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

Primary Purpose

Carpal Tunnel Syndrome, Physical Therapy Modalities, Ultrasonography

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Diacutaneous Fibrolysis
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sandra Jiménez Jiménez-del-Barrio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Actual Diacutaneous Fibrolysis

Sham Diacutaneous Fibrolysis

Arm Description

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 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

Outcomes

Primary Outcome Measures

Cross sectional area of the median nerve with ultrasonography
Cross sectional area of the median nerve with ultrasonography at carpal tunnel level
Cross sectional area of the median nerve with ultrasonography
Cross sectional area of the median nerve with ultrasonography at carpal tunnel level

Secondary Outcome Measures

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

Full Information

First Posted
February 10, 2021
Last Updated
January 14, 2022
Sponsor
Universidad de Zaragoza
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1. Study Identification

Unique Protocol Identification Number
NCT04762238
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 10, 2021 (Actual)
Primary Completion Date
May 20, 2021 (Actual)
Study Completion Date
July 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Physical Therapy Modalities, Ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Actual Diacutaneous Fibrolysis
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham Diacutaneous Fibrolysis
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Diacutaneous Fibrolysis
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cross sectional area of the median nerve with ultrasonography
Description
Cross sectional area of the median nerve with ultrasonography at carpal tunnel level
Time Frame
Baseline (Before the treatment)
Title
Cross sectional area of the median nerve with ultrasonography
Description
Cross sectional area of the median nerve with ultrasonography at carpal tunnel level
Time Frame
After treatment application, an average of 2 weeks
Secondary Outcome Measure Information:
Title
Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)
Description
Intensity of numbness with Visual Analogue Scale (1-10cm)
Time Frame
Baseline (Before the treatment)
Title
Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)
Description
Intensity of numbness with Visual Analogue Scale (1-10cm)
Time Frame
After treatment application, an average of 2 weeks
Title
Thicknesses of transverse carpal ligament with ultrasonography
Description
the thicknesses of transverse carpal ligament on the cross-section at the level of hamate bone with ultrasonography at carpal tunnel level
Time Frame
Baseline (Before the treatment)
Title
Thicknesses of transverse carpal ligament with ultrasonography
Description
the thicknesses of transverse carpal ligament on the cross-section at the level of hamate bone with ultrasonography at carpal tunnel level
Time Frame
After treatment application, an average of 2 weeks
Title
Subjective assessment of clinical change with the Global Rating of Change Scale (GROC Scale)
Description
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").
Time Frame
After treatment application, an average of 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Jiménez-del-Barrio, PhD
Organizational Affiliation
University of Valladolid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sandra Jiménez Jiménez-del-Barrio
City
Soria
ZIP/Postal Code
42004
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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

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