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临床试验/NCT06569615
NCT06569615招募中不适用

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

Najran University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年8月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Pain Pressure Threshold (PPT)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

研究组 & 干预措施

Group 1

Experimental

shock wave Group

干预措施: shock wave therapy (Other)

Group 1

Experimental

shock wave Group

干预措施: Exercises (Other)

Group 2

Experimental

LASER Group

干预措施: LASER Therapy (Other)

Group 2

Experimental

LASER Group

干预措施: Exercises (Other)

Group 3

Experimental

Cryotherapy Group

干预措施: Cryotherapy (Other)

Group 3

Experimental

Cryotherapy Group

干预措施: Exercises (Other)

结局指标

主要结局

Pain Pressure Threshold (PPT)

时间窗: 8 Weeks

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

Pain Intensity

时间窗: 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'

次要结局

  • Functional Disability(8 Weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hashim Ahmed

Assistant Professor

Najran University

研究点 (1)

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