Laser Therapy in the Isotretinoin-Induced Sacroiliitis

NCT07264153 | Recruiting

• 1 other identifier: Ayk 2025
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Laser Therapy; Isotretinoin; Sacroiliitis; Pain

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale

  The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

  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

  Algometers are designed to quantify and document levels of tenderness via pressure pain threshold measurement and pain sensitivity via pressure pain tolerance measurement. The manual analogue algometer is a device that is utilised for the measurement of pressure that is applied manually. The device displays a real-time graph of the applied pressure on the analogue screen. The operator employs the use of guidance lines on the analogue screen, thereby enabling the precise application of pressure at the optimal rate. This facilitates the establishment of a highly standardised stimulus.

  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.

Study Arms (2)

Laser Therapy Group (LTG)

EXPERIMENTAL

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.

Device: Laser Therapy; Other: Exercises for both groups

Sham Therapy Group (STG)

SHAM COMPARATOR

Protocol and dosage: In all aspects, including the device's appearance, audible cues (e.g. timer beeps), treatment duration and the physical application of the probe to the skin, the sham protocol will be identical to the active protocol.

Other: Exercises for both groups

Interventions

Laser Therapy DEVICE

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.

Laser Therapy Group (LTG)

Exercises for both groups OTHER

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.

Laser Therapy Group (LTG); Sham Therapy Group (STG)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• ankylosing spondylitis or other seronegative spondyloarthritis
• the presence of pregnancy
• the presence of any cancer
• the presence of multiple sclerosis

Sponsors & Collaborators

• Uşak University: lead

Study Sites (1)

University of Usak

Uşak, 64200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Sacroiliitis; Pain

Interventions

Laser Therapy; Exercise

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Ali Y Karahan, Professor

  Uşak University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Y Karahan, Professor

CONTACT

+905386921934; ali.karahan@usak.edu.tr

Kagan Ozkuk, Professor

CONTACT

+905055601815; kagan.ozkuk@usak.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will be blinded to the treatment allocation (assessor-blinded). The physiotherapist administering the therapy and participants and cannot be blinded due to the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A single-center, prospective, randomized, controlled, parallel-group trial with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: November 24, 2025
• Primary Completion: April 11, 2026
• Study Completion (Estimated): May 11, 2026
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)