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NCT Number: NCT05863546

Effect of Different Doses of US in the Treatment of CTS

The purpose of this study was to investigate the effective dose of therapeutic ultrasound in the treatment of carpal tunnel syndrome on pain level, functional ability, motor and sensory nerve conduction parameters and pinch strength.

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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

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ismailia Medical Complex

Ismailia, Egypt

About this study

Carpal tunnel syndrome (CTS) is among the most common peripheral neuropathies causing the median nerve compression as it crosses the carpal tunnel, with an estimated prevalence of about 4 - 5% of the general population. Patients suffering from this syndrome mainly complain about paresthesia (pain, numbness, and tingling) in the innervation area of the median nerve in the hand which could be accompanied by weakness and atrophy of thenar muscles.

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper limb and a significant contributor to hand functional impairment and disability that could be treated through numerous approaches. Effective treatment options include conservative and surgical interventions.

Carpal Tunnel Syndrome (CTS) remains a puzzling and disabling condition present in 3.8% of the general population. CTS is the most well-known and frequent form of median nerve entrapment, and accounts for 90% of all entrapment neuropathies.

Physiotherapy modalities are used to help patients with CTS in many cases. They can both help to improve CTS symptoms as well as resolve the cause of the syndrome. Physiotherapy intervention may include special exercises, mobilizations, ergonomic interventions and advice for as well as electrotherapy modalities, aiming for the treatment and improvement of symptoms.

Ultrasound waves have anti-inflammatory properties, stimulating nerve regeneration and improving nerve conductivity.

The most common uses for US are to decrease soft tissue inflammation, increase tissue extensibility, enhance scar tissue remodeling, increase soft tissue healing, decrease pain, and decrease soft tissue swelling .

The issue of selecting the nature of the ultrasonic wave has not been finally resolved. A continuous wave is more often used to reduce pain and increase the elasticity of the tissue, while a pulsed wave mode is applied to reduce swelling and to eliminate inflammation. The rate of absorption, and thus the thermal effect, is based on the tissue type encountered, the frequency of the ultrasound beam, and the intensity (W/cm2) of the ultrasonic output.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject's age range was 25-55 years .
  • Mild to moderate CTS, that is confirmed by neurologist or orthopedist based on results of physical examination and electrophysiological criteria; i. Mild CTS is characterized by sensory fibers involvement (sensory peak latency > 3.6 milliseconds) with no motor fiber involvement (motor distal latency < 4.1 milliseconds), provided that sensory nerve action potential (SNAP) is not absent.

ii. Moderate CTS is characterized by involvement of both sensory and motor fibers, provided that neither of these two waves is absent .

  • Pain intensity more than 5 in visual analogue scale (VAS).

Exclusion criteria

  • History of any trauma on the hands, neck, and shoulders within 3 months of the study onset
  • Cervical radiculopathy, peripheral polyneuropathy, or other neurological conditions.
  • Patients suffering from severe CTS according to electrophysiological criteria

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Treatment and study plan

traditional treatment

Other

The patients received traditional physical therapy treatment for carpal tunnel syndrome, in the form of hot packs, tendon and nerve glide exercises, and wrist splint for 4 weeks.

Therapeutic Ultrasound

Device

US treatment sessions were performed for 6 min per session, once a day, three days a week, for a total of 4 weeks.

Primary outcomes

  1. symptoms severity and functional status

    Time frame: Four weeks

    Symptoms severity and functional status were measured by Boston carpal tunnel syndrome questionnaire. The patients rated their ability to perform the activity on a scale that ranged from 1 (no difficulty with the activity) to 5 (cannot perform the activity at all).

  2. median nerve motor distal latency

    Time frame: Four weeks

    Electrodiagnostic tests were used to measure median nerve motor distal latency in milliseconds.

  3. median nerve motor amplitude

    Time frame: Four weeks

    Electrodiagnostic tests were used to measure motor amplitude in millivolt.

  4. median nerve sensory distal latency

    Time frame: Four weeks

    Electrodiagnostic tests were used to measure median nerve sensory distal latency in milliseconds.

  5. median nerve sensory amplitude

    Time frame: Four weeks

    Electrodiagnostic tests were used to measure sensory amplitude in millivolt

  6. Pain intensity

    Time frame: Four weeks

    Pain intensity was measured by visual analogue scale. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm).

  7. Pinch strength

    Time frame: Four weeks

    Pinch dynamometer was used to measure pinch strength

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Effect of Different Doses of Therapeutic Ultrasound in the Treatment of Carpal Tunnel Syndrome

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 18, 2023
Registry last updated
Mar 14, 2025

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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