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

Primary Purpose

Chronic Low-back Pain

Status
Active
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Pain neuroscience education
Standard Therapy
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Foundation University College of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pain neuroscience education group

Standard therapy group

Arm Description

Pain neuroscience education 10- 15min Hot pack(10 min) TENS Kaltenborn Moilization technique at L4-L5 segment stretchings and stabilization exercises. (5 reps/1 set) Total duration:40 min/session

Hot pack(10 min) TENS Kaltenborn Mobilization technique at L4-L5 segment stretchings and stabilization exercises (5 reps /1 set) Total duration:30 min/session

Outcomes

Primary Outcome Measures

Pain intensity
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
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
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.

Secondary Outcome Measures

Full Information

First Posted
December 26, 2022
Last Updated
December 26, 2022
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT05680506
Brief Title
Effects of Pain Neuroscience Education With Conventional Physical Therapy in Patients With Chronic Low Back Pain
Official Title
Effects of Pain Neuroscience Education With Conventional Physical Therapy in Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a randomized controlled trial which will consist of two groups. One will recieve conventional physcial therapy only and the second will recieve conventional physcial therapy with pain neuroscience education.Both groups will be recruited concurrently.
Masking
Outcomes Assessor
Masking Description
The outcome assessor will be a another person who will be unaware of the group the particpant belong to
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pain neuroscience education group
Arm Type
Experimental
Arm Description
Pain neuroscience education 10- 15min Hot pack(10 min) TENS Kaltenborn Moilization technique at L4-L5 segment stretchings and stabilization exercises. (5 reps/1 set) Total duration:40 min/session
Arm Title
Standard therapy group
Arm Type
Active Comparator
Arm Description
Hot pack(10 min) TENS Kaltenborn Mobilization technique at L4-L5 segment stretchings and stabilization exercises (5 reps /1 set) Total duration:30 min/session
Intervention Type
Procedure
Intervention Name(s)
Pain neuroscience education
Intervention Description
Pain neuroscience education will be given in form videos,pictures, stories and metaphors for 2 times per week for 4 weeks.
Intervention Type
Procedure
Intervention Name(s)
Standard Therapy
Intervention Description
Hot pack,TENS, Kaltenborn grade 1 and 2 mobilizations, stretchings and lumbar stabilization exercises
Primary Outcome Measure Information:
Title
Pain intensity
Description
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
Time Frame
4 weeks
Title
Disability
Description
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).
Time Frame
4 weeks
Title
Kinesiophobia
Description
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.
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both male and female of age 40-65 years Patients with chronic primary low back pain (medium risk patients on Start Back Screening Tool) Exclusion Criteria: 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
Facility Information:
Facility Name
Foundation University College of Physical Therapy
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

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

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