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A Suggested Functional Exercises Program For Patients With Chronic Mechanical Low Back Pain

Primary Purpose

Chronic Mechanical Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
advices
exercises plus advices
Sponsored by
Doha Ali Amin Ahmed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Mechanical Low Back Pain

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Chronic mechanical low back pain and their age will be ranged from 20 -45 years. History of chronic low back pain (≥3 months). Patients with Body Mass Index (BMI) between 18-28 Exclusion Criteria: Age younger than 20 or older than 45 years of age. History of any surgical procedure in the back or the lower extremities Back pain secondary to known specific pathology (e.g. infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis) or cauda equine syndrome). Patient with lumbar instability including spondylolisthesis. Red flags (e.g. fever, unexplained weight loss, progressive weakness, radiation to lower limb, bowel and bladder dysfunction). Pregnancy.

Sites / Locations

  • Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

advices

exercises plus advices

Arm Description

• Group I (control) will receive advices only.

• Group II (experimental) will receive a suggested functional exercise program plus advises

Outcomes

Primary Outcome Measures

pain in lower back
will be measured by The Numeric Pain Rating Scale (NPRS). it consists of The 11-point numeric scale ranges from '0' representing one pain extreme (e.g., "no pain") to '10' representing the other pain extreme (e.g., "pain as bad as you can imagine" or "worst pain imaginable .patients are asked to indicate the point along the line that best reflect their pain intensity .
functional disability
will be measured by Arabic version of Oswestry Disability Index (ODI) is a self-reported questionnaire consisting of 10 questions related to back function . Each question is answered on a 6-item Likert scale and is scored from 0 (minimum degree of difficulty in that activity) to 5 (maximum degree of difficulty). These questions assess the activities of daily living in patients with LBP. The questions in the index include pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. The validity of Arabic version of ODI is good intra-observer reliability was excellent . The correlations of the ODI with the VAS pain scale, the Roland-Morris Low Back Pain Disability and the Quebec Back Pain Disability.
core muscles stability
The researcher will conduct a series of core stability tests before and after the core training program. Core stability tests has been reported to be highly reliable (ICC ≥ 0.98) and showed moderate to high correlation with one another (correation coefficient ranged from 0.4 to 0.8) , The following core tests will be used: trunk flexion test (McGill's test) , Trunk extension (Sorenson Test) , Side plank test and prone plank test .
lower limb function
will measured by Functional assessment using one legged hops test The most commonly used functional tests are a series of one-legged hops described by Noyes et al. (1991). The sensitivity of the single (49%), triple (50%), crossover (58%), and timed (52%) hop tests were reported by Noyes et al. (1991). The specificity was 97% and 94% for the timed and single hops, respectively

Secondary Outcome Measures

Full Information

First Posted
April 24, 2023
Last Updated
May 7, 2023
Sponsor
Doha Ali Amin Ahmed
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05860218
Brief Title
A Suggested Functional Exercises Program For Patients With Chronic Mechanical Low Back Pain
Official Title
A Suggested Functional Exercises Program For Patients With Chronic Mechanical Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Doha Ali Amin Ahmed
Collaborators
Cairo University

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
The aim of this study will be to investigate the effect of functional exercise on pain, functional disability and core strength in patients with chronic mechanical low back pain .
Detailed Description
To our knowledge, there has been not enough studies that investigated the effect of core strengthening by functional exercise on pain, functional disability and core muscle strength in patients with chronic mechanical low back pain. Therefore, this study may open up ways to other researchers to investigate and build up on this effect if present and address such an important issue. the finding of this proposed work may help patients with chronic mechanical low back pain by addressing their pain, functional limitation, and/or participation restrictions. Consequently, this can speed up their recovery, return to work, decrease cost of treatment, improve psychological status, decrease level of irritability, and improve overall quality of life. Patients with chronic mechanical low back pain will be recruited after approval of ethical committee of the faculty of physical therapy, Cairo University. All participants will sign a written informed consent form. The subjects will be randomly assigned into one of two groups: Group I (control) will receive advices only. Group II (experimental) will receive a suggested functional exercise program plus advises. the measurments will take before and after treatment programe .

