High-Intensity Laser Therapy in Patients With Sacroiliitis

Not Applicable

Recruiting

• Conditions: Sacroiliac Arthritis
• Interventions: Device: Sham High-Intensity Laser Therapy (HILT); Device: High-Intensity Laser Therapy (HILT)

• Registration Number: NCT05920486
• Lead Sponsor: Ahram Canadian University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-06-17
• Last Update Submitted: 2023-06-17
• Study Start: 2023-06-22
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27
• Primary Completion: 2024-03-22
• Study Completion: 2024-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham-Control Group	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.
High-Intensity Laser Therapy (HILT) Group	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.

Primary Outcome Measures

Name	Time	Method
Changes in Pain intensity	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	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.

Secondary Outcome Measures

Name	Time	Method
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)	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)	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.
Global Perceived Effect (Global Perceived Effect Scale)	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.

Trial Locations

Locations (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University; 🇪🇬 Al Ḩayy Ath Thāmin, Giza, Egypt