Sacroiliac ArthritisNCT05920486
High-Intensity Laser Therapy in Patients With Sacroiliitis
A study testing High-Intensity Laser Therapy (HILT) in people with Sacroiliac Arthritis, run by Ahram Canadian University at 1 site in Egypt.
Trial summary
To investigate the effectiveness of High-Intensity Laser Therapy (HILT) in reducing pain and improving function in patients with sacroiliitis, aged 40-60 years. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Sacroiliac Arthritis
- What is being tested?
- High-Intensity Laser Therapy (HILT)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jun 2023to 1 Apr 2024
- 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: Adults aged 40-60 years old
- Diagnosis: Confirmed diagnosis of sacroiliitis by a specialist (e.g., rheumatologist, orthopedic surgeon, or radiologist) based on a combination of clinical findings, laboratory tests, and imaging studies
- Clinical findings: Presence of at least one or more of the following clinical signs and symptoms suggestive of sacroiliitis:
- Low back pain, buttock pain, or hip pain, worsened by prolonged sitting, standing, or walking
- Stiffness in the lower back, buttock, or hip region, particularly in the morning or following prolonged inactivity
- Pain improvement with physical activity or exercise
- Duration of symptoms: Experiencing symptoms for at least 3 months
Who cannot join
- Previous surgery or invasive procedures targeting the sacroiliac joints
- Contraindications to physical interventions (e.g., spinal instability, fractures, or severe neurological deficits)
- Presence of other spinal pathologies or systemic inflammatory conditions that could confound the assessment of sacroiliitis (e.g., lumbar disc herniation, ankylosing spondylitis, or rheumatoid arthritis)
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: The Effectiveness of High-Intensity Laser Therapy in Reducing Pain and Improving Function in Patients With Sacroiliitis: A Sham-Controlled Randomized Trial
To investigate the effectiveness of High-Intensity Laser Therapy (HILT) in reducing pain and improving function in patients with sacroiliitis, aged 40-60 years.
- Conditions
- Sacroiliac Arthritis
- Being tested
- High-Intensity Laser Therapy (HILT), Sham High-Intensity Laser Therapy (HILT)
- Medical subject headings
- Arthritis, Sacroiliac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Intensity Laser Therapy (HILT)Device
High-Intensity Laser Therapy (HILT) is a non-invasive treatment that utilizes high-powered lasers to deliver therapeutic doses of energy to damaged tissue. In this study, HILT will be used to treat sacroiliitis, a condition that affects the sacroiliac joint in the lower back and pelvis. HILT will be administered using a Class IV laser with a wavelength of 980 nm, power output of 10 W, spot size of 0.5 cm, and a dose of 60 J/cm2 per session. The laser will be applied to the affected area of the sacroiliac joint, with the aim of achieving a sensation of warmth in the region. The treatment sessions will be delivered for 10 minutes per session, with a total of 12 sessions over 8 weeks. The aim of HILT is to promote cellular repair and regeneration, reduce pain, and improve function in patients with sacroiliitis. Participants in the HILT group will receive HILT treatment as the primary intervention in this study.
Sham High-Intensity Laser Therapy (HILT)Device
Sham HILT is a non-invasive treatment that mimics the appearance and sensation of HILT but does not deliver any laser energy to the affected tissue. In this study, Sham HILT will be used as a control intervention for the treatment of sacroiliitis. The device used for Sham HILT will look and feel the same as the HILT device, but will not emit any laser energy. The device will be applied to the affected area of the sacroiliac joint, with the aim of achieving a sensation of warmth in the region. The treatment sessions will be delivered for 10 minutes per session, with a total of 12 sessions over 8 weeks. The aim of Sham HILT is to provide a credible control intervention that does not have any specific therapeutic effect on the sacroiliac joint. Participants in the Sham HILT group will receive Sham HILT treatment as the primary intervention in this study.
