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.

Study Overview

• Status: Completed
• Conditions: Carpal Tunnel Syndrome; Ultrasonography; Physical Therapy Modalities
• Intervention / Treatment: Other: Diacutaneous Fibrolysis

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Soria, Spain, 42004
    • Sandra Jiménez Jiménez-del-Barrio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Actual 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.	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.
Sham Comparator: Sham 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)	Intensity of numbness with Visual Analogue Scale (1-10cm)	Baseline (Before the treatment)
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
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)
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
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

Collaborators and Investigators

• Sponsor: Universidad de Zaragoza
• Investigators: Principal Investigator: Sandra Jiménez-del-Barrio, PhD, University of Valladolid

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2021
• Primary Completion (Actual): May 20, 2021
• Study Completion (Actual): July 10, 2021

Study Registration Dates

• First Submitted: February 10, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 21, 2021

Study Record Updates

• Last Update Posted (Actual): January 18, 2022
• Last Update Submitted That Met QC Criteria: January 14, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Wounds and Injuries; Disease; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Syndrome; Carpal Tunnel Syndrome
• Other Study ID Numbers: University of Zaragoza

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No