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Therapeutic Exercise to Treat Neuropathic Pain (Aps)

Primary Purpose

Gaucher Disease, Fabry Disease

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic Exercise
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gaucher Disease focused on measuring Gaucher Disease, Exercise, Terapheutic

Eligibility Criteria

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

Inclusion criteria:

  • Female or male patients between 18 years and 65 years.
  • Patients diagnosed by a doctor specializing in Fabry disease with FabryScan.
  • Fabry's disease must have a stable evolution, with a disease severity scoring system (DS3) that must be less than 8 points per year in the last 2-3 years.
  • Presence of neuropathic pain with a score greater than or equal to 4 in the "Douleur neuropathique (DN4)" questionnaire.

Exclusion criteria:

  • Patients with an acute cardiovascular disease or with a heart or kidney transplant.
  • Subjects with acute orthopedic problems that limit their participation in the study.
  • Subjects with cognitive impairments that prevent them from filling in the questionnaires or understanding the exercises to be performed.

Sites / Locations

  • FEETEG

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Exercise group

Arm Description

Exercise programme 3 times/week.

Outcomes

Primary Outcome Measures

Neurophatic pain
DN4. This tool allows to estimate the probability of neuropathic pain of the patient in a valid and reliable way. It consists of 4 questions with 10 items to fill out. The researcher directly asks the patient and it is the investigator who completes the questionnaire. To each item, you must provide a "yes" or "no" answer; the "yes" is worth 1 point and the "no" is worth 0 point. At the end of the questionnaire, the investigator counts the patient's score on 10. If the patient's score is equal to or greater than 4 out of 10, the test is positive.

Secondary Outcome Measures

Functionality
Arm Functionality DASH. The DASH questionnaire is a tool for assessing and measuring the functionality of the upper limb that the patient perceives during daily activities. This questionnaire is used in several studies with patients with disabilities in the hand, elbow and shoulder. It is valid, reliable and capable of detecting changes.
Legs' strenght
Test of rising and sitting of the chair during 30 seconds as many times as possible.
Strenght of the extensor muscless of the trunk
BST. Biering-Sorensen test.The test is to keep the trunk in prone position as long as possible to assess the resistance of the trunk extensor musculature.
Strenght of the inclination muscless of the trunk
TSB. Test Side-Bridge assesses the resistance of the inclination muscles or lateral flexors of the trunk. In it the participants are placed in lateral recumbency on their dominant side in a mat. In this position, the participants support themselves with the elbow and the forearm of their dominant side and raise the pelvis until the trunk is aligned with the lower extremities. The test consists of maintaining the referred position as long as possible.
Strenght of the flexor muscless of the trunk
ITo. To assess the resistance of the flexor muscles of the trunk, the participants are placed supine with the hips and knees bent at 90º. The participants flex the upper part of the trunk until they touch the thighs with the elbows, keeping the cervical spine in a neutral position.
Visual Analogue Scale
VAS. The analog visual pain scale is a tool that is used to assess the pain perceived by the patient in a valid and reliable way. It is an instrument for measuring the intensity of pain that represents a horizontal line of 10 cm with a score of 0 to 10, where 0 represents non-pain and 10 unbearable pain. The patient should place a vertical line on the horizontal line of the scale where he places his pain intensity.
Hospital, anxiety and depression questionnaire
HADS. This questionnaire allows to evaluate the psychosocial factors of the patient, through 14 questions with two subscales of 7 questions (one subscale on anxiety and the other on depression); The patient must answer one of the 4 items of each question without much reflection to have a real answer of how he was during the past week. The intensity or frequency of symptoms is evaluated with a Likert scale ranging from 0 to 3. In each subscale (anxiety and depression) the points are added and interpreted as such: 0-7 points: normal; 8-10 points: doubtful and higher than 11: clinical problem. This tool is validly and reliably used in clinical practice.
SF-36
This questionnaire assesses the quality of life perceived by the patient. It is widely used in clinical practice and is approved as valid and reliable. There are 36 questions with 2,3,5 or 6 items in each question and with an assessment between 0 and 100. The questions assess physical function, function limitations due to physical health problems, body aches, general health, vitality, social functioning and emotional and mental health problems
Semmes Weinstein monofilament test
The Semmes Weinstein monofilament test is a tool that evaluates tactile and pressure sensitivity in a valid and reliable way. A nylon filament attached to a handle is used which, when folded, applies a constant pressure of 10g. The investigator applies the monofilament perpendicular to the skin with increased pressure until the monofilament bends and without supporting it for more than 1 or 2 seconds. The test will be performed on the sole of the foot in 4 points: the first toe, the base of the first, third and fifth metatarsals. When the patient notices something, he puts a 1 and a 0 if he does not notice something. The sensitivity index is obtained with the sum of the values and is considered a sensitive patient only when it has a score of 8/8.

