NCT04058041

Brief Summary

neural exercise in patients with carpal tunnel syndrome

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
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

February 13, 2018

Completed
27 days until next milestone

Study Start

First participant enrolled

March 12, 2018

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

August 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2020

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

1.9 years

First QC Date

February 13, 2018

Last Update Submit

August 14, 2019

Conditions

Keywords

Neural mobilizationSurgeryPain modulation

Outcome Measures

Primary Outcomes (1)

  • Physiological parameter

    Conditioned pain modulation: Diffuse noxious inhibitory control system will be measure with tourniquet test

    Change from Baseline Conditioned pain modulation at 6 months

Secondary Outcomes (13)

  • Neuropathic pain

    Baseline and 6 months

  • Pain intensity

    Baseline and 6 months

  • Pain expansion

    Change from baseline and 6 months

  • Pressure pain threshold

    Baseline and 6 months

  • Psychological factors_Anxiety

    Baseline and 6 months

  • +8 more secondary outcomes

Study Arms (3)

Neural mobilization

EXPERIMENTAL

passive mobilization of the median nerve by the therapist following by an active movement of the fingers of the pathology hand

Procedure: SurgeryProcedure: Surgery and neural mobilization

Surgery

ACTIVE COMPARATOR

the surgeon will release the median nerve in the tunnel carpal. After that the therapist will teach home exercises (no neural exercises) to the patients.

Procedure: Neural MobilizationProcedure: Surgery and neural mobilization

Surgery and Neural mobilization

ACTIVE COMPARATOR

the surgeon will release the median nerve in the tunnel carpal. After that the therapist will perform mobilizations of the median nerve just like the experimental group.

Procedure: Neural MobilizationProcedure: Surgery

Interventions

neural exercise Will be performed in the patients

SurgerySurgery and Neural mobilization
SurgeryPROCEDURE

open or endoscopic surgery will be permed in the patients with tunnel carpal syndrome

Neural mobilizationSurgery and Neural mobilization

following the surgery patients will be treat with neural mobilization exercises.

Neural mobilizationSurgery

Eligibility Criteria

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

You may qualify if:

  • Tinel and Phalen positive 4/10 in VAS Scale Increase symptoms at night 12 months of symptomatology Sensorial and motor dysfunction in the conduction of the median nerve

You may not qualify if:

  • Previous surgery Wrist fractures Rheumatoid Arthritis or Fibromyalgia Systemic disease Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

RECRUITING

MeSH Terms

Conditions

Neuralgia

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Josué Fernández, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2018

First Posted

August 15, 2019

Study Start

March 12, 2018

Primary Completion

February 12, 2020

Study Completion

September 20, 2020

Last Updated

August 15, 2019

Record last verified: 2019-08

Locations