Therapeutic Exercise to Treat Neuropathic Pain

NCT ID: NCT04050137

Last Updated: 2020-12-16

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-02

Study Completion Date

2020-12-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)".

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gaucher Disease Fabry Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Gaucher Disease Exercise Terapheutic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise group

Exercise programme 3 times/week.

Group Type EXPERIMENTAL

Therapeutic Exercise

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Therapeutic Exercise

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

fundación española para el estudio y tratamiento de la Enfermedad de Gaucher y otras lisosomales

UNKNOWN

Sponsor Role collaborator

Fundación San Valero

UNKNOWN

Sponsor Role collaborator

Fundación Ibercaja

UNKNOWN

Sponsor Role collaborator

Universidad de Zaragoza

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Maria Pilar López Royo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Royo

Role: PRINCIPAL_INVESTIGATOR

Universidad San Jorge

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

FEETEG

Zaragoza, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PI19/205

Identifier Type: -

Identifier Source: org_study_id