Full Information

First Posted
April 23, 2019
Last Updated
December 14, 2020
Sponsor
Universidad de Zaragoza
Collaborators
fundación española para el estudio y tratamiento de la Enfermedad de Gaucher y otras lisosomales, Fundación San Valero, Fundación Ibercaja
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1. Study Identification

Unique Protocol Identification Number
NCT04050137
Brief Title
Therapeutic Exercise to Treat Neuropathic Pain
Acronym
Aps
Official Title
Therapeutic Exercise to Treat Neuropathic Pain in Patients With Chronic Lisosomal Injuries: Learning and Service Project
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
December 14, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
Collaborators
fundación española para el estudio y tratamiento de la Enfermedad de Gaucher y otras lisosomales, Fundación San Valero, Fundación Ibercaja

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
A quasi-experimental, prospective clinical trial with pre and post intervention measurements, whose porpuose is assess the efficacy of a therapeutic exercise protocol to treat neuropathic pain in Fabry Disease.
Detailed Description
There take part in this study women or men aged between 18 and 65 years, with a diagnosys by a physician specializing in Fabry disease with FabryScan. Patients must present a stable evolution, with a scoring system of disease severity (DS3) that must be less than 8 points per year in the last 2-3 years and they have to presence of neuropathic pain with a score greater than or equal to 4 in the questionnaire "Douleur neuropathique (DN4)".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gaucher Disease, Fabry Disease
Keywords
Gaucher Disease, Exercise, Terapheutic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise group
Arm Type
Experimental
Arm Description
Exercise programme 3 times/week.
Intervention Type
Other
Intervention Name(s)
Therapeutic Exercise
Intervention Description
Patients who meet the inclusion criteria and who want to carry out the workshops, fill out an informed consent explaining the procedure to be followed and accepting the cessation of data to carry out the study. Patients will be divided into 2 working groups (approximately 10 patients in total, in a Gaucher disease group and in another Fabry disease). The workshops will be held at the foundation twice a month in sessions of 45 minutes of work for 3 months (May, June, July 2019). In these sessions the physiotherapists will show the new exercises to the patients. The exercises that are taught in that session should be done at home 3 times a week. In addition, a document will be delivered with the exercises to be carried out and the frequency and intensity of execution. The workshops will be guided at all times by a physiotherapist specialized in therapeutic exercise and EDL.
Primary Outcome Measure Information:
Title
Neurophatic pain
Description
DN4. This tool allows to estimate the probability of neuropathic pain of the patient in a valid and reliable way. It consists of 4 questions with 10 items to fill out. The researcher directly asks the patient and it is the investigator who completes the questionnaire. To each item, you must provide a "yes" or "no" answer; the "yes" is worth 1 point and the "no" is worth 0 point. At the end of the questionnaire, the investigator counts the patient's score on 10. If the patient's score is equal to or greater than 4 out of 10, the test is positive.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Functionality
Description
Arm Functionality DASH. The DASH questionnaire is a tool for assessing and measuring the functionality of the upper limb that the patient perceives during daily activities. This questionnaire is used in several studies with patients with disabilities in the hand, elbow and shoulder. It is valid, reliable and capable of detecting changes.
Time Frame
8 weeks
Title
Legs' strenght
Description
Test of rising and sitting of the chair during 30 seconds as many times as possible.
Time Frame
8 weeks
Title
Strenght of the extensor muscless of the trunk
Description
BST. Biering-Sorensen test.The test is to keep the trunk in prone position as long as possible to assess the resistance of the trunk extensor musculature.
Time Frame
8 weeks
Title
Strenght of the inclination muscless of the trunk
Description
