Actively Recruiting

Phase Not Applicable
Age: 18Years - 35Years
All Genders
NCT07264153

Laser Therapy in the Isotretinoin-Induced Sacroiliitis

Led by Uşak University · Updated on 2025-12-12

50

Participants Needed

1

Research Sites

24 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Laser Therapy in the Isotretinoin-Induced Sacroiliitis

Who Can Participate

Age: 18Years - 35Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 35 years.
  • Receiving a stable dose of oral isotretinoin (0.3-0.5 mg/kg/day) for at least one month.
  • Diagnosed with sacroiliitis based on persistent lower back or buttock pain lasting 4 or more weeks, morning stiffness over 30 minutes, and improvement with exercise.
  • At least two positive sacroiliac joint provocation tests (e.g., FABER/Patrick's test, Gaenslen's test, Compression/Distraction test).
  • Radiological confirmation of active inflammation in one or both sacroiliac joints by MRI STIR sequences.
  • Baseline pain intensity of 4 or higher on the Visual Analog Scale (0-10 cm).
Not Eligible

You will not qualify if you...

  • Diagnosis of ankylosing spondylitis or other seronegative spondyloarthritis.
  • Pregnancy.
  • Presence of any cancer.
  • Presence of multiple sclerosis.

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Usak

Uşak, Turkey (Türkiye), 64200

Actively Recruiting

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Research Team

A

Ali Y Karahan, Professor

CONTACT

K

Kagan Ozkuk, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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