Does Balnotherapy Influence the Qualitiy of Life in SLE

NCT ID: NCT04392791

Last Updated: 2022-09-29

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2020-12-01

Brief Summary

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

The aim of this study was to investigate the effects of balneotherapy on the quality of life and on work productivity of SLE patients.

Detailed Description

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

SLE patients in remission/low disease activity of three immunology centers were included in this randomized, controlled, follow-up study. In addition to the standard of care (SOC) sixteen out of the thirty SLE patients received balneotherapy (15 times, for 30 minutes) and fourteen patients received the SOC only. Prevalidated survey instruments including LupusQol, SF36, and WPAI questionnaires were recorded.

Conditions

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

SLE

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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

Treated group

The participants received thermal water therapy

Group Type ACTIVE_COMPARATOR

balneotherapy

Intervention Type OTHER

Balneotherapy, a medical remedy, with medically and legally recognized mineral waters for therapeutic and rehabilitation purposes

Control group

The participants haven't received thermal water therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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

balneotherapy

Balneotherapy, a medical remedy, with medically and legally recognized mineral waters for therapeutic and rehabilitation purposes

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* diagnosis of SLE according to SLICC/ACR, 2012 criteria;
* remission or low disease activity, evaluated with SLEDAI-2K

Exclusion Criteria

* explorable psychiatric disease
* general contraindications to balneotherapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

University of Debrecen

OTHER

Sponsor Role collaborator

Szeged University

OTHER

Sponsor Role collaborator

Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

OTHER

Sponsor Role lead

Responsible Party

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

Tamás Bender MD, PhD. DSC

MD, PhD. DSC Head of Phisioterapy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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

Tamás Bender, MD, PhD. DSC

Role: PRINCIPAL_INVESTIGATOR

Locations

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

Polyclinic of Hospitaller Brothers of St. John of God

Budapest, , Hungary

Site Status

Countries

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

Hungary

Other Identifiers

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

31959-2/2017/EKU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Interleukin23 in Systemic Lupus
NCT06713187 RECRUITING NA