SacroilitisNCT07264153
Laser Therapy in the Isotretinoin-Induced Sacroiliitis
A study testing Laser Therapy and Exercises for both groups in people with Sacroilitis, run by Uşak University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Sacroilitis
- What is being tested?
- Laser Therapy and Exercises for both groups
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Nov 2025to 11 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- ankylosing spondylitis or other seronegative spondyloarthritis
- the presence of pregnancy
- the presence of any cancer
- the presence of multiple sclerosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of High-Intensity Laser Therapy (HILT) in the Management of Isotretinoin-Induced Sacroiliitis: A Randomized Controlled 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.
Read the detailed description
Isotretinoin (13-cis-retinoic acid) is a highly effective retinoid derivative of vitamin A, renowned for its use in the treatment of severe, recalcitrant nodular acne. By significantly reducing sebum production, modulating follicular keratinization, and exerting anti-inflammatory effects, it has proven to be a transformative therapy for patients with conditions unresponsive to conventional treatments. However, its potent biological activity is accompanied by a well-documented and diverse profile of adverse effects, ranging from common mucocutaneous symptoms like xerosis and cheilitis to more serious concerns such as teratogenicity, psychiatric effects, and musculoskeletal complaints.
Among these musculoskeletal adverse events, sacroiliitis-the inflammation of one or both sacroiliac (SI) joints-has emerged as a significant, though potentially underrecognized, clinical entity. The sacroiliac joints, which connect the sacrum to the iliac bones of the pelvis, are a primary site for inflammatory processes seen in spondyloarthropathies (SpA) such as ankylosing spondylitis. The presentation of Isotretinoin-induced sacroiliitis often mirrors that of these idiopathic conditions, characterized by insidious-onset lower back pain, buttock pain, and stiffness that may improve with activity and worsen with rest. Morning stiffness is a common feature, and pain can often be referred to the groin or posterior thigh.
The pathophysiological mechanism linking isotretinoin to sacroiliitis remains incompletely elucidated but is a subject of active investigation. Retinoids are known to modulate the immune system, influencing the differentiation and proliferation of various immune cells. It is hypothesized that isotretinoin may disrupt the delicate balance between pro-inflammatory and anti-inflammatory cytokines, potentially triggering an inflammatory cascade in genetically predisposed individuals. This theory is supported by the observation that symptoms often resolve upon discontinuation of the drug and may recur upon re-challenge, satisfying important criteria for a causal relationship.
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.
Secondary Objectives:
- To assess and compare the improvement in functional status and quality of life between the two intervention groups using validated questionnaires.
- To evaluate and compare the reduction in disease activity and inflammatory symptoms (e.g., morning stiffness, night pain) between the groups.
- To measure and compare the improvement in spinal mobility and specific sacroiliac joint provocation tests.
- To monitor the safety and adverse event profile of HILT in this patient population.
Study Design:
A single-center, prospective, randomized, controlled, parallel-group trial with a 1:1 allocation ratio. 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.
- Conditions
- Sacroilitis
- Being tested
- Laser Therapy, Exercises for both groups
- Keywords
- Laser Therapy, Isotretinoin, Sacroiliitis, Pain
- Medical subject headings
- Sacroiliitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TherapyDevice
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.
Exercises for both groupsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Exercises for both groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start24 Nov 2025
- Primary completion11 May 2026
- Study completion11 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SacroilitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A single-center, prospective, randomized, controlled, parallel-group trial with a 1:1 allocation ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uşak University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Yavuz Karahan, Uşak University
- Investigators
- Ali Y Karahan, Professor, Principal investigator, Uşak University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264153
- Sponsor's protocol ID
- Ayk 2025
- Status last verified
- Jul 2026
- First submitted
- 23 Nov 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. The investigators will publish the results in academic journals.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of High-Intensity Laser Therapy (HILT) in the Management of Isotretinoin-Induced Sacroiliitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07264153
- Acronym / sponsor ID
- Ayk 2025
- Conditions
- Sacroilitis
- Keywords
- Laser Therapy, Isotretinoin, Sacroiliitis, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Uşak UniversityUniversity, hospital or other
- Study start
- 24 Nov 2025 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- 11 Jun 2026 (actual)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Isotretinoin (13-cis-retinoic acid) is a highly effective retinoid derivative of vitamin A, renowned for its use in the treatment of severe, recalcitrant nodular acne. By significantly reducing sebum production, modulating follicular keratinization, and exerting anti-inflammatory effects, it has proven to be a transformative therapy for patients with conditions unresponsive to conventional treatments. However, its potent biological activity is accompanied by a well-documented and diverse profile of adverse effects, ranging from common mucocutaneous symptoms like xerosis and cheilitis to more serious concerns such as teratogenicity, psychiatric effects, and musculoskeletal complaints.
Among these musculoskeletal adverse events, sacroiliitis-the inflammation of one or both sacroiliac (SI) joints-has emerged as a significant, though potentially underrecognized, clinical entity. The sacroiliac joints, which connect the sacrum to the iliac bones of the pelvis, are a primary site for inflammatory processes seen in spondyloarthropathies (SpA) such as ankylosing spondylitis. The presentation of Isotretinoin-induced sacroiliitis often mirrors that of these idiopathic conditions, characterized by insidious-onset lower back pain, buttock pain, and stiffness that may improve with activity and worsen with rest. Morning stiffness is a common feature, and pain can often be referred to the groin or posterior thigh.
The pathophysiological mechanism linking isotretinoin to sacroiliitis remains incompletely elucidated but is a subject of active investigation. Retinoids are known to modulate the immune system, influencing the differentiation and proliferation of various immune cells. It is hypothesized that isotretinoin may disrupt the delicate balance between pro-inflammatory and anti-inflammatory cytokines, potentially triggering an inflammatory cascade in genetically predisposed individuals. This theory is supported by the observation that symptoms often resolve upon discontinuation of the drug and may recur upon re-challenge, satisfying important criteria for a causal relationship.
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.
Secondary Objectives:
- To assess and compare the improvement in functional status and quality of life between the two intervention groups using validated questionnaires.
- To evaluate and compare the reduction in disease activity and inflammatory symptoms (e.g., morning stiffness, night pain) between the groups.
- To measure and compare the improvement in spinal mobility and specific sacroiliac joint provocation tests.
- To monitor the safety and adverse event profile of HILT in this patient population.
Study Design:
A single-center, prospective, randomized, controlled, parallel-group trial with a 1:1 allocation ratio. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A single-center, prospective, randomized, controlled, parallel-group trial with a 1:1 allocation ratio.
| Arm | Type | Receives |
|---|---|---|
| Laser Therapy Group (LTG) | Experimental | Device: Laser Therapy, Other: Exercises for both groupsThe 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. |
| Sham Therapy Group (STG) | Sham comparator | Other: Exercises for both groupsProtocol 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- ankylosing spondylitis or other seronegative spondyloarthritis
- the presence of pregnancy
- the presence of any cancer
- the presence of multiple sclerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser TherapyProtocol 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. | Device | Laser Therapy Group (LTG) |
| Exercises for both groupsParticipants 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. | Other | Laser Therapy Group (LTG), Sham Therapy Group (STG) |
Primary outcome
Visual Analog Scale
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.
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."
Pain Intensity
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No. No individual participant data will be shared. The investigators will publish the results in academic journals.
Related trials for Sacroilitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Y Karahan, Professor principal investigator
Uşak University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Therapy and Exercises for both groups in people with Sacroilitis, run by Uşak University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.