Effects of serial locoregional water-filtered infrared A radiation on ankylosing spondylitis - a clinical randomized controlled trial
- Conditions
- M45.0
- Registration Number
- DRKS00021257
- Lead Sponsor
- Campus Kerckhoff der Justus-Liebig-Universität Gießen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 71
All patients aged 18 to 80 with axSpA fulfilling the ASAS classification criteria on stable non-steroidal anti-inflammatory drug (NSAID) therapy or stable non-pharmacological therapy for at least 4 weeks priorly with moderate disease activity defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of 4 to 7 receiving an inpatient 7-day multimodal rheumatologic complex treatment (MRCT) were eligible.
Patients are excluded if they receive glucocorticoids (systemic or local) and/or conventional synthetic (cs)- and/or biologic (b-) disease-modifying antirheumatic drugs (DMARDs) treatment or due to disease manifestation have now the need for any of these treatments. Patients with contraindications to hyperthermia (e.g. sensitivity disorders, heat intolerance, therapy with photosensitizing drugs, heat urticaria, new manifested hematomas, severe (chronic) kidney injury or severe (chronic) heart failure or acute infections are excluded as well.
Lack of German knowledge.
Lack of adherence.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in pain level measured on a numerical ranking scale (0 to 10) before (baseline, T0) and after 6 days of asl-wIRAS therapy (T1)
- Secondary Outcome Measures
Name Time Method Change in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) before (day 0) and after (day 6) a 6-day asl-wIRAS therapy.<br><br>Change in Bath Ankylosing Spondylitis Disease Functional Index (BASFI) before and after 6 days of asl-wIRAS therapy.<br><br><br>Change in Bath Ankylosing Spondylitis Patient Global Score (BAS-G) before and after 6 days of asl-wIRAS therapy. <br><br>Change in the level of Tumour Necrosis Factor-alpha, Interleukin 1, -6 and -10 before and after 6 days of asl-wIRAS therapy.<br><br>Change of painlevels measured on a numeric Rating scale (0-10) between baseline (T0), 2 days of internvention (T2), 5 days of Intervention (T3) and after Trial completion (T1). Pain will be assessed before and after a Intervention at those time Points.