RecruitingNot Applicable

Laser Therapy in the Isotretinoin-Induced Sacroiliitis

Turkey (Türkiye)50 participantsStarted 2025-11-24

Plain-language summary

The clinical significance of this adverse effect lies in its impact on quality of life and the potential for misdiagnosis. The symptomatology can be severe enough to limit daily activities and may be mistakenly attributed to a primary rheumatic disease, leading to unnecessary long-term immunosuppressive therapy if the temporal link to isotretinoin is not identified. Therefore, a high index of suspicion is crucial for dermatologists, rheumatologists, and primary care physicians alike. Aim: To compare the effectiveness of High-Intensity Laser Therapy (HILT) in reducing pain intensity, in patients diagnosed with Isotretinoin-Induced Sacroiliitis.

Who can participate

Age range18 Years – 35 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Aged between 18 and 35 years. * Receiving a stable dose of oral isotretinoin (e.g., 0.3-0.5 mg/kg/day) for at least one month. * Diagnosis of sacroiliitis based on: Clinical symptoms: Persistent (≥4 weeks) lower back/buttock pain, morning stiffness \>30 minutes, improvement with exercise. Positive physical findings: At least two positive sacroiliac joint provocation tests (e.g., FABER/Patrick's test, Gaenslen's test, Compression/Distraction test). Radiological confirmation (MRI): Active inflammation (bone marrow edema) on Short-Tau Inversion Recovery (STIR) sequences in one or both sacroiliac joints. * A baseline pain intensity of ≥4 on the Visual Analog Scale (VAS 0-10 cm). Exclusion Criteria: * ankylosing spondylitis or other seronegative spondyloarthritis * the presence of pregnancy * the presence of any cancer * the presence of multiple sclerosis

What they're measuring

Visual Analog Scale

Timeframe: will be performed at Baseline (T0), immediately after the 4-week intervention period (T1), and at a 1-month follow-up (T2) to assess sustainability.

Pain Intensity

Timeframe: will be performed at Baseline (T0), immediately after the 4-week intervention period (T1), and at a 1-month follow-up (T2) to assess sustainability.

Trial details

NCT IDNCT07264153

SponsorUşak University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-04-11

Contact for this trial

Ali Y Karahan, Professor

+905386921934 ali.karahan@usak.edu.tr

View on ClinicalTrials.gov More Sacroilitis trials

Plain-language summary

Who can participate

Age range18 Years – 35 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Visual Analog Scale

Timeframe: will be performed at Baseline (T0), immediately after the 4-week intervention period (T1), and at a 1-month follow-up (T2) to assess sustainability.

Pain Intensity

Timeframe: will be performed at Baseline (T0), immediately after the 4-week intervention period (T1), and at a 1-month follow-up (T2) to assess sustainability.