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

NCT04762238 | Completed DMC

• 1 other identifier: University of Zaragoza
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)

  Baseline (Before the treatment)

• Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)

  After treatment application, an average of 2 weeks

• Thicknesses of transverse carpal ligament with ultrasonography

  Baseline (Before the treatment)

• Thicknesses of transverse carpal ligament with ultrasonography

  After treatment application, an average of 2 weeks

• Subjective assessment of clinical change with the Global Rating of Change Scale (GROC Scale)

  After treatment application, an average of 2 weeks

Study Arms (2)

Actual Diacutaneous Fibrolysis

EXPERIMENTAL

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

Sham Diacutaneous Fibrolysis

SHAM COMPARATOR

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

Interventions

Diacutaneous Fibrolysis 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.

Actual Diacutaneous Fibrolysis; Sham Diacutaneous Fibrolysis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Diagnosed medically with neurophysiological test of carpal tunnel syndrome (low and moderate intensity)

You may not qualify if:

• Severe carpal tunnel syndrome
• Previous surgery on the hand
• hormonal factors: diabetes, thyroids pathologies, pregnant
• Cervical disfunctions
• Ulcerations or skins disorders

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Sandra Jiménez Jiménez-del-Barrio

Soria, 42004, Spain

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• Sandra Jiménez-del-Barrio, PhD

  University of Valladolid

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Physiotherapist

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 21, 2021
• Study Start: February 10, 2021
• Primary Completion: May 20, 2021
• Study Completion: July 10, 2021
• Last Updated: January 18, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)