High-Intensity Laser Therapy in Patients With Sacroiliitis

NCT05920486 | Unknown

• 1 other identifier: 012/020230607
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacroiliac Arthritis

Outcome Measures

Primary Outcomes (2)

• 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 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.

  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)

  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)

  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)

  Changes in Health-Related Quality of Life Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)

Study Arms (2)

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.

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.

Device: Sham High-Intensity Laser Therapy (HILT)

Interventions

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.

High-Intensity Laser Therapy (HILT) Group

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.

Sham-Control Group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Arthritis, Sacroiliac

Study Officials

• Amal Fawzy, Ph.d

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Triple blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: June 27, 2023
• Study Start: June 22, 2023
• Primary Completion: March 22, 2024
• Study Completion: April 1, 2024
• Last Updated: June 27, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)