Does Balnotherapy Influence the Qualitiy of Life in SLE

Study Overview
=================
Brief 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.

Detailed 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.

Official Title
-----------------
Balnotherapy in SLE, the First Randomised Controlled Study

Conditions
-----------------
SLE

Intervention / Treatment
-----------------
* Other: balneotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treated group<br>The participants received thermal water therapy | Other: balneotherapy<br>* Balneotherapy, a medical remedy, with medically and legally recognized mineral waters for therapeutic and rehabilitation purposes<br>|
| No Intervention: Control group<br>The participants haven't received thermal water therapy | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |