Clinical trial NCT04762238: Does the Diacutaneous Fibrolysis Change Ultrasonographic Measurements in Patients With Carpal Tunnel Syndrome?
Official title: Does the Diacutaneous Fibrolysis Change Ultrasonographic Measurements in Patients With Carpal Tunnel Syndrome?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Physical Therapy Modalities
Ultrasonography
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Cross sectional area of the median nerve with ultrasonography
timeFrame: Baseline (Before the treatment)
measure: Cross sectional area of the median nerve with ultrasonography
timeFrame: After treatment application, an average of 2 weeks
Secondary outcomes:
measure: Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)
timeFrame: Baseline (Before the treatment)
measure: Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)
timeFrame: After treatment application, an average of 2 weeks
measure: Thicknesses of transverse carpal ligament with ultrasonography
timeFrame: Baseline (Before the treatment)
measure: Thicknesses of transverse carpal ligament with ultrasonography
timeFrame: After treatment application, an average of 2 weeks
measure: Subjective assessment of clinical change with the Global Rating of Change Scale (GROC Scale)
timeFrame: After treatment application, an average of 2 weeks
Other outcomes:
Locations:
city: Soria
country: Spain
facility: Sandra Jiménez Jiménez-del-Barrio
Study officials:
affiliation: University of Valladolid
name: Sandra Jiménez-del-Barrio, PhD
role: PRINCIPAL_INVESTIGATOR
References: