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临床试验/NCT03456050
NCT03456050已完成不适用

Effectiveness of a New Therapeutic Technique 'Functional Range Conditioning' in Treating Patients With Chronic Non-specific Low Back Pain

King Saud University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年3月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
Passive range of motion (Hip internal rotation)

研究概览

简要总结

The aims of this study are to examine the effectiveness of functional range conditioning in patients with chronic non-specific low back pain in terms of improving hip internal rotation and strength of the hip abductors, and reducing pain and disability.

详细描述

It will be a single blind two-arm randomized controlled trial. Saudi men and women aged between 25 - 45 years with a diagnosis of chronic non-specific low back pain will be invited to participate in this study. Subjects who will fulfill the study's criteria and who are willing to participate in this study will be asked to sign an informed consent form. The primary outcome will be the active and passive range of motion (ROM) of the hip internal rotators and it will be measured using digital inclinometer. The secondary outcomes in this study will be the maximum torque of the hip abductors (gluteus medius), concentric at a constant, low-speed, and high-speed. The peak torque and strength will be measured using isokinetic dynamometry, pain intensity will be assessed using a visual analog scale and disability will be assessed using Oswestry disability index. All participants will have their information taken by the principal investigator. Subsequently, participants will randomly be assigned to either the FRC group or the conventional treatment group by the principal investigator. Concealed randomization will be performed by means of a computer-generated table of random numbers. Outcomes will be measured at baseline, week 4 and week 8 for all participants in both groups by an assistant researcher.

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, Care Provider)

盲法说明

Outcome provider masked about the outcomes

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Saudi men and women aged between 25 - 45 years with a diagnosis of chronic non-specific low back pain

排除标准

  • Hip, spine and knee pathology.
  • Hip and knee replacement.
  • Surgery and fracture within the last 6 months.
  • Pregnant women.
  • Any medical condition that precluded safe participation in exercise programs such as significant cardiac, pulmonary, neurological disease or mental disorder.

研究组 & 干预措施

FRC group

Experimental

This group will receive FRC exercise.

干预措施: FRC exercise (Behavioral)

Conventional treatment

Experimental

This group will receive conventional exercise.

干预措施: Conventional Exercise (Behavioral)

结局指标

主要结局

Passive range of motion (Hip internal rotation)

时间窗: Change from baseline passive hip internal range of motion at 8 weeks

It will be measured using digital inclinometer

次要结局

  • Pain Intensitiy(Change from baseline pain intensity at 8 weeks)
  • Strength of the hip abductors (gluteus medius)(Change from baseline hip abductors strength at 8 weeks)
  • Functional disability(Change from baseline functional disability at 8 weeks)

研究者

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

Reem S. Alattallah

Post Graduate student, Principal Investigator

King Saud University

研究点 (1)

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