Back to resultsHigh-Intensity Laser Therapy in Patients With Sacroiliitis
Primary Purpose
Sacroiliac Arthritis
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
High-Intensity Laser Therapy (HILT)
Sham High-Intensity Laser Therapy (HILT)
Sponsored by
About this trial
This is an interventional treatment trial for Sacroiliac Arthritis
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
High-Intensity Laser Therapy (HILT) Group
Sham-Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05920486
Brief Title
High-Intensity Laser Therapy in Patients With Sacroiliitis
Official Title
The Effectiveness of High-Intensity Laser Therapy in Reducing Pain and Improving Function in Patients With Sacroiliitis: A Sham-Controlled Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 22, 2023 (Anticipated)
Primary Completion Date
March 22, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Triple blinded
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High-Intensity Laser Therapy (HILT) Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham-Control Group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High-Intensity Laser Therapy (HILT)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham High-Intensity Laser Therapy (HILT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Pain intensity
Description
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.
Time Frame
Changes in Pain intensity Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
Title
Changes in Functional ability
Description
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.
Time Frame
Changes in Functional ability Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
Secondary Outcome Measure Information:
Title
Global Perceived Effect (Global Perceived Effect Scale)
Description
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.
Time Frame
Measured at week 8 and week 12 (follow-up)
Title
Changes in Range of Motion in the Lumbopelvic Region (Modified Schober Test and Hip Flexion/Extension)
Description
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.
Time Frame
Changes in Range of Motion Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
Title
Changes in Health-Related Quality of Life (Short Form 36 Health Survey)
Description
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.
Time Frame
Changes in Health-Related Quality of Life Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Fawzy, Ph.d
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
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High-Intensity Laser Therapy in Patients With Sacroiliitis
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