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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05687695
Other study ID # P.T.REC/012/003264
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 8, 2023
Est. completion date August 20, 2023

Study information

Verified date August 2023
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

evaluation of core muscles endurance and strength following backward walking training programe


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date August 20, 2023
Est. primary completion date August 20, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 30 Years
Eligibility 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: 1. LBP as a result of a specific spinal condition (e.g. spondylolisthesis, or spinal stenosis). 2. Previous abdominal or spinal surgery. 3. Serious spinal conditions (e.g., vertebral fracture, tumor or infection). 4. Severe musculoskeletal deformity (scoliosis or kyphosis). 5. Inflammatory disorders (e.g. Rheumatoid arthritis). 6. Radicular symptoms consistent with a disc herniation, or cauda equina syndrome. 7. Pain and dysfunction in the upper and lower extremity that would interfere with testing. 8. Current pregnancy. 9. Marked leg length discrepancy greater than 2 cm.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
backward walking program
six weeks of backward walking program at self selected speed for 30 minutes 3 times per week
core training
six weeks of core training program including curl up, lateral plank on both sides, bird dog exercises done 3 times per week

Locations

Country Name City State
Egypt Faculty of Physical Therapy Giza Dokki

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in trunk flexors, extensors and hip extensors, abductors muscles strength concentric peak torque of trunk flexors and extensors and hip extensors and abductors measured twice before and after 6 weeks of intervention
Primary Change in core muscles endurance core muscles endurance assessed by McGill endurance tests measured twice before and after 6 weeks of intervention
Secondary 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 measured twice before and after 6 weeks of intervention
Secondary 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%.
measured twice before and after 6 weeks of intervention
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