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NCT Number: NCT02054247

Continuous And Pulsed Ultrasound Treatments On Carpal Tunnel Syndrome

The aim of this placebo-controlled study was to evaluate the effects of pulsed and continuous ultrasound treatments combined with splint therapy on patients with mild and moderate 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

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

The study included 36 carpal tunnel syndrome patients who were randomly divided into 3 groups.The first group received 0 W/cm2 placebo ultrasound treatment. second group received 1.0 W/cm2 continuous ultrasound treatment and the third group received 1.0 W/cm2 1:4 pulsed ultrasound treatment 5 days a week for a total of 15 sessions. All patients were also treated with night splints during the treatment. Pretreatment and posttreatment Visual Analogue Scale scores, Symptom Severity Scale scores, Functional Status Scale scores, median nerve motor conduction velocity. and distal latency and sensory conduction velocity of median nerve in the 2nd finger and palm were compared.

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

  • Secondary entrapment neuropathies
  • Cervical radiculopathy
  • Systemic diseases with increased risk of the carpal tunnel syndrome
  • Gained surgical relief of the syndrome
  • Treated with ultrasound for the syndrome
  • A history of steroid injections into the carpal tunnel and of physical therapy within the last 3 months
  • Patients with either thenar atrophy or spontaneous activity (fibrillation potentials and positive sharp waves) on electrophysiological examination

Treatment and study plan

Ultrasound

Device

a frequency of 1 megahertz and with an intensity of 1 W/cm2, 5 days a week for a total of 15 sessions

pulsed ultrasound

Device

a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4, 5 days a week for a total of 15 sessions

Placebo Ultrasound

Device

same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week for a total of 15 sessions

Primary outcomes

  1. Change From Baseline in Symptom Severity With Symptom Severity Scale

    Time frame: three weeks

    Post treatment comparison of Symptom Severity Scale between three groups minimum score is 11, maximum score is 55. The clinic of patient worses when the score increases.

Secondary outcomes

  1. Change From Baseline in Pain With Visual Analogue Scale

    Time frame: Three weeks

    Post treatment comparison of Visual Analogue Scale between three groups min score is 0, maximum score is 10. The clinic of patient worses when the score increases.

  2. Change From Baseline in Functional Status With Functional Status Scale

    Time frame: Three weeks

    Post treatment comparison of Functional Status Scale between three groups min score is 8, maximum score is 40. The clinic of patient worses when the score increases.

  3. Changes From Baseline Nervus Medianus Motor Conduction Velocity

    Time frame: Three weeks

    Post treatment comparison of Median motor nerve conduction velocity between three groups

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

The Placebo-Controlled Continuous And Pulsed Ultrasound Treatments on Carpal Tunnel Syndrome : A Randomised Trial

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 4, 2014
Registry last updated
Nov 7, 2023

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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