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Effects of serial locoregional water-filtered infrared A radiation on ankylosing spondylitis - a clinical randomized controlled trial

Effects of serial locoregional water-filtered infrared A radiation on ankylosing spondylitis - a clinical randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00021257
Enrollment
76
Registered
2020-04-08
Start date
2017-06-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

M45.0

Interventions

Group 1: Patients with confirmed axial spondylarthritis (axSpA), who in addition to a 7-day multimodal rheumatologic complex therapy receive sl-wIRAR (2 back irradiations with sl-wIRAR daily for 6 day

Sponsors

Campus Kerckhoff der Justus-Liebig-Universität Gießen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Change in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) before (day 0) and after (day 6) a 6-day asl-wIRAS therapy. Change in Bath Ankylosing Spondylitis Disease Functional Index (BASFI) before and after 6 days of asl-wIRAS therapy. Change in Bath Ankylosing Spondylitis Patient Global Score (BAS-G) before and after 6 days of asl-wIRAS therapy. Change in the level of Tumour Necrosis Factor-alpha, Interleukin 1, -6 and -10 before and after 6 days of asl-wIRAS therapy. 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.

Countries

Germany

Contacts

Public ContactPhilipp Klemm

Campus Kerckhoff der Justus Liebig Universität Giessen, Abt. für Rheumatologie, Immunologie, Osteologie und Physikalische Medizin

p.klemm@kerckhoff-klinik.de06032-996-2101

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026