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Effects of Therapeutic Neuroscience Education in Patients With Chronic Low Back Pain

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
TNE
core stability
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring back pain, therapuetic neuroscience education, range of motion

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diffused chronic low back pain Stop movement due to fear of increasing pain Anxiety and sleep problem with CLBP Symptoms duration most of days in 6 months No treatment other than analgesics Exclusion Criteria: Diabetes mellites Radiating pain Spine surgery, fracture, arthritis

Sites / Locations

  • District Headquarter Hospital Layyah

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TNE with core stability

Core stability

Arm Description

Group A (TNE WITH CORE STABILITY) on low back this McGill exercise focuses on the ability of the spine to stabilize in different positions 3 sets of 3 repletion with of each of muscle and briefly explain the patient about their pain.The study participants will receive the total 18 session over 6 weeks period consider 3 treatment session per week

McGill exercises for the low back. involved 3 sets of 3 repetitions for each muscle with a 30-second hold and 30-second rest interval for each repetition. The researcher will reassess the patient. Post treatment patient will complete Numeric Pain Rating Scale (NPRs), range of motion (Goniometer and Oswestry disability index (ODI). All study participant will receive a total of 18 treatment sessions over a six-week period, which consisted of 03 treatment sessions per week.

Outcomes

Primary Outcome Measures

Numeric pain rating scale for pain
NPRS (numeric pain rating scale) NPRS is based on 11 points numerical rating scale for determining pain intensity, 0( no ;pain), 10 (worst pain imaginable) pain intensity
Modified Oswestry Disability index (Disability and function)
Modified Oswestry Disability index Urdu version of Modified Oswestry Disability Index has become one of the principal condition-specific outcome measures used in the management of spinal disorders. At the baseline assessment, following each exercise session during the 12-week intervention, and finally at the end of the intervention programme, the MODI scores will be recorded

Secondary Outcome Measures

Goniometer (Range of Motion)
A goniometer is an instrument that measures the available range of motion at a joint. The art and science of measuring the joint ranges in each plane of the joint are called goniometry. To measure the range of motion physical therapists most commonly use a goniometer.

Full Information

First Posted
April 18, 2023
Last Updated
September 22, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05848076
Brief Title
Effects of Therapeutic Neuroscience Education in Patients With Chronic Low Back Pain
Official Title
Effects of Therapeutic Neuroscience Education on Nociplastic Pain and Disability in Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

Brief Summary
The study will be Randomized controlled trail, Subject diagnosed with low back pain meeting predetermined inclusion and exclusion criteria will be divided into two groups. Pre assessment will be done using pain and disability as subjective measurement through Numeric pain rating scale (NPRS) & modified Oswestry disability index and the lumber range by goniometer as objective measurement. One group is subject will be treated with therapeutic neuroscience education and core stability exercise and second group is core stability exercise. Each subject received 18 sessions with 3 treatments per week. Post treatment values recorded after the session.After data collection from defined study setting,data will be entered and analyzed at Riphah International University,Lahore
Detailed Description
Chronic low back pain (LBP) is very common musculoskeletal disorders and leading causes of disability worldwide. Numerous epidemiological data show that 11%-84% of people experience, have experienced,or will experience pain in the lower spine at least once in their lives . With a global prevalence of 9.4%, LBP was ranked highest in the number of years lived with a disability and sixth in overall burden of disease Pakistan can suffer 56% from the LBP Nociplastic pain can be mechanistically defined as pain arising from the altered function of pain-related sensory pathways in the periphery and CNS, causing increased sensitivity Nociplastic pain should be viewed as an overarching terminology that can be applied to a diverse range of clinical conditions that share common neurophysiological mechanisms. The main concern of TNE concept is that increasing the patient feeling of biology and physiology underpinning their pain condition instead of focus on anatomy and structure issues of tissue.In order to improve health of patient with CLBP healthcare provider proper educate their patient about experiencing pain and it may not result of tissue damage Several non surgical treatments have been offered to help and decrease LBP, such as joint manipulation, traditional therapeutic exercises , and medication core stability training (CST) program this type of exercise focuses on the ability of the spine to stabilize in different positions and emphasize smaller, deeper, and posterior muscles. By increasing the endurance of these muscles, they retrain and maintain the correct physical condition to stabilize the spine to improve pain, performance, and ROM There are few studies in literature which compare the TNE effect with core stability exercisein CLBP however there have been no studies which can compare TNE with nociplastic pain which effects on CLBP

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain
Keywords
back pain, therapuetic neuroscience education, range of motion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
blinding
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TNE with core stability
Arm Type
Experimental
Arm Description
Group A (TNE WITH CORE STABILITY) on low back this McGill exercise focuses on the ability of the spine to stabilize in different positions 3 sets of 3 repletion with of each of muscle and briefly explain the patient about their pain.The study participants will receive the total 18 session over 6 weeks period consider 3 treatment session per week
Arm Title
Core stability
Arm Type
Active Comparator
Arm Description
McGill exercises for the low back. involved 3 sets of 3 repetitions for each muscle with a 30-second hold and 30-second rest interval for each repetition. The researcher will reassess the patient. Post treatment patient will complete Numeric Pain Rating Scale (NPRs), range of motion (Goniometer and Oswestry disability index (ODI). All study participant will receive a total of 18 treatment sessions over a six-week period, which consisted of 03 treatment sessions per week.
Intervention Type
Other
Intervention Name(s)
TNE
Intervention Description
McGill exercise focuses on the ability of the spine to stabilize in different positions 3 sets of 3 repletion with of each of muscle and briefly explains the patient about their pain
Intervention Type
Other
Intervention Name(s)
core stability
Intervention Description
McGill exercises for the low back.
Primary Outcome Measure Information:
Title
Numeric pain rating scale for pain
Description
NPRS (numeric pain rating scale) NPRS is based on 11 points numerical rating scale for determining pain intensity, 0( no ;pain), 10 (worst pain imaginable) pain intensity
Time Frame
3 weeks
Title
Modified Oswestry Disability index (Disability and function)
Description
Modified Oswestry Disability index Urdu version of Modified Oswestry Disability Index has become one of the principal condition-specific outcome measures used in the management of spinal disorders. At the baseline assessment, following each exercise session during the 12-week intervention, and finally at the end of the intervention programme, the MODI scores will be recorded
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Goniometer (Range of Motion)
Description
A goniometer is an instrument that measures the available range of motion at a joint. The art and science of measuring the joint ranges in each plane of the joint are called goniometry. To measure the range of motion physical therapists most commonly use a goniometer.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diffused chronic low back pain Stop movement due to fear of increasing pain Anxiety and sleep problem with CLBP Symptoms duration most of days in 6 months No treatment other than analgesics Exclusion Criteria: Diabetes mellites Radiating pain Spine surgery, fracture, arthritis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Sanaullah, MS
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ume Habiba
Organizational Affiliation
Study Principle Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
District Headquarter Hospital Layyah
City
Layyah
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Therapeutic Neuroscience Education in Patients With Chronic Low Back Pain

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