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临床试验/NCT05680506
NCT05680506进行中(未招募)不适用

Effects of Pain Neuroscience Education With Conventional Physical Therapy in Patients With Chronic Low Back Pain

Foundation University Islamabad2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
20
试验地点
2
主要终点
Pain intensity

研究概览

简要总结

Low back pain is currently considered to be the most common cause of disability.When low back pain occurs sensitivity of body increases which decreases overall body activity.Physical inactivity negatively effects recovery from chronic low back pain.Patients with chronic low back pain experience psychological anxiety and depression which leads to fear of pain and movement.There are various treatment options for chronic low back pain.But most treatment options deal with biomedical aspect of disease.Pain neuroscience education deals with psychological aspect of disease.By combining both treatment options we will be able to evaluate the combined biopsychosocial aspect of treatment.This study will mainly focus on the education of patients regarding neuroscience be hind their chronic low back pain.

详细描述

Low back pain is currently considered to be the most common cause of disability.This is the single greatest cause of years lived with disability.When low back pain occurs the sensitivity of body increases which decreases overall body activity.Physical inactivity negatively effects recovery from chronic low back pain.Patients with chronic low back pain experience psychological anxiety and depression which leads to fear of pain and movement. There are various treatmet options for chronic low back pain.But most treatment options deal with biomedical aspect of disease.Pain neuroscience education deals with psychological aspect of disease.By combining both treatment options we will be able to evaluate the combined biopsychosocial aspect of treatment.This study will mainly focus on education of patients regarding neuroscience behind their chronic low back pain.

A randomized control trial will be conducted in Tariq Memorial Neuro Clinic Islambad using non-probability purposive sampling.Participants will be briefed regarding the study objectives, procedure, risks and benefits of treament, voluntary participation and right to withdraw.Written informed consent will be taken from all the participants before conducting the research.Details of exercise program will be explained to them.Patients wiith chronic low back pain will be reffered by neuro-physician.Screening will be done by using Keel Start Back screening tool.Then the selected participants will be randomized into 2 groups(experimental group and control group)via sealed envelope method. Participants will complete Numeric Rating Pain Scale(NRPS) for pain, Roland Morris Disability Questionnaire for disability measurement and Tampa Scale for kinesiophobia.All of these measurements will be taken at baseline and then after 4 weeks of intervention.

The treatment protocol of both groups is as follows:

Group 1(Control group):hot pack, TENS for 15 mins, mobilization at L4-L5 segment, stretchings and stabilization exercises (5 reps/1set) Group 2(Experimental group):Pain neuroscience education for 15 mins, hot pack, TENS,mobilization at L4-L5 segment, stretchings and stabilization exercises.(5 reps/1 set)

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 (Outcomes Assessor)

盲法说明

The outcome assessor will be a another person who will be unaware of the group the particpant belong to

入排标准

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

入选标准

  • Both male and female of age 40-65 years
  • Patients with chronic primary low back pain (medium risk patients on Start Back Screening Tool)

排除标准

  • patients with motor and sensory dysfunction
  • patients with neurological abnormalities and muscle paalysis
  • patients with dizziness and uncontrolled hypertension
  • patients who could not take the basic posture of lumbar stabilization exercises because of pain

结局指标

主要结局

Pain intensity

时间窗: 4 weeks

Pain intensity will be measured on numeric rating pain scale. It consists of 11 points( interval 0-10), where 0 corresponds to no pain and 10 corresponds to worst pain imaginable. A graphical representation of 11 spaces is used for patients own evaluation of his or her pain

Disability

时间窗: 4 weeks

The activity disorder index is assessed using the Roland Morris Disability Questionnaire RMDQ. It consists of 0-24 point scale. The score ranges from 0 (no disability) to 24 (maximum disability).

Kinesiophobia

时间窗: 4 weeks

Tampa scale is used in patients with chronic musculoskeletal pain.It composed of 17 items scoring range from 1-4: (1) strongly disagree, (2) disagree, (3) agree,(4) strongly agree. For items 4,8,12 and 6 its vice versa.The total score of scale range from 17-68, where 17 means no kinesiophobia, 68 means severe kinesiophobia and 37 means there is kinesiophobia.

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 (2)

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