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临床试验/NCT03565926
NCT03565926已完成不适用

Effects of Hipopressive Exercises Versus Manual Therapy in Subjects With Nonspecific Low Back Pain

University of Valencia2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2018年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
2
主要终点
Intensity of pain

研究概览

简要总结

Introduction Non-specific low back pain is very prevalent in our society. Different effective physiotherapy treatments have been performed in the reduction of pain and improvement of quality of life, however there are few studies that exist on the effectiveness of these treatments in protocol format based on manual therapy. On the other hand, there are no studies that implement a protocol of therapeutic exercises called abdominal hypopressives.

The aim of the study is to study the effect of a manual therapy protocol on non-specific low back pain and the implementation of hypopressive exercises in different areas such as disability, pain, flexibility and quality of life.

Material and methods

Participants The sample will consist of subjects with non-specific low back pain. Inclusion criteria

-Participants with nonspecific lumbar pain of at least 4 pain crises a month with recurrent low back pain.

Exclusion criteria

  • Light acute.
  • Lumbalgia after trauma.
  • Presenting sciatica or musculoskeletal disorders or injuries within three months prior to the study.
  • Contraindication of one of the two treatments.
  • Participate in this period of no functional recovery program or physiotherapy treatment.

Study design A randomized clinical trial will be conducted. The sample will be divided into 2 groups: Group 1 will receive a manual therapy protocol that has previously shown its effectiveness in non-specific low back pain being 1 session a week, while group 2 will receive a protocol of hypopressive therapeutic exercises.

Evaluations

At the beginning of the study, a clinical interview will be carried out and, in addition, 3 evaluations will be carried out: at the beginning, at the end of the treatment and one follow-up per month. The investigators will use the following evaluation tools:

  • Pain, through the Visual Analog Scale.
  • Oswestry Low Back Pain Disability Scale.
  • SF-36 quality of life scale.
  • Visual Analog Scale.
  • Algometry of spinous processes and lumbar muscles.
  • Lumbar flexion with inclinometer and fingers test - floor.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Man between 18 and 40 years old
  • Recurrent episodes of low back pain at least 4 times a month
  • At least 3 months of evolution
  • Non-specific low back pain
  • Not having undergone surgery

排除标准

  • Acute low back pain
  • Lumbalgia operated surgically
  • Low back pain after traumatism
  • Episodes of sciatica
  • Contraindication to any of the treatments
  • Attend, during the study period, rehabilitation programs
  • Serious injuries in the 3 months prior to the study
  • Root pain
  • Any breach of the inclusion criteria

结局指标

主要结局

Intensity of pain

时间窗: 8 weeks

Visual Analog Scale. The participants are asked to mark the intensity of pain from 1 to 10, with 1 being almost non-existent and 10 being the worst pain imaginable.

次要结局

  • Health status(8 weeks)
  • Algometry of spinous processes and lumbar muscles.(8 weeks)
  • Low Back Pain Disability(8 weeks)
  • Lumbar flexion(8 weeks)

研究者

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

GEMMA V ESPÍ LÓPEZ, PhD

Principal Investigator

University of Valencia

研究点 (2)

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