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Core Muscle Response to Backward Walking in Patients With Non Specific Low Back Pain

Primary Purpose

Non-specific Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
backward walking program
core training
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-specific Low Back Pain focused on measuring NSLBP

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Participants will be included if they have a history of LBP for more than 6 weeks before the study, or experienced at least 3 episodes of LBP each lasting more than one week, during the year before the study. Exclusion Criteria: Participants will be excluded if they have: LBP as a result of a specific spinal condition (e.g. spondylolisthesis, or spinal stenosis). Previous abdominal or spinal surgery. Serious spinal conditions (e.g., vertebral fracture, tumor or infection). Severe musculoskeletal deformity (scoliosis or kyphosis). Inflammatory disorders (e.g. Rheumatoid arthritis). Radicular symptoms consistent with a disc herniation, or cauda equina syndrome. Pain and dysfunction in the upper and lower extremity that would interfere with testing. Current pregnancy. Marked leg length discrepancy greater than 2 cm.

Sites / Locations

  • Faculty of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

backward walking training group

core training group

control group

Arm Description

six weeks of backward walking training program 3 times per week

six weeks of core training 3 times per week

patients will not receive any intervention for six weeks

Outcomes

Primary Outcome Measures

Change in trunk flexors, extensors and hip extensors, abductors muscles strength
concentric peak torque of trunk flexors and extensors and hip extensors and abductors
Change in core muscles endurance
core muscles endurance assessed by McGill endurance tests

Secondary Outcome Measures

Change in pain severity assessed by visual analogue scale
The Visual Analogue Scale will be used for measuring the pain intensity. It consists of a line, 10 cm long, whose ends are labeled as; no pain and very extreme pain. The line is marked for each 1 cm without any label. Patients are simply asked to indicate which point along the line that best represents their pain intensity. The distance from the "no pain" end to the mark made by the patient will be measured as the patient pain intensity score. VAS is a valid and reliable tool for pain measurement
Change in pain related disability and quality of life
The Oswestry Disability Index 10 criteria will be used to assess the degree of functional impairment includes pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (if applicable), social life, and travelling. The ODI scores is expressed in percentages and ranges from 0 (minimum disability) to 100 % (maximum disability). For each section the total possible score is 5: if the first statement is marked the section score= 0; if the last statement is marked, it= 5. For example, if all 10 sections are completed the score is calculated as follows: 16 (total scored) ÷ 50 (total possible score) x 100 = 32%. If one section is missed or not applicable the score is calculated as follows: 16 (total scored) ÷ 45 (total possible score) x 100 = 35.5%.

Full Information

First Posted
December 22, 2022
Last Updated
August 28, 2023
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05687695
Brief Title
Core Muscle Response to Backward Walking in Patients With Non Specific Low Back Pain
Official Title
Core Muscle Response to Backward Walking in Patients With Non Specific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 8, 2023 (Actual)
Primary Completion Date
August 20, 2023 (Actual)
Study Completion Date
August 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo 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
evaluation of core muscles endurance and strength following backward walking training programe
Detailed Description
A randomized controlled trial will be conducted at the Isokinetic laboratory, Faculty of Physical Therapy, Cairo University, to investigate the effect of backward walking training on core muscles strength and endurance, pain severity, and disability level in subjects with NSLBP. Sixty females clinically diagnosed with nonspecific low back pain with age range from 18-45 years will participate in the study. They will be randomly assigned into 3 groups according to the received intervention; backward walking group (BWG), core stability group (CSG), and control group (CG). The isokinetic strength of trunk muscles, and hip extensors and abductors will be evaluated in a concentric mode of muscle contraction. McGill's core endurance tests will be used to examine participants' core endurance. The visual analog scale will be used for measuring the pain intensity. The oswestry disability index will be used to assess pain related disability and quality of life in subjects with LBP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Low Back Pain
Keywords
NSLBP

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
backward walking training group
Arm Type
Experimental
Arm Description
six weeks of backward walking training program 3 times per week
Arm Title
core training group
Arm Type
Active Comparator
Arm Description
six weeks of core training 3 times per week
Arm Title
control group
Arm Type
No Intervention
Arm Description
patients will not receive any intervention for six weeks
Intervention Type
Other
Intervention Name(s)
backward walking program
Intervention Description
six weeks of backward walking program at self selected speed for 30 minutes 3 times per week
Intervention Type
Other
Intervention Name(s)
core training
Intervention Description
six weeks of core training program including curl up, lateral plank on both sides, bird dog exercises done 3 times per week
Primary Outcome Measure Information:
Title
Change in trunk flexors, extensors and hip extensors, abductors muscles strength
Description
concentric peak torque of trunk flexors and extensors and hip extensors and abductors
Time Frame
measured twice before and after 6 weeks of intervention
Title
Change in core muscles endurance
Description
core muscles endurance assessed by McGill endurance tests
Time Frame
measured twice before and after 6 weeks of intervention
Secondary Outcome Measure Information:
Title
Change in pain severity assessed by visual analogue scale
Description
The Visual Analogue Scale will be used for measuring the pain intensity. It consists of a line, 10 cm long, whose ends are labeled as; no pain and very extreme pain. The line is marked for each 1 cm without any label. Patients are simply asked to indicate which point along the line that best represents their pain intensity. The distance from the "no pain" end to the mark made by the patient will be measured as the patient pain intensity score. VAS is a valid and reliable tool for pain measurement
Time Frame
measured twice before and after 6 weeks of intervention
Title
Change in pain related disability and quality of life
Description
The Oswestry Disability Index 10 criteria will be used to assess the degree of functional impairment includes pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life (if applicable), social life, and travelling. The ODI scores is expressed in percentages and ranges from 0 (minimum disability) to 100 % (maximum disability). For each section the total possible score is 5: if the first statement is marked the section score= 0; if the last statement is marked, it= 5. For example, if all 10 sections are completed the score is calculated as follows: 16 (total scored) ÷ 50 (total possible score) x 100 = 32%. If one section is missed or not applicable the score is calculated as follows: 16 (total scored) ÷ 45 (total possible score) x 100 = 35.5%.
Time Frame
measured twice before and after 6 weeks of intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
there is gender related difference in the incidence of low back pain
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants will be included if they have a history of LBP for more than 6 weeks before the study, or experienced at least 3 episodes of LBP each lasting more than one week, during the year before the study. Exclusion Criteria: Participants will be excluded if they have: LBP as a result of a specific spinal condition (e.g. spondylolisthesis, or spinal stenosis). Previous abdominal or spinal surgery. Serious spinal conditions (e.g., vertebral fracture, tumor or infection). Severe musculoskeletal deformity (scoliosis or kyphosis). Inflammatory disorders (e.g. Rheumatoid arthritis). Radicular symptoms consistent with a disc herniation, or cauda equina syndrome. Pain and dysfunction in the upper and lower extremity that would interfere with testing. Current pregnancy. Marked leg length discrepancy greater than 2 cm.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Salam M Elhafez, Professor
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Physical Therapy
City
Giza
State/Province
Dokki
ZIP/Postal Code
12613
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Core Muscle Response to Backward Walking in Patients With Non Specific Low Back Pain

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