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临床试验/NCT04155450
NCT04155450已完成不适用

Effects of Extension Biased External Limb Loading in Addition to McKenzie Extension Protocol in Lumbar Derangement Syndrome

Foundation University Islamabad4 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年11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
30
试验地点
4
主要终点
Postural Stability Index PSI will be assessed at the base line and at the end of 2 weeks session.

研究概览

简要总结

Low back pain is one of the most common problem affecting one's daily living activities.

McKenzie Method of Mechanical Diagnostic Therapy (MDT) is an appealing modality of treatment. McKenzie classified the lumbar back pain into three categories i.e. lumbar postural syndrome, lumbar dysfunction syndrome and lumbar derangement syndrome.

Progressive extension bias limb loading exercises at lumbar region emphasizes on lumbar extensor musculature. The purpose of the current study is to determine the effects of extension biased lumbar limb loading exercises along with McKenzie extension protocols in the management of patients with lumbar derangement syndrome, which will also be a cost effective management option. It will also add to the existing pool of knowledge in the fields of conservative low back pain treatment, physical therapy, orthopedic manual therapy and musculoskeletal medicine.

详细描述

Low back pain is one of the most common problem affecting one's daily living activities.

Back pain results from multifactorial etiology with anatomical, psychological, physiological and social consequences and it is often classified as acute, sub-acute and chronic according to pain duration. Upto 71% of people with acute low back pain in primary care report persistent symptoms and therefore there is requirement for effective treatments in those who have not recovered after acute phase. Therapeutic exercises, manual therapy, functional training, modalities, traction, endurance training of back extensors, Kinesio-taping, trigger point therapy, deep friction massage are some of the procedures being safely and effectively applied by physical therapists to combat back discomfort or disorder.

McKenzie Method of Mechanical Diagnostic Therapy (MDT) approach was developed by Robin McKenzie who was a physical therapist from New Zealand back in 1950s. MDT is an appealing modality of treatment focusing on five areas of benefit-including reliable assessment, early prognosis, self-treatment, better outcomes and prevention of recurrence. The evaluation also determine who will get benefit from treatment and who will require another treatment protocols. McKenzie classified the lumbar back pain into three categories i.e. lumbar postural syndrome, lumbar dysfunction syndrome and lumbar derangement syndrome based on symptomatic or mechanical responses observed during repeated lumbar end range movements. The McKenzie Institute Lumbar Spine Assessment will be used to classify the patients into different syndromes and to choose the desired one fulfilling the inclusion criteria of study.

When normal tissues are deformed over a prolonged period it ends with postural syndrome like slouched posture and the postural syndrome may lead to dysfunction or derangement syndromes. Deformation of structures and tissues that causes pain at end ranges of available motion is characterized as dysfunction syndrome. Derangement syndrome is related to displacement of intervertebral disc with or without involvement of radiating pattern of pain along with back pain and fluctuations in symptoms or pain with directional movements can be observed due to force changes on affected intervertebral disc.

Centralizing and Peripherilizing are two important concepts with a strong association towards derangement syndrome. Centralizing reveals that movements or loading moves the most distal pain proximally while Peripherilizing shows movements or loading moves the pain more distally. McKenzie lumbar extension exercises results in reduction, abolition or centralization of symptoms. In Lumbar derangement syndromes following MDT classification system, a subgroup in which symptoms improve with lumbar extension is labeled as posterior derangement syndrome whereas the subgroup in which symptoms improve with lumbar flexion is labeled as anterior derangement syndrome. Work of many researchers, like Peterson, Machado and Paatelma, provided the strongest evidence regarding the validity of McKenzie method of treatment.

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
Single (Participant)

盲法说明

Participant is unaware of the treatment group he is in.

入排标准

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

入选标准

  • Patients of age 30 to 50 years
  • Patients of both Gender i.e. Male & Female
  • Lumbar Derangement Syndrome
  • Centralization or Peripheralization phenomenon
  • Constant or Intermittent pain worsening on repeated movements
  • Somatic, radicular or combination of both patterns of pain
  • Positive Radicular signs & symptoms

排除标准

  • Lumbar Postural syndrome
  • Lumbar Dysfunction syndrome
  • Post laminectomy/discectomy
  • Spondylolisthesis
  • Osteoporosis/Fractures
  • Cauda equine syndrome
  • Recent history of spinal trauma or surgery
  • Lumbar myelopathy
  • Patients with known metabolic diseases
  • Participants having less than 20% ODI scoring

结局指标

主要结局

Postural Stability Index PSI will be assessed at the base line and at the end of 2 weeks session.

时间窗: 2 weeks

Postural stability screening test will be used to determine the postural stability index of the participants.

Clinical Test of Sensory Integration of Balance

时间窗: 2 weeks

Clinical Test of Sensory Integration of Balance (CTSIB) will be assessed at the base line and at the end of 2 weeks session.

Balance Error Scoring System

时间窗: 2 weeks

Balance Error Scoring System (BESS) will be assessed at the base line and at the end of 2 weeks session.

Oswestry Disability Index

时间窗: 2 weeks

Oswestry Disability Index (ODI) assess symptoms and severity of low back pain in terms of disablement and the degree to which back pain impacts functional activities. Questionnaire has been designed to give us information as to how one's back or leg pain is affecting his/her ability to manage in everyday life. It has good person and item reliability with an excellent test retest reliability (ICC= 0.97) and floor effect of 29.9% and ceiling effect of 3.9%. ODI will be assessed at the base line and at the end of 2 weeks session. Lower score shows better outcome.

Fall Risk Test

时间窗: 2 weeks

Biodex Balance System has a fall risk screening test and conditioning protocol based on well-established science and technology. Screening include analytical balance testing by identifying a potential problem and establishes Z-Score on the basis of mean values. Fall risk will be assessed at the base line and at the end of 2 weeks session. Lower score shows better outcome.

STarT Back Screening Tool

时间窗: 2 weeks

The Keele STarT Back Screening Tool (SBST) (9-item version) is a brief validated tool, designed to screen primary care patients with low back pain for prognostic indicators that are relevant to initial decision making. STarT will be assessed at the base line and at the end of 2 weeks session.

Range of Motion

时间窗: 2 weeks

Lumbar ROM including Forward bending, Backward bending, Right side bending and Left side bending will be measured using Inclinometers. ROM will be assessed at the base line and at the end of 2 weeks session. Greater range shows better outcome.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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