Neural Exercises vs Surgery in Patients With Carpal Tunnel Syndrome

NCT ID: NCT04058041

Last Updated: 2019-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-12

Study Completion Date

2020-09-20

Brief Summary

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neural exercise in patients with carpal tunnel syndrome

Detailed Description

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OBJECTIVE: The aim objective is to compare the neurophysiological effects of the surgery versus neural mobilization exercises added to surgery versus only neural mobilization exercises on temporal summation and noxious inhibitory pain system and their relationship with the improve of symptoms, with pain and disability in patients with Carpal tunnel syndrome.

STUDY DESIGN: Randomized parallel-group trial. BACKGROUND: Carpal tunnel syndrome (CTS) such as a neuropathic pain condition with altered pain modulation and wind-up, but there is a clack of knowledge if some therapies could have a positive effect.

METHODS: In the Humans study, 54 patients with CTS will be randomly allocated to either a surgery group (n=18) or Surgery with neural exercises group (n=18) or neural exercise group (n=18), the groups with neural exercise will received 10 sessions. The primary outcome will be conditioned pain modulation, temporal summation, pain intensity,. Secondary outcomes will be hand disability assessed with the Boston Carpal Tunnel Questionnaire, pinch-tip grip force, and the symptom severity subscale of the Boston Carpal Tunnel Questionnaire, neuropathic pain questionnaire (DN4), psychological questionnaires (anxiety, catastrophizing, kinesiophobia depression and fear avoid questionnaires), and pressure pain threshold. Patients will be assessed baseline and post-treatment, 1, 3 and 6 months after the last treatment by an assessor unaware of group assignment Patients were assessed at. Analysis was by intention to treat, with mixed analyses of covariance adjusted for baseline scores.

Conditions

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Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Neural mobilization

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

Group Type EXPERIMENTAL

Surgery

Intervention Type PROCEDURE

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

Surgery and neural mobilization

Intervention Type PROCEDURE

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

Surgery

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.

Group Type ACTIVE_COMPARATOR

Neural Mobilization

Intervention Type PROCEDURE

neural exercise Will be performed in the patients

Surgery and neural mobilization

Intervention Type PROCEDURE

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

Surgery and Neural mobilization

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.

Group Type ACTIVE_COMPARATOR

Neural Mobilization

Intervention Type PROCEDURE

neural exercise Will be performed in the patients

Surgery

Intervention Type PROCEDURE

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

Interventions

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Neural Mobilization

neural exercise Will be performed in the patients

Intervention Type PROCEDURE

Surgery

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

Intervention Type PROCEDURE

Surgery and neural mobilization

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

Previous surgery Wrist fractures Rheumatoid Arthritis or Fibromyalgia Systemic disease Pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Rey Juan Carlos

OTHER

Sponsor Role lead

Responsible Party

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Josue Fernandez Carnero

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad Rey Juan Carlos

Alcorcón, Madrid, Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Josué Fernández, PhD

Role: CONTACT

34914888949

Luis Matesanz

Role: CONTACT

675042482

Facility Contacts

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Josué Fernández, PhD

Role: primary

34914888949

Other Identifiers

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CPMP/ICH/135/95

Identifier Type: -

Identifier Source: org_study_id

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