NCT06399484

Brief Summary

This project is linked to the line of research on carpal tunnel syndrome, of the PhysiUZerapy research group, belonging to the University of Zaragoza. Within this line, the biomechanical and physiological effect of the proposed technique has been investigated, both in healthy subjects, in cadavers and in patients with carpal tunnel syndrome (CTS), resulting in the reading of 2 doctoral theses, the publication of 9 articles in high-impact journals. and the patent for a splint for the treatment of pathology. This project aims to provide information that is still lacking on the immediate effect of these techniques in patients with CTS. For this, there will be three groups of patients from the Lozano Blesa University Clinical Hospital distributed randomly. In two of the groups, sliding and neural tension techniques will be carried out (case group). The remaining group (control group) will be taken as a reference by performing a placebo treatment. Before and after carrying out these techniques, electrophysiological data will be collected to be able to compare them. This comparison is based on highlighting the differences between the data before the techniques and after, as well as between the case group and the control group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 3, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

3 months

First QC Date

April 25, 2024

Last Update Submit

May 1, 2024

Conditions

Outcome Measures

Primary Outcomes (5)

  • Distal motor latency (APB) (ms)

    Before and immediately after the intervention

  • Motor amplitude (APB) (mV)

    Before and immediately after the intervention

  • Median motor velocity (m/s)

    Before and immediately after the intervention

  • Median sensory conduction (digit II) (13 cm) (m/sec)

    Before and immediately after the intervention

  • Sensory amplitude (µV)

    Before and immediately after the intervention

Study Arms (2)

Neural mobilization group

EXPERIMENTAL

Manual mobilizations of the median nerve.

Other: Manual mobilizations of the median nerve

Placebo group

PLACEBO COMPARATOR

wrist movements no producing sliding of the median nerve

Other: Wrist movements

Interventions

Slippage of the median nerve in the wrist: the subject's starting position (P0) will be recumbent supine with the cervical spine in a neutral position, the shoulder girdle in neutral position, 30º of glenohumeral abduction in neutral rotation, 90º of elbow flexion, prone-supination of the neutral forearm, wrist and fingers in neutral position. From this position the movements will be 1) Glenohumeral abduction up to 90º; 2) Glenohumeral external rotation to the frontal plane; 3) Supination of the forearm; 4) Extension of the wrist and fingers; 5) Elbow extension. This position is will combine with an ipsilateral cervical inclination (distal sliding). The proximal slide is carried out bringing the fingers of the hand towards the flexion while performing a contralateral cervical tilt. Median nerve tension: the starting position and movements are the same described above but this time it will be done with contralateral cervical tilt.

Neural mobilization group

Movements of the wrist joint will be performed as a placebo treatment

Placebo group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over 18 years
  • Present carpal tunnel syndrome diagnosed by electroneurogram
  • Have understanding and communication skills
  • Give consent to participate in the study

You may not qualify if:

  • Have received previous surgery on the hand or wrist
  • Present a severe limitation of movement in any of the joints of the affected upper limb
  • Not signing the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clínico Universitario Lozano Blesa

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Study Design

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

Study Record Dates

First Submitted

April 25, 2024

First Posted

May 3, 2024

Study Start

June 15, 2024

Primary Completion

September 15, 2024

Study Completion

December 15, 2024

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations