High-Intensity Laser Therapy in Patients With Sacroiliitis

Ahram Canadian University

Status: Enrolling

Conditions: Sacroiliac Arthritis

Treatments: Device: High-Intensity Laser Therapy (HILT); Device: Sham High-Intensity Laser Therapy (HILT)

Study type: Interventional

Funder types: Other

Identifiers

NCT05920486

012/020230607

Details and patient eligibility

About

To investigate the effectiveness of High-Intensity Laser Therapy (HILT) in reducing pain and improving function in patients with sacroiliitis, aged 40-60 years.

Enrollment: 64 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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64 participants in 2 patient groups

High-Intensity Laser Therapy (HILT) Group

Experimental group

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.

Treatment:

Device: High-Intensity Laser Therapy (HILT)

Sham-Control Group

Sham Comparator group

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.

Treatment:

Device: Sham High-Intensity Laser Therapy (HILT)