TSB. Test Side-Bridge assesses the resistance of the inclination muscles or lateral flexors of the trunk. In it the participants are placed in lateral recumbency on their dominant side in a mat. In this position, the participants support themselves with the elbow and the forearm of their dominant side and raise the pelvis until the trunk is aligned with the lower extremities. The test consists of maintaining the referred position as long as possible.
Time Frame
8 weeks
Title
Strenght of the flexor muscless of the trunk
Description
ITo. To assess the resistance of the flexor muscles of the trunk, the participants are placed supine with the hips and knees bent at 90º. The participants flex the upper part of the trunk until they touch the thighs with the elbows, keeping the cervical spine in a neutral position.
Time Frame
8 weeks
Title
Visual Analogue Scale
Description
VAS. The analog visual pain scale is a tool that is used to assess the pain perceived by the patient in a valid and reliable way. It is an instrument for measuring the intensity of pain that represents a horizontal line of 10 cm with a score of 0 to 10, where 0 represents non-pain and 10 unbearable pain. The patient should place a vertical line on the horizontal line of the scale where he places his pain intensity.
Time Frame
8 weeks
Title
Hospital, anxiety and depression questionnaire
Description
HADS. This questionnaire allows to evaluate the psychosocial factors of the patient, through 14 questions with two subscales of 7 questions (one subscale on anxiety and the other on depression); The patient must answer one of the 4 items of each question without much reflection to have a real answer of how he was during the past week. The intensity or frequency of symptoms is evaluated with a Likert scale ranging from 0 to 3. In each subscale (anxiety and depression) the points are added and interpreted as such: 0-7 points: normal; 8-10 points: doubtful and higher than 11: clinical problem. This tool is validly and reliably used in clinical practice.
Time Frame
8 weeks
Title
SF-36
Description
This questionnaire assesses the quality of life perceived by the patient. It is widely used in clinical practice and is approved as valid and reliable. There are 36 questions with 2,3,5 or 6 items in each question and with an assessment between 0 and 100. The questions assess physical function, function limitations due to physical health problems, body aches, general health, vitality, social functioning and emotional and mental health problems
Time Frame
8 weeks
Title
Semmes Weinstein monofilament test
Description
The Semmes Weinstein monofilament test is a tool that evaluates tactile and pressure sensitivity in a valid and reliable way. A nylon filament attached to a handle is used which, when folded, applies a constant pressure of 10g. The investigator applies the monofilament perpendicular to the skin with increased pressure until the monofilament bends and without supporting it for more than 1 or 2 seconds. The test will be performed on the sole of the foot in 4 points: the first toe, the base of the first, third and fifth metatarsals. When the patient notices something, he puts a 1 and a 0 if he does not notice something. The sensitivity index is obtained with the sum of the values and is considered a sensitive patient only when it has a score of 8/8.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Female or male patients between 18 years and 65 years. Patients diagnosed by a doctor specializing in Fabry disease with FabryScan. Fabry's disease must have a stable evolution, with a disease severity scoring system (DS3) that must be less than 8 points per year in the last 2-3 years. Presence of neuropathic pain with a score greater than or equal to 4 in the "Douleur neuropathique (DN4)" questionnaire. Exclusion criteria: Patients with an acute cardiovascular disease or with a heart or kidney transplant. Subjects with acute orthopedic problems that limit their participation in the study. Subjects with cognitive impairments that prevent them from filling in the questionnaires or understanding the exercises to be performed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Royo
Organizational Affiliation
Universidad San Jorge
Official's Role
Principal Investigator
Facility Information:
Facility Name
FEETEG
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

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Therapeutic Exercise to Treat Neuropathic Pain

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