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

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04762238
• Other study ID #: University of Zaragoza
• Status: Completed
• Phase: N/A
• Start date: February 10, 2021
• Est. completion date: July 10, 2021

Study information

• Verified date: January 2022
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 10, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Physical Therapy Modalities
• Syndrome
• Ultrasonography

Intervention

Other:
• Diacutaneous Fibrolysis
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.

Locations

Country	Name	City	State
Spain	Sandra Jiménez Jiménez-del-Barrio	Soria

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Zaragoza

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cross sectional area of the median nerve with ultrasonography	Cross sectional area of the median nerve with ultrasonography at carpal tunnel level	Baseline (Before the treatment)
Primary	Cross sectional area of the median nerve with ultrasonography	Cross sectional area of the median nerve with ultrasonography at carpal tunnel level	After treatment application, an average of 2 weeks
Secondary	Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)	Intensity of numbness with Visual Analogue Scale (1-10cm)	Baseline (Before the treatment)
Secondary	Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)	Intensity of numbness with Visual Analogue Scale (1-10cm)	After treatment application, an average of 2 weeks
Secondary	Thicknesses of transverse carpal ligament with ultrasonography	the thicknesses of transverse carpal ligament on the cross-section at the level of hamate bone with ultrasonography at carpal tunnel level	Baseline (Before the treatment)
Secondary	Thicknesses of transverse carpal ligament with ultrasonography	the thicknesses of transverse carpal ligament on the cross-section at the level of hamate bone with ultrasonography at carpal tunnel level	After treatment application, an average of 2 weeks
Secondary	Subjective assessment of clinical change with the Global Rating of Change Scale (GROC Scale)	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").	After treatment application, an average of 2 weeks