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NCT Number: NCT06569615

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

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.

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Key information

Conditions

Sacroilitis

Age range

20 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hashim Ahmed

Najran, Najran Region, 1988, Saudi Arabia

Location status: Recruiting

Location contact

Hashim Ahmed, PhD

CONTACT

[email protected]

0507589062

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

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.

Primary outcomes

  1. Pain Pressure Threshold (PPT)

    Time frame: 8 Weeks

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

  2. Pain Intensity

    Time frame: 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 outcomes

  1. Functional Disability

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Hashim Ahmed, PhD

CONTACT

[email protected]

+966507589062

Sponsors and collaborators

Lead sponsor

Najran University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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