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
advices
Arm Type
Other
Arm Description
• Group I (control) will receive advices only.
Arm Title
exercises plus advices
Arm Type
Experimental
Arm Description
• Group II (experimental) will receive a suggested functional exercise program plus advises
Intervention Type
Other
Intervention Name(s)
advices
Intervention Description
The following advice will be given to the patients : Walking as flexibly (normally) as possible Advise when lifting ; avoid twisting and bending. for heavy objects use thighs with a vertical back. at other times, use the back and flex it. Heat application for 20 mins twice /day . Avoid sitting or standing for prolonged period and change position every 15 mins. Sitting: Sit with a back support Driving: Use a back support (lumbar roll) at the curve of your back. Sleeping and lying down: Select a firm mattress and box spring set that does not sag. If necessary, place a board under your mattress. You can also place the mattress on the floor temporarily if necessary.
Intervention Type
Other
Intervention Name(s)
exercises plus advices
Other Intervention Name(s)
a suggested functional exercise program plus advises.
Intervention Description
In addition to the same advice of group A, a suggested functional exercise will be performed for this group. Sidestepping against band resistance: The quadriped opposite arm leg aganist resistance . Squat row on a balance board with band resistance: Front raise single leg support with band resistance: The Advanced Prone Bridge: Side sliding on a fitter board (lateral lunge with band):
Primary Outcome Measure Information:
Title
pain in lower back
Description
will be measured by The Numeric Pain Rating Scale (NPRS). it consists of The 11-point numeric scale ranges from '0' representing one pain extreme (e.g., "no pain") to '10' representing the other pain extreme (e.g., "pain as bad as you can imagine" or "worst pain imaginable .patients are asked to indicate the point along the line that best reflect their pain intensity .
Time Frame
change from max pain point in 1 month
Title
functional disability
Description
will be measured by Arabic version of Oswestry Disability Index (ODI) is a self-reported questionnaire consisting of 10 questions related to back function . Each question is answered on a 6-item Likert scale and is scored from 0 (minimum degree of difficulty in that activity) to 5 (maximum degree of difficulty). These questions assess the activities of daily living in patients with LBP. The questions in the index include pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. The validity of Arabic version of ODI is good intra-observer reliability was excellent . The correlations of the ODI with the VAS pain scale, the Roland-Morris Low Back Pain Disability and the Quebec Back Pain Disability.
Time Frame
change in 1 month
Title
core muscles stability
Description
The researcher will conduct a series of core stability tests before and after the core training program. Core stability tests has been reported to be highly reliable (ICC ≥ 0.98) and showed moderate to high correlation with one another (correation coefficient ranged from 0.4 to 0.8) , The following core tests will be used: trunk flexion test (McGill's test) , Trunk extension (Sorenson Test) , Side plank test and prone plank test .
Time Frame
change in 1 month
Title
lower limb function
Description
will measured by Functional assessment using one legged hops test The most commonly used functional tests are a series of one-legged hops described by Noyes et al. (1991). The sensitivity of the single (49%), triple (50%), crossover (58%), and timed (52%) hop tests were reported by Noyes et al. (1991). The specificity was 97% and 94% for the timed and single hops, respectively
Time Frame
change in 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic mechanical low back pain and their age will be ranged from 20 -45 years. History of chronic low back pain (≥3 months). Patients with Body Mass Index (BMI) between 18-28 Exclusion Criteria: Age younger than 20 or older than 45 years of age. History of any surgical procedure in the back or the lower extremities Back pain secondary to known specific pathology (e.g. infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis) or cauda equine syndrome). Patient with lumbar instability including spondylolisthesis. Red flags (e.g. fever, unexplained weight loss, progressive weakness, radiation to lower limb, bowel and bladder dysfunction). Pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Doha Ali, master
Phone
01019734952
Email
prinessoflight@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Ahmed, Lecturer
Phone
01223631604
Facility Information:
Facility Name
Cairo university
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doha Ali, master
Phone
01019734952
Email
prinessoflight@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohamed Ahmed, Lecturer
Phone
01223631604

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
undecided

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A Suggested Functional Exercises Program For Patients With Chronic Mechanical Low Back Pain

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