Therapeutic Exercise to Treat Neuropathic Pain

NCT04050137 | Completed

• 1 other identifier: PI19/205
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Gaucher Disease; Fabry Disease

Keywords

Gaucher Disease; Exercise; Terapheutic

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (9)

• Functionality

  8 weeks

• Legs' strenght

  8 weeks

• Strenght of the extensor muscless of the trunk

  8 weeks

• Strenght of the inclination muscless of the trunk

  8 weeks

• Strenght of the flexor muscless of the trunk

  8 weeks

Study Arms (1)

Exercise group

EXPERIMENTAL

Exercise programme 3 times/week.

Other: Therapeutic Exercise

Interventions

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.

Exercise group

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Zaragoza: lead
• fundación española para el estudio y tratamiento de la Enfermedad de Gaucher y otras lisosomales: collaborator
• Fundación San Valero: collaborator
• Fundación Ibercaja: collaborator

Study Sites (1)

FEETEG

Zaragoza, Spain

Location

MeSH Terms

Conditions

Gaucher Disease; Fabry Disease; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Royo

  Universidad San Jorge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: August 8, 2019
• Study Start: May 2, 2019
• Primary Completion: December 1, 2020
• Study Completion: December 14, 2020
• Last Updated: December 16, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)