| Study group | Role | What they receive |
|---|---|---|
| High-Intensity Laser Therapy (HILT) Group | Experimental | Participants in the HILT group will receive an 8-week course of High-Intensity Laser Therapy (HILT) for the treatment of sacroiliitis. HILT will be administered using a Class IV laser with a wavelength of 980 nm, power output of 10 W, spot size of 0.5 cm, and a dose of 60 J/cm2 per session. The laser will be applied to the affected area of the sacroiliac joint, with the aim of achieving a sensation of warmth in the region. The treatment sessions will be delivered for 10 minutes per session, with a total of 12 sessions over 8 weeks. Participants will receive no other specific interventions during the study period. Receives: Device: High-Intensity Laser Therapy (HILT) |
| Sham-Control Group | Sham comparator | Participants in the sham-control group will receive a sham HILT treatment for the treatment of sacroiliitis. The sham treatment will be delivered using a device that looks like the HILT device, but does not emit laser energy. The device will be applied to the affected area of the sacroiliac joint, with the aim of achieving a sensation of warmth in the region. The treatment sessions will be delivered for 10 minutes per session, with a total of 12 sessions over 8 weeks. Participants will receive no other specific interventions during the study period. Receives: Device: Sham High-Intensity Laser Therapy (HILT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Pain intensity
The Numeric Pain Rating Scale is a self-reported measure of pain intensity, with a score ranging from 0 (no pain) to 10 (worst pain imaginable). Participants will be asked to rate their pain intensity at rest and during movement of the sacroiliac joint.
Measured: Changes in Pain intensity Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
Changes in Functional ability
The Oswestry Disability Index is a self-reported measure of functional ability, with a score ranging from 0% (no disability) to 100% (maximum disability). Participants will be asked to complete a questionnaire assessing their ability to perform various activities of daily living, such as walking, sitting, and standing.
Measured: Changes in Functional ability Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
Secondary outcomes (3)
Global Perceived Effect (Global Perceived Effect Scale)
The Global Perceived Effect Scale is a self-reported measure of the participant's overall improvement, with a score ranging from -5 (vastly worse) to 5 (completely recovered). Participants will be asked to rate their perceived overall improvement in their condition.
Measured: Measured at week 8 and week 12 (follow-up)
Changes in Range of Motion in the Lumbopelvic Region (Modified Schober Test and Hip Flexion/Extension)
The Modified Schober Test is an objective measure of lumbar flexion, and the Hip Flexion/Extension Test is an objective measure of hip range of motion. These tests will be used to assess changes in range of motion in the lumbopelvic region following the intervention.
Measured: Changes in Range of Motion Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
Changes in Health-Related Quality of Life (Short Form 36 Health Survey)
The Short Form 36 Health Survey is a self-reported measure of health-related quality of life, consisting of 36 items that assess various aspects of physical and mental health. The survey yields scores on eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health.
Measured: Changes in Health-Related Quality of Life Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start22 Jun 2023 (estimated)
- Primary completion22 Mar 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac ArthritisStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920486
- Sponsor's protocol ID
- 012/020230607
- Status last verified
- Jun 2023
- First submitted
- 16 Jun 2023
- Last updated
- 27 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of High-Intensity Laser Therapy in Reducing Pain and Improving Function in Patients With Sacroiliitis: A Sham-Controlled Randomized Trial
- ClinicalTrials.gov ID
- NCT05920486
- Acronym / sponsor ID
- 012/020230607
- Conditions
- Sacroiliac Arthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 22 Jun 2023 (estimated)
- Primary completion
- 22 Mar 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 27 Jun 2023 (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.
