Clinical trial NCT06569615: Efficacy of Extracorporeal Shock Wave Therapy, LASER Therapy and Cryotherapy in Patients Having Sacroiliitis
Official title: Efficacy of Extracorporeal Shock Wave Therapy, LASER Therapy and Cryotherapy on PPT, Pain and Functional Disability in Patients Having Sacroiliitis: a Randomized Control Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sacroilitis
Lead sponsor: Najran University
Sponsor class: OTHER
First posted: 2024-08-26
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research aimed to determine the effect of extracorporeal shock wave therapy, LASER therapy and cryotherapy on PPT, Pain and functional disability in patients having Sacroiliitis.

Detailed description: The study will be based on a three-arm parallel group randomized control design. sixty participants of sacroiliitis will be recruited from the Physiotherapy department, at Najran University, K.S.A. Study objectives and procedure will be properly explained and written informed consent will be obtained at the beginning of the study. All the participants will be randomly divided into three groups 1, 2 and 3.

All the participants in first week will receive the ice pack for 15 minutes 3 times a day at the lumbosacral area to reduce inflammation in the area, along with rest to reduce irritation at the lumbosacral area for the first week.

From the 2nd week:

Group 1 will be administered ESWT plus exercise, Group 2 will be administered LASER plus exercise, and Group 3 will be administered cryotherapy and exercise.

Eligibility criteria: Inclusion Criteria:

* Pain in one or both buttocks, hip pain, thigh pain, or even pain more distal.
* Patients may report that their pain is worse after sitting for prolonged periods or with rotational movements that will be intensified when bending laterally or backward and
* Positive outcome in a minimum of three out of five pain-provocation tests (i.e., compression test, distraction test, Faber sign, Gaenslen test, and thigh thrust.
* Pain close to the posterior superior iliac spine and the patient could point with a single finger to the location of pain (Fortin Finger Test).

Exclusion Criteria:

* The Participant who had undergone surgery or experienced significant trauma to the spine, pelvis, lower limb, chest, or abdomen within the past 12 months.
* The participants with lower extremity musculoskeletal disorders, localized spinal pathology, congenital anomalies of the hip, pelvis, or spine that limited mobility.
* having a positive straight leg raising test
* receiving nonsteroidal anti-inflammatory drugs, hormonal therapy, or corticosteroid injections
* individuals with tumors, fractures. ankylosing spondylitis.

Primary outcomes:
measure: Pain Pressure Threshold (PPT)
timeFrame: 8 Weeks
measure: Pain Intensity
timeFrame: 8 Weeks
Secondary outcomes:
measure: Functional Disability
timeFrame: 8 Weeks
Other outcomes:
Locations:
city: Najrān
country: Saudi Arabia
facility: Hashim Ahmed
state: Najran
Study officials:
affiliation: Assistant Professor
name: Hashim Ahmed, PhD
role: PRINCIPAL_INVESTIGATOR
References: