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

Efficacy of Extracorporeal Shock Wave Therapy, LASER Therapy and Cryotherapy on PPT, Pain and Functional Disability in Patients Having Sacroiliitis: A Randomized Control Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06569615
Enrollment
60
Registered
2024-08-26
Start date
2024-08-27
Completion date
2026-09-10
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sacroilitis

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.

Interventions

OTHERshock wave therapy

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.

OTHERLASER Therapy

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.

OTHERCryotherapy

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.

OTHERExercises

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.

Sponsors

Najran University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
20 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain Pressure Threshold (PPT)8 WeeksPain pressure threshold of muscle tenderness will be measured by using the algometer
Pain Intensity8 WeeksPain 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

MeasureTime frameDescription
Functional Disability8 WeeksFunctional disability will be measured by using the Oswestry Disability Index (ODI),a validated 10-item questionnaire evaluating various dimensions of daily living

Countries

Saudi Arabia

Contacts

CONTACTHashim Ahmed, PhD
hahasan@nu.edu.sa+966507589062
PRINCIPAL_INVESTIGATORHashim Ahmed, PhD

Assistant Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026