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Neural Exercises vs Surgery in Patients With Carpal Tunnel Syndrome

Primary Purpose

Neuropathic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Neural Mobilization
Surgery
Surgery and neural mobilization
Sponsored by
Universidad Rey Juan Carlos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Neural mobilization, Surgery, Pain modulation

Eligibility Criteria

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

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

Sites / Locations

  • Universidad Rey Juan CarlosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Neural mobilization

Surgery

Surgery and Neural mobilization

Arm Description

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

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Neuropathic pain
Neuropathic pain Questionnaire DN4
Pain intensity
Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
Pain expansion
Body pain maps
Pressure pain threshold
Three consecutive trials of pressure pain threshold on the active trigger point at a rate of 1 kg/sec at intervals of 30 seconds were conducted.
Psychological factors_Anxiety
State Trait Anxiety Inventory (STAI-T)
Psychological factors_Depression
Beck Depression Inventory (BDI-II)
Psychological factors_Kinesiophobia
Tampa Scale for Kinesiophobia.. The score goes from 11 to 44. A higher value indicates a worse outcome.
Psychological factors_catastrophizing
Pain Catastrophizing Scale. The scores goes from 0 to 52. A higher value indicates a worse outcome.
Psychological factors_Fear avoidance
Fear Avoidance Belief Questionnaire (FABQ)
Disability_DASH
Disabilities of Arm, Shoulder and Hand (DASH)
Disability_BOSTON
Boston Carpal Tunnel Questionnaire
Strength_grip
grip strength without pain
Strength_pinch
pinch strength

Full Information

First Posted
February 13, 2018
Last Updated
August 14, 2019
Sponsor
Universidad Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT04058041
Brief Title
Neural Exercises vs Surgery in Patients With Carpal Tunnel Syndrome
Official Title
Effectiveness of Neural Mobilizations Exercises Versus Surgery in Patients With Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 12, 2018 (Actual)
Primary Completion Date
February 12, 2020 (Anticipated)
Study Completion Date
September 20, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
neural exercise in patients with carpal tunnel syndrome
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain
Keywords
Neural mobilization, Surgery, Pain modulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neural mobilization
Arm Type
Experimental
Arm Description
passive mobilization of the median nerve by the therapist following by an active movement of the fingers of the pathology hand
Arm Title
Surgery
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Surgery and Neural mobilization
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Neural Mobilization
Intervention Description
neural exercise Will be performed in the patients
Intervention Type
Procedure
Intervention Name(s)
Surgery
Intervention Description
open or endoscopic surgery will be permed in the patients with tunnel carpal syndrome
Intervention Type
Procedure
Intervention Name(s)
Surgery and neural mobilization
Intervention Description
following the surgery patients will be treat with neural mobilization exercises.
Primary Outcome Measure Information:
Title
Physiological parameter
Description
Conditioned pain modulation: Diffuse noxious inhibitory control system will be measure with tourniquet test
Time Frame
Change from Baseline Conditioned pain modulation at 6 months
Secondary Outcome Measure Information:
Title
Neuropathic pain
Description
Neuropathic pain Questionnaire DN4
Time Frame
Baseline and 6 months
Title
Pain intensity
Description
Visual analog scale. A 100mm VAS, ranging from 0mm (no pain) to 100mm (worst imaginable pain).
Time Frame
Baseline and 6 months
Title
Pain expansion
Description
Body pain maps
Time Frame
Change from baseline and 6 months
Title
Pressure pain threshold
Description
Three consecutive trials of pressure pain threshold on the active trigger point at a rate of 1 kg/sec at intervals of 30 seconds were conducted.
Time Frame
Baseline and 6 months
Title
Psychological factors_Anxiety
Description
State Trait Anxiety Inventory (STAI-T)
Time Frame
Baseline and 6 months
Title
Psychological factors_Depression
Description
Beck Depression Inventory (BDI-II)
Time Frame
Baseline and 6 months
Title
Psychological factors_Kinesiophobia
Description
Tampa Scale for Kinesiophobia.. The score goes from 11 to 44. A higher value indicates a worse outcome.
Time Frame
Baseline and 6 months
Title
Psychological factors_catastrophizing
Description
Pain Catastrophizing Scale. The scores goes from 0 to 52. A higher value indicates a worse outcome.
Time Frame
Baseline and 6 months
Title
Psychological factors_Fear avoidance
Description
Fear Avoidance Belief Questionnaire (FABQ)
Time Frame
Baseline and 6 months
Title
Disability_DASH
Description
Disabilities of Arm, Shoulder and Hand (DASH)
Time Frame
Baseline and 6 months
Title
Disability_BOSTON
Description
Boston Carpal Tunnel Questionnaire
Time Frame
Baseline and 6 months
Title
Strength_grip
Description
grip strength without pain
Time Frame
Baseline and 6 months
Title
Strength_pinch
Description
pinch strength
Time Frame
Baseline and 6 months

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Josué Fernández, PhD
Phone
34914888949
Email
josue.fernandez@urjc.es
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Matesanz
Phone
675042482
Email
luis.matesanzgarcia@gmail.com
Facility Information:
Facility Name
Universidad Rey Juan Carlos
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josué Fernández, PhD
Phone
34914888949
Email
josue.fernandez@urjc.com

12. IPD Sharing Statement

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Neural Exercises vs Surgery in Patients With Carpal Tunnel Syndrome

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