Clinical trial NCT05920486: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Sacroiliac Arthritis
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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:

  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

Primary outcomes:
measure: Changes in Pain intensity
timeFrame: Changes in Pain intensity Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
measure: Changes in Functional ability
timeFrame: Changes in Functional ability Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
Secondary outcomes:
measure: Global Perceived Effect (Global Perceived Effect Scale)
timeFrame: Measured at week 8 and week 12 (follow-up)
measure: Changes in Range of Motion in the Lumbopelvic Region (Modified Schober Test and Hip Flexion/Extension)
timeFrame: Changes in Range of Motion Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
measure: Changes in Health-Related Quality of Life (Short Form 36 Health Survey)
timeFrame: Changes in Health-Related Quality of Life Measured at baseline, week 4, week 8 (end of treatment), and week 12 (follow-up)
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Cairo University
name: Amal Fawzy, Ph.d
role: STUDY_DIRECTOR
References: