 days a week, a total of 10 sessions

Other names: phonophoresis, placebo ultrasound

Primary outcomes

  1. Visual Analogue Scale

    Time frame: 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.

  2. Boston Symptom Severity Scale

    Time frame: 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

  3. Boston Functional Capacity Scale

    Time frame: 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

  4. grip strength

    Time frame: 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

  5. electroneurophysiological evaluations

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Eskisehir City Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Aug 5, 2020
Registry last updated
Aug 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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