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

NCT06569615 | Recruiting

• 1 other identifier: 202406-076-021198-048523
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sacroilitis

Outcome Measures

Primary Outcomes (2)

• Pain Pressure Threshold (PPT)

  Pain pressure threshold of muscle tenderness will be measured by using the algometer

  8 Weeks

• Pain Intensity

  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'

  8 Weeks

Secondary Outcomes (1)

• Functional Disability

  8 Weeks

Study Arms (3)

Group 1

EXPERIMENTAL

shock wave Group

Other: shock wave therapy; Other: Exercises

Group 2

EXPERIMENTAL

LASER Group

Other: LASER Therapy; Other: Exercises

Group 3

EXPERIMENTAL

Cryotherapy Group

Other: Cryotherapy; Other: Exercises

Interventions

shock wave therapy OTHER

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: Participants will be given Radial shockwave therapy, (Storz Medical Shock Master MP200 device) for 10 minutes/session, one session/week, for 8 weeks.

Group 1

LASER Therapy OTHER

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: Participants will be given LASER, (LEVELASER EZ1 EASYONE) over the lumbosacral area for 10 minutes/Session, three session/week, for 8 weeks.

Group 2

Cryotherapy OTHER

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: Participants will be given Cryotherapy, (Gymna UniphyCryoflow 1000 IR Shock Master ICE-CT device) over the lumbosacral area for 10 minutes/Session, three session/week, for 8 weeks.

Group 3

Exercises OTHER

The assigned exercises for all participants will include 1. Bilateral bridging, 2. Knee to chest, 3. Back extension within a pain-free range, 4. Plank, 5. Baby pose stretch, 6. Cat and camel, 7. Bilateral adductor ball squeezes and 8. Stretching exercise (Gluteal /Piriformis stretch, Quads /Hams stretch. The treatment plan involved performing three sets of exercises, with each set comprising 8 to 10 repetitions. 20-30 minutes of exercise session will be conducted three times per week over a span of 8 weeks.

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Najran University: lead

Study Sites (1)

Hashim Ahmed

Najran, Najran Region, 1988, Saudi Arabia

RECRUITING

MeSH Terms

Interventions

Extracorporeal Shockwave Therapy; Laser Therapy; Cryotherapy; Exercise

Intervention Hierarchy (Ancestors)

Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Physical Therapy Modalities; Rehabilitation; Ablation Techniques; Surgical Procedures, Operative; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Hashim Ahmed, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hashim Ahmed, PhD

CONTACT

+966507589062; hahasan@nu.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 26, 2024
• Study Start: August 27, 2024
• Primary Completion: May 7, 2026
• Study Completion: May 7, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)