Efficacy of Extracorporeal Shock Wave Therapy, LASER Therapy and Cryotherapy in Patients Having Sacroiliitis

Not Applicable

Recruiting

• Conditions: Sacroilitis
• Interventions: Other: shock wave therapy; Other: Cryotherapy; Other: LASER Therapy; Other: Exercises

• Registration Number: NCT06569615
• Lead Sponsor: Najran University

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.

Study Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-21
• Study First Posted: 2024-08-26
• Study Start: 2024-08-27
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2025-02-27
• Study Completion: 2025-02-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	shock wave therapy	shock wave Group
Group 3	Cryotherapy	Cryotherapy Group
Group 2	Exercises	LASER Group
Group 2	LASER Therapy	LASER Group
Group 1	Exercises	shock wave Group
Group 3	Exercises	Cryotherapy Group

Primary Outcome Measures

Name	Time	Method
Pain Pressure Threshold (PPT)	8 Weeks	Pain pressure threshold of muscle tenderness will be measured by using the algometer
Pain Intensity	8 Weeks	Pain intensity will be measured by using the Visual Analogue Scale (VAS),a linear scale wherein patients indicate their pain intensity on a 10 cm line ranging from 'no pain' to 'worst imaginable pain'

Secondary Outcome Measures

Name	Time	Method
Functional Disability	8 Weeks	Functional disability will be measured by using the Oswestry Disability Index (ODI),a validated 10-item questionnaire evaluating various dimensions of daily living

Trial Locations

Locations (1)

Hashim Ahmed; 🇸🇦 Najrān, Najran, Saudi Arabia