High-Intensity Laser Therapy in Patients With Sacroiliitis

June 17, 2023 updated by: Mohamed Magdy ElMeligie, Ahram Canadian University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Giza
      • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
        • Recruiting
        • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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:

    1. Low back pain, buttock pain, or hip pain, worsened by prolonged sitting, standing, or walking
    2. Stiffness in the lower back, buttock, or hip region, particularly in the morning or following prolonged inactivity
    3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High-Intensity Laser Therapy (HILT) Group
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.
Device: 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.
Sham Comparator: Sham-Control Group
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 Pain intensity Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
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.
Changes in Functional ability Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Perceived Effect (Global Perceived Effect Scale)
Time Frame: Measured at week 8 and week 12 (follow-up)
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 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)
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 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)
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.
Changes in Health-Related Quality of Life Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ahram Canadian University

Investigators

  • Study Director: Amal Fawzy, Ph.d, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 22, 2023

Primary Completion (Estimated)

March 22, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

June 16, 2023

First Submitted That Met QC Criteria

June 17, 2023

First Posted (Actual)

June 27, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2023

Last Update Submitted That Met QC Criteria

June 17, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 012/020230607

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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