Does Balnotherapy Influence the Qualitiy of Life in SLE

SLE Clinical Trial

Official title:

Balnotherapy in SLE, the First Randomised Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392791
• Other study ID #: 31959-2/2017/EKU
• Status: Completed
• Phase: N/A
• Start date: December 1, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: September 2022
• Source: Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• SLE

Intervention

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

Locations

Country	Name	City	State
Hungary	Polyclinic of Hospitaller Brothers of St. John of God	Budapest

Sponsors (3)

Lead Sponsor	Collaborator
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest	Szeged University, University of Debrecen

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lupus Quality of Life (LupusQoL)	Considering the previous4-week period,34 items comprising eight domains, evaluates the physical health, emotional health, body image, pain, planning, fatigue, intimate relationshipsand burden to others. The scoring is made by domains, ranged from 0 (worst) to 100 (best	10 weeks
Primary	WPAI-Lupus is a disease specific questionnaire developed to measure work capacity and daily activity	Six questions, covering four topics records the prior 7 days impairment: absenteeism, presenteeism, overall work impairment, and activity impairment(Reilly). Evaluation is performed by domain, expressed as a percentage. A higher percentage corresponds to higher impairment, worse productivity.	10 weeks
Primary	The Short Form Health Survey (SF-36)	Evaluatingthe previous four weeks, it contains a total of 36 questions in 8 categories (physical activity, role limitation due to physical problems, physical pain, general health, vitality, social activity, role limitation due to emotional problems, and general mental health). Responses are rated 0-100 per topic, with 0 being the worst and 100 being the best quality of life	10 weeks