- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05687695
Core Muscle Response to Backward Walking in Patients With Non Specific Low Back Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Dokki
-
Giza, Dokki, Egypt, 12613
- Faculty of Physical Therapy
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: backward walking training group
six weeks of backward walking training program 3 times per week
|
six weeks of backward walking program at self selected speed for 30 minutes 3 times per week
|
|
Active Comparator: core training group
six weeks of core training 3 times per week
|
six weeks of core training program including curl up, lateral plank on both sides, bird dog exercises done 3 times per week
|
|
No Intervention: control group
patients will not receive any intervention for six weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in trunk flexors, extensors and hip extensors, abductors muscles strength
Time Frame: measured twice before and after 6 weeks of intervention
|
concentric peak torque of trunk flexors and extensors and hip extensors and abductors
|
measured twice before and after 6 weeks of intervention
|
|
Change in core muscles endurance
Time Frame: measured twice before and after 6 weeks of intervention
|
core muscles endurance assessed by McGill endurance tests
|
measured twice before and after 6 weeks of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in pain severity assessed by visual analogue scale
Time Frame: measured twice before and after 6 weeks of intervention
|
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
|
measured twice before and after 6 weeks of intervention
|
|
Change in pain related disability and quality of life
Time Frame: measured twice before and after 6 weeks of intervention
|
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%. |
measured twice before and after 6 weeks of intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: salam M Elhafez, Professor, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003264
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.