To investigate the effectiveness of High-Intensity Laser Therapy (HILT) in reducing pain and improving function in patients with sacroiliitis, aged 40-60 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Intensity Laser Therapy (HILT) Group | Experimental | Device: High-Intensity Laser Therapy (HILT)Participants in the HILT group will receive an 8-week course of High-Intensity Laser Therapy (HILT) for the treatment of sacroiliitis. HILT will be administered using a Class IV laser with a wavelength of 980 nm, power output of 10 W, spot size of 0.5 cm, and a dose of 60 J/cm2 per session. The laser will be applied to the affected area of the sacroiliac joint, with the aim of achieving a sensation of warmth in the region. The treatment sessions will be delivered for 10 minutes per session, with a total of 12 sessions over 8 weeks. Participants will receive no other specific interventions during the study period. |
| Sham-Control Group | Sham comparator | Device: Sham High-Intensity Laser Therapy (HILT)Participants in the sham-control group will receive a sham HILT treatment for the treatment of sacroiliitis. The sham treatment will be delivered using a device that looks like the HILT device, but does not emit laser energy. The device will be applied to the affected area of the sacroiliac joint, with the aim of achieving a sensation of warmth in the region. The treatment sessions will be delivered for 10 minutes per session, with a total of 12 sessions over 8 weeks. Participants will receive no other specific interventions during the study period. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age: Adults aged 40-60 years old
- Diagnosis: Confirmed diagnosis of sacroiliitis by a specialist (e.g., rheumatologist, orthopedic surgeon, or radiologist) based on a combination of clinical findings, laboratory tests, and imaging studies
- Clinical findings: Presence of at least one or more of the following clinical signs and symptoms suggestive of sacroiliitis:
- Duration of symptoms: Experiencing symptoms for at least 3 months
Key exclusion criteria (4 listed)
- Previous surgery or invasive procedures targeting the sacroiliac joints
- Contraindications to physical interventions (e.g., spinal instability, fractures, or severe neurological deficits)
- Presence of other spinal pathologies or systemic inflammatory conditions that could confound the assessment of sacroiliitis (e.g., lumbar disc herniation, ankylosing spondylitis, or rheumatoid arthritis)
- Pregnant or breastfeeding women
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 |
|---|---|---|
| High-Intensity Laser Therapy (HILT)High-Intensity Laser Therapy (HILT) is a non-invasive treatment that utilizes high-powered lasers to deliver therapeutic doses of energy to damaged tissue. In this study, HILT will be used to treat sacroiliitis, a condition that affects the sacroiliac joint in the lower back and pelvis. HILT will be administered using a Class IV laser with a wavelength of 980 nm, power output of 10 W, spot size of 0.5 cm, and a dose of 60 J/cm2 per session. The laser will be applied to the affected area of the sacroiliac joint, with the aim of achieving a sensation of warmth in the region. The treatment sessions will be delivered for 10 minutes per session, with a total of 12 sessions over 8 weeks. The aim of HILT is to promote cellular repair and regeneration, reduce pain, and improve function in patients with sacroiliitis. Participants in the HILT group will receive HILT treatment as the primary intervention in this study. | Device | High-Intensity Laser Therapy (HILT) Group |
| Sham High-Intensity Laser Therapy (HILT)Sham HILT is a non-invasive treatment that mimics the appearance and sensation of HILT but does not deliver any laser energy to the affected tissue. In this study, Sham HILT will be used as a control intervention for the treatment of sacroiliitis. The device used for Sham HILT will look and feel the same as the HILT device, but will not emit any laser energy. The device will be applied to the affected area of the sacroiliac joint, with the aim of achieving a sensation of warmth in the region. The treatment sessions will be delivered for 10 minutes per session, with a total of 12 sessions over 8 weeks. The aim of Sham HILT is to provide a credible control intervention that does not have any specific therapeutic effect on the sacroiliac joint. Participants in the Sham HILT group will receive Sham HILT treatment as the primary intervention in this study. | Device | Sham-Control Group |
Primary outcome
Changes in Pain intensity
Time frame: Changes in Pain intensity Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
The Numeric Pain Rating Scale is a self-reported measure of pain intensity, with a score ranging from 0 (no pain) to 10 (worst pain imaginable). Participants will be asked to rate their pain intensity at rest and during movement of the sacroiliac joint.
Changes in Functional ability
Time frame: Changes in Functional ability Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
The Oswestry Disability Index is a self-reported measure of functional ability, with a score ranging from 0% (no disability) to 100% (maximum disability). Participants will be asked to complete a questionnaire assessing their ability to perform various activities of daily living, such as walking, sitting, and standing.
3 secondary outcomes
Global Perceived Effect (Global Perceived Effect Scale)
Time frame: Measured at week 8 and week 12 (follow-up)
Changes in Range of Motion in the Lumbopelvic Region (Modified Schober Test and Hip Flexion/Extension)
Time frame: Changes in Range of Motion Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
Changes in Health-Related Quality of Life (Short Form 36 Health Survey)
Time frame: Changes in Health-Related Quality of Life Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Individual participant dataSharing planned: No
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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.
Amal Fawzy, Ph.d study director
Cairo 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 High-Intensity Laser Therapy (HILT) in people with Sacroiliac Arthritis, run by Ahram Canadian University at 1 site in Egypt.
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 7 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: status not confirmed, as of the sponsor's last update on 27 Jun 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Pain intensity (time frame: Changes in Pain intensity Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)). 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 27 Jun 2023.