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Laser Therapy in the Isotretinoin-Induced Sacroiliitis

NCT07264153 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-12

No results posted yet for this study

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.

Conditions

  • Sacroilitis

Interventions

DEVICE

Laser Therapy

Protocol and dosage: Treatment will be applied directly over the painful sacroiliac joint(s). The treatment protocol comprised two distinct modes: the first being the administration of analgesic medication, and the second being biostimulation. For the analgesic mode, the laser was administered at an operating power of 10W, with the energy density set at 12J/cm2 across a surface area of 15cm2. The laser will applied in along the right and left sacroiliac joints for four minutes. The total energy delivered will 600 J. In the biostimulation mode, a laser with an operating power of 5 W will applied, generating an energy density of 120 J/cm2 across a surface area of 15 cm2 at the sacroiliac joint line for a duration of 10 minutes, resulting in a total energy output of 3,000 J. Application Technique: The applicator will be moved in a slow, circular, or grid pattern over the target area for 12 minutes.

OTHER

Exercises for both groups

Participants will be taught the supervised exercise programme. Sessions will be held three times per week on non-consecutive days. Each session will last approximately 45 minutes. The exercise programme was designed to address pain and dysfunction related to hypomobility and instability of the sacroiliac joint (SIJ). The intervention comprises a structured, progressive exercise regimen consisting of three sequential phases: 1) Gentle Movement and Relaxation, 2) Specific Self-Mobilisation and 3) Core and Stabilisation. The protocol will be delivered to participants in a standardised format, with progression based on individual tolerance and clinical milestones.

Sponsors & Collaborators

  • Uşak University

    lead OTHER

Principal Investigators

  • Ali Y Karahan, Professor · Uşak University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-24
Primary Completion
2026-04-11
Completion
2026-05-11

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07264153 on ClinicalTrials.gov