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临床试验/NCT04394494
NCT04394494已完成不适用

A Randomized Clinical Trial of Extension for Low Back Pain: Motor Imagery of Extension Versus Physical Extension Exercises

St. Ambrose University8 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年5月25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
10
试验地点
8
主要终点
Pain rating

研究概览

简要总结

Low back pain (LBP) is the most common musculoskeletal condition treated in physical therapy, accounting for an estimated 25-40% of outpatient physical therapy visits. One strategy commonly used for treating LBP is directional preference. Directional preference is the process of examining a patient with LBP's response to a movement direction, i.e., extension, and if it coincides with improvement, the test becomes part of the treatment. Various studies have shown evidence for, and use of directional preference by physical therapists. Specifically for LBP, directional preference usually involves either an extension-bias or flexion-bias, with various studies indication an extension protocol being the most common (estimated > 80% of patients). With extension exercises, a favorable therapeutic effect result in centralization of symptoms (leg pain migrates proximal), improved range of motion (ROM), decreased pain and decreased fear of movement.

In recent years there has been an increased interest in various pain neuroscience strategies to help people in pain, including LBP. It is well established that the physical body of a person is represented in the brain by a network of neurons, often referred to as a representation of that particular body part in the brain. This representation refers to the pattern of activity that is evoked when a particular body part is stimulated. The most famous area of the brain associated with representation is the primary somatosensory cortex (S1). These neuronal representations of body parts are dynamically maintained. It has been shown that patients with pain display different S1 representations than people with no pain. The interesting phenomenon associated with cortical restructuring is the fact that the body maps expand or contract, in essence increasing or decreasing the body map representation in the brain. Furthermore, these changes in shape and size of body maps seem to correlate to increased pain and disability. Various studies have shown that physical movement is associated with restoring the cortical maps, which in turn may be associated with a decreased pain experience.

In patients with high levels of pain, sensitization of the nervous system and fear of movement, physical movement itself may increase a pain experience. An added therapeutic ability to help restore these cortical maps is motor imagery (visualization). Various studies have shown that motor imagery activate the same areas of the brain as when actually physically moving, thus restoring the altered maps "without moving."

详细描述

  • Patient arrive to physical therapy with low back pain (physician referral or self-referral)

  • Patient complete standard clinic medical and insurance intake forms

  • Based on the intake forms, patients are screened by the physical therapists against the inclusion criteria and if met, asked to participate in the study

  • Upon agreement, a written consent is signed

  • Patients complete research intake forms:

  • Demographic information

  • Age

  • Gender

  • Duration of LBP

  • Location of LBP (body chart with grid allocation)

  • Pain rating (NPRS): Numeric Pain Rating Scale

  • Fear-Avoidance (Physical and Work Subscales) (FABQ)

  • Pain Catastrophization Scale (PCS)

  • Patients undergo a standard physical therapy interview

  • Patients undergo a standard physical therapy examination

  • Patients undergo a directional preference test to determine if they are potentially responsive to extension exercises

  • Once patients are shown to be responsive to extension, they are alternately allocated to receive motor imagery of extension exercises (experimental group; [EG]) or physical extension exercises (control group, [CG]).

  • Prior to the treatment lumbar extension ROM will be measured via a standardized procedure

  • Upon completion of the tests, patients will receive one of two allocated treatments

Following the treatment, patients will undergo repeat measures of:

  • Spinal extension ROM
  • Pain rating
  • Fear of movement
  • Pain catastrophization Patients will be asked to return to physical therapy in 2 to 3 days (standard care)

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

Patients will be assigned in an alternating order to either the experimental or control group.

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • LBP of less than 3 months duration
  • Age 18-65
  • Able to read and understand English
  • Fit directional preference of extension

排除标准

  • Any red flags for therapy
  • Prior spinal surgery
  • Directional preference of flexsion

结局指标

主要结局

Pain rating

时间窗: within a single, 90 minute session

Numeric pain rating Scale 0 - 10 (0 = no pain and 10 = worst pain). The minimal detectable change (MDC) for the NPRS for low back pain is reported to be 2.0.

Spine ROM

时间窗: within a single, 90 minute session

range patient is able to bend backward

Fear of Movement

时间窗: within a single, 90 minute session

Fear Avoidance Belief Questionnaire (FABQ): The FABQ is a self-report of patients feelings about their fear to move.

Pain Catastrophization

时间窗: within a single, 90 minute session

Pain Catastrophization Scale: The PCS is a self-report questionnaire assessing inappropriate coping strategies and catastrophic thinking about pain and injury. on a 13-item, 5-point Likert scale with higher scores indicating elevated levels of catastrophizing.

次要结局

未报告次要终点

研究者

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

Kevin Farrell

Professor and Chair, Orthopaedic Residency Program in Physical Therapy

St. Ambrose University

研究点 (8)

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