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

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome; Physical Therapy Modalities; Ultrasonography
• Interventions: Other: Diacutaneous Fibrolysis

• Registration Number: NCT04762238
• Lead Sponsor: Universidad de Zaragoza

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-10
• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-21
• Primary Completion: 2021-05-20
• Study Completion: 2021-07-10
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-14
• Last Update Posted: 2022-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Actual Diacutaneous Fibrolysis	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.
Sham Diacutaneous Fibrolysis	Diacutaneous Fibrolysis	Sham Diacutaneous Fibrolysis is applied at a superficial level. A pinch of skin was held with the thumb of the palpatory hand and the tip of the spatula but without effect in the muscle because no penetrate in deep tissue

Primary Outcome Measures

Name	Time	Method
Cross sectional area of the median nerve with ultrasonography	After treatment application, an average of 2 weeks	Cross sectional area of the median nerve with ultrasonography at carpal tunnel level

Secondary Outcome Measures

Name	Time	Method
Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)	After treatment application, an average of 2 weeks	Intensity of numbness with Visual Analogue Scale (1-10cm)
Thicknesses of transverse carpal ligament with ultrasonography	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
Subjective assessment of clinical change with the Global Rating of Change Scale (GROC Scale)	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").

Trial Locations

Locations (1)

Sandra Jiménez Jiménez-del-Barrio; 🇪🇸 Soria, Spain