Non-specific Low Back PainNCT05687695
Core Muscle Response to Backward Walking in Patients With Non Specific Low Back Pain
A study testing backward walking program and core training in people with Non-specific Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
evaluation of core muscles endurance and strength following backward walking training programe Read more about this study
- Who is it for?
- Ages 18 to 30 years, women only
- Conditions the study is for
- Non-specific Low Back Pain
- What is being tested?
- backward walking program and core training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jan 2023to 20 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
evaluation of core muscles endurance and strength following backward walking training programe
Read the 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.
- Conditions
- Non-specific Low Back Pain
- Being tested
- backward walking program, core training
- Keywords
- NSLBP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
backward walking programOther
six weeks of backward walking program at self selected speed for 30 minutes 3 times per week
core trainingOther
six weeks of core training program including curl up, lateral plank on both sides, bird dog exercises done 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| backward walking training group | Experimental | six weeks of backward walking training program 3 times per week Receives: Other: backward walking program |
| core training group | Active comparator | six weeks of core training 3 times per week Receives: Other: core training |
| control group | No intervention | patients will not receive any intervention for six weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: measured twice before and after 6 weeks of intervention
Change in core muscles endurance
core muscles endurance assessed by McGill endurance tests
Measured: measured twice before and after 6 weeks of intervention
Secondary outcomes (2)
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: measured twice before and after 6 weeks of intervention
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: measured twice before and after 6 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start8 Jan 2023
- Primary completion20 Aug 2023
- Study completion20 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-specific Low Back PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Amr Ahmed Mohammed, Cairo University
- Investigators
- Salam M Elhafez, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687695
- Sponsor's protocol ID
- P.T.REC/012/003264
- Status last verified
- Aug 2023
- First submitted
- 22 Dec 2022
- Last updated
- 30 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Core Muscle Response to Backward Walking in Patients With Non Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT05687695
- Acronym / sponsor ID
- P.T.REC/012/003264
- Conditions
- Non-specific Low Back Pain
- Keywords
- NSLBP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 8 Jan 2023 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 20 Aug 2023 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| backward walking training group | Experimental | Other: backward walking programsix weeks of backward walking training program 3 times per week |
| core training group | Active comparator | Other: core trainingsix weeks of core training 3 times per week |
| control group | No intervention | –patients will not receive any intervention for six weeks |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- Participants will be excluded if they have:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| backward walking programsix weeks of backward walking program at self selected speed for 30 minutes 3 times per week | Other | backward walking training group |
| core trainingsix weeks of core training program including curl up, lateral plank on both sides, bird dog exercises done 3 times per week | Other | core training group |
Primary outcome
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
Change in core muscles endurance
Time frame: measured twice before and after 6 weeks of intervention
core muscles endurance assessed by McGill endurance tests
2 secondary outcomes
Change in pain severity assessed by visual analogue scale
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salam M Elhafez, Professor study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing backward walking program and core training in people with Non-specific Low Back Pain, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in trunk flexors, extensors and hip extensors, abductors muscles strength (time frame: measured twice before and after 6 weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2023.