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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04762238
Enrollment
60
Registered
2021-02-21
Start date
2021-02-10
Completion date
2021-07-10
Last updated
2022-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome, Physical Therapy Modalities, Ultrasonography

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.

Interventions

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.

Sponsors

Universidad de Zaragoza
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cross sectional area of the median nerve with ultrasonographyBaseline (Before the treatment)Cross sectional area of the median nerve with ultrasonography at carpal tunnel level

Secondary

MeasureTime frameDescription
Intensity of numbness with the Visual Analogue Scale (VAS 1-10cm)Baseline (Before the treatment)Intensity of numbness with Visual Analogue Scale (1-10cm)
Thicknesses of transverse carpal ligament with ultrasonographyBaseline (Before the treatment)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 weeksSubjective 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).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026