Laser Therapy in the Isotretinoin-Induced Sacroiliitis
ConditionSacroilitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-35
SponsorUşak University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
ankylosing spondylitis or other seronegative spondyloarthritis
the presence of pregnancy
the presence of any cancer
the presence of multiple sclerosis
Trial design
Design model
Parallel
Treatments tested in this trial
Laser Therapy
DeviceProtocol 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.
Exercises for both groups
Other interventionParticipants 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Laser Therapy Group (LTG)Experimental treatment 2 interventions
Group B: Sham Therapy Group (STG)Sham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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."
Time frame
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.2
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.
Time frame
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.Sponsors and contacts
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Source ClinicalTrials.gov