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

NCT ID: NCT04762238

Last Updated: 2022-01-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-10
• Study Completion Date: 2021-07-10

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.

Conditions

Carpal Tunnel Syndrome; Physical Therapy Modalities; Ultrasonography

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Diacutaneous Fibrolysis

Intervention Type: 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.

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

Group Type: SHAM_COMPARATOR

Diacutaneous Fibrolysis

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Zaragoza

OTHER

Sponsor Role: lead

Responsible Party

Sandra Jiménez

PhD Physiotherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sandra Jiménez-del-Barrio, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valladolid

Locations

Sandra Jiménez Jiménez-del-Barrio

Soria, , Spain

Countries

Spain

Other Identifiers

University of Zaragoza

Identifier Type: -

Identifier Source: org_study_id