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Completed

NCT Number: NCT04050137

Therapeutic Exercise to Treat Neuropathic Pain

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.

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Key information

Conditions

Gaucher Disease Behavior Brain Diseases Brain Diseases, Metabolic Brain Diseases, Metabolic, Inborn Cardiovascular Diseases Central Nervous System Diseases Cerebral Small Vessel Diseases Cerebrovascular Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Fabry Disease Genetic Diseases, Inborn Genetic Diseases, X-Linked Lipid Metabolism Disorders Lipid Metabolism, Inborn Errors Lipidoses Lysosomal Storage Diseases Lysosomal Storage Diseases, Nervous System Metabolic Diseases Metabolism, Inborn Errors Motor Activity Nervous System Diseases Nutritional and Metabolic Diseases Sphingolipidoses Vascular Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FEETEG

Zaragoza, Spain

About this study

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)".

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic exercise

Other

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 outcomes

  1. Neurophatic pain

    Time frame: 8 weeks

    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 outcomes

  1. Functionality

    Time frame: 8 weeks

    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.

  2. Legs' strenght

    Time frame: 8 weeks

    Test of rising and sitting of the chair during 30 seconds as many times as possible.

  3. Strenght of the extensor muscless of the trunk

    Time frame: 8 weeks

    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.

  4. Strenght of the inclination muscless of the trunk

    Time frame: 8 weeks

    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.

  5. Strenght of the flexor muscless of the trunk

    Time frame: 8 weeks

    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.

  6. Visual Analogue Scale

    Time frame: 8 weeks

    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.

  7. Hospital, anxiety and depression questionnaire

    Time frame: 8 weeks

    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.

  8. SF-36

    Time frame: 8 weeks

    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

  9. Semmes Weinstein monofilament test

    Time frame: 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Collaborators

  • Fundación Ibercaja
  • Fundación San Valero
  • fundación española para el estudio y tratamiento de la Enfermedad de Gaucher y otras lisosomales

Registry information

Official study title

Therapeutic Exercise to Treat Neuropathic Pain in Patients With Chronic Lisosomal Injuries: Learning and Service Project

Acronym: Aps

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 8, 2019
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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