High‑Intensity Laser Therapy for Isotretinoin-Induced Sacroiliitis
Efficacy of High-Intensity Laser Therapy (HILT) in the Management of Isotretinoin-Induced Sacroiliitis: A Randomized Controlled Trial
NA · Uşak University · NCT07264153
This study will try high-intensity laser therapy plus exercises to reduce sacroiliac joint pain in adults who developed sacroiliitis while taking isotretinoin.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 35 Years |
| Sex | All |
| Sponsor | Uşak University (other) |
| Locations | 1 site (Uşak) |
| Trial ID | NCT07264153 on ClinicalTrials.gov |
What this trial studies
Adults aged 18–35 on stable oral isotretinoin with MRI-confirmed sacroiliitis and a baseline pain VAS ≥4 are enrolled. All participants receive an exercise program while the intervention group receives targeted high-intensity laser therapy to the sacroiliac joints, compared to exercises alone. The main outcome is change in pain intensity measured by the Visual Analog Scale, with clinical provocation tests and MRI used for diagnosis and monitoring. The trial focuses on symptom relief and on distinguishing isotretinoin-associated sacroiliitis from primary rheumatic disease to prevent unnecessary long-term immunosuppression.
Who should consider this trial
Good fit: Ideal candidates are 18–35-year-olds on a stable oral isotretinoin dose for at least one month who have MRI-confirmed active sacroiliitis and a baseline pain score of 4 or higher.
Not a fit: Patients with established ankylosing spondylitis or other seronegative spondyloarthropathies, pregnancy, cancer, multiple sclerosis, or sacroiliitis unrelated to isotretinoin are unlikely to benefit.
Why it matters
Potential benefit: If successful, the intervention could reduce SI joint pain and improve daily function, potentially helping patients avoid misdiagnosis and unnecessary immunosuppressive treatment.
How similar studies have performed: High-intensity laser therapy has shown benefit for various musculoskeletal pain conditions, but its specific use for isotretinoin-induced sacroiliitis is novel with limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Uşak
- University of Usak — Uşak, Turkey (Türkiye) (RECRUITING)
Study contacts
- Principal investigator: Ali Y Karahan, Professor — Uşak University
- Study coordinator: Ali Y Karahan, Professor
- Email: ali.karahan@usak.edu.tr
- Phone: +905386921934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Sacroilitis, Laser Therapy, Isotretinoin, Sacroiliitis, Pain