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Completed

NCT Number: NCT04762238

Does the Diacutaneous Fibrolysis Change Ultrasonographic Measurements in Patients With Carpal Tunnel Syndrome?

The carpal tunnel syndrome (CTS) is a common entrapment neuropathy caused by compression of the median nerve at the wrist.Clinically electroneuphysiological assessment is not accessible to all clinicians. In this way ultrasounds (US) is a more accessible and economical tool and many studies have reported that US has high sensitivity and specificity in the diagnosis of CTS.Diacutaneous Fibrolysis (DF) is a physiotherapeutic technique derived from Cyriax deep friction massage principles.DF technique could assist in improving changes in the connective tissues adjacent to the median nerve, especially the thickness of TCL and this could be reflected in a decreasing of TCL. Moreover, the neurophysiological and mechanical effect described by this technique may improve the nerve compression decreasing the CSA of the median nerve.

The purpose of this study is to quantify changes in the cross-sectional area of the median nerve in the carpal tunnel and the thickness of transversal carpal ligament measured by US and the changes in the intensity of the numbness and the subjective assessment of clinical change after DF treatment in forearm, wrist and hand area compared to placebo.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sandra Jiménez Jiménez-del-Barrio

Soria, 42004, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosed medically with neurophysiological test of carpal tunnel syndrome (low and moderate intensity)

Exclusion criteria

  • Severe carpal tunnel syndrome
  • Previous surgery on the hand
  • hormonal factors: diabetes, thyroids pathologies, pregnant
  • Cervical disfunctions
  • Ulcerations or skins disorders

Treatment and study plan

Diacutaneous Fibrolysis

Other

Diacutaneous Fibrolysis is a non invasive physiotherapeutic technique applied by means of a set of metallic hooks ending a spatula with bevelled edges that help to treat the muscles and conjunctive tissues and trying to improve mobility between mobility between muscle planes.

Primary outcomes

  1. Cross sectional area of the median nerve with ultrasonography

    Time frame: Baseline (Before the treatment)

    Cross sectional area of the median nerve with ultrasonography at carpal tunnel level

  2. Cross sectional area of the median nerve with ultrasonography

    Time frame: After treatment application, an average of 2 weeks

    Cross sectional area of the median nerve with ultrasonography at carpal tunnel level

Secondary outcomes

  1. Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)

    Time frame: Baseline (Before the treatment)

    Intensity of numbness with Visual Analogue Scale (1-10cm)

  2. Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)

    Time frame: After treatment application, an average of 2 weeks

    Intensity of numbness with Visual Analogue Scale (1-10cm)

  3. Thicknesses of transverse carpal ligament with ultrasonography

    Time frame: Baseline (Before the treatment)

    the thicknesses of transverse carpal ligament on the cross-section at the level of hamate bone with ultrasonography at carpal tunnel level

  4. Thicknesses of transverse carpal ligament with ultrasonography

    Time frame: After treatment application, an average of 2 weeks

    the thicknesses of transverse carpal ligament on the cross-section at the level of hamate bone with ultrasonography at carpal tunnel level

  5. Subjective assessment of clinical change with the Global Rating of Change Scale (GROC Scale)

    Time frame: After treatment application, an average of 2 weeks

    Subjective assessment of clinical change with Global Rating of Change Scale (GROC scale) a scale ranging from -7 ("a very great deal worse") to 0 ("about the same") to +7 ("a very great deal better").

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 21, 2021
Registry last updated
Jan 18, 2022

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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