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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое shock 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.
• Другое LASER 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.
• Другое Cryotherapy
  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.
• Другое Exercises
  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

Первичные конечные точки

• Pain Pressure Threshold (PPT) [Срок оценки: 8 Weeks]
• Pain Intensity [Срок оценки: 8 Weeks]

Вторичные конечные точки (1)

• Functional Disability [Срок оценки: 8 Weeks]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Саудовская Аравия · 1 центр

• Hashim Ahmed — Najran

Идентификаторы

NCT: NCT06569615 · 202406-076-021198-048523

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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