FlexibilityNCT04082013
Effect of Opposite Leg Position on Hamstring Flexibility in Patients With Mechanical Low Back Pain
An observational study of Flexibility, run by Cairo University at 1 site in Egypt.
Trial summary
PURPOSE: this study aimed to investigate the effect of opposite knee position on hamstring flexibility BACKGROUND Hamstrings tightness is one of the most common findings in patients with LBP. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Flexibility
- What is being tested?
- Hamstring Flexibility
- How many people
- 73 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 25 Jul 2019
- Phase
- Observational
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: * Male and female * Age range from 18-40 years old * With previous mentioned inclusion criteria
Who may be able to join
- Patients with history of back pain and assessed with Mechanical inflammatory low back pain index and have very high grade for mechanical component.
- Age ranges from 18-40 years.
- The body mass index of the subject is ≤25 kg/meter square.
Who cannot join
- Previous trauma, fractures or surgery of the back.
- Malignancy of the back.
- Rheumatoid arthritis
- Spondylolysis or spondylolithesis
- History of lower extremity injury within 6 months prior to the study
Trial locations and contacts
1 site in 1 country.
About this study
PURPOSE: this study aimed to investigate the effect of opposite knee position on hamstring flexibility BACKGROUND Hamstrings tightness is one of the most common findings in patients with LBP. It is thought that, due to the attachments of hamstrings to the ischial tuberosity, hamstrings tightness generates posterior pelvic tilt and decreases lumbar lordosis, which can result in LBP.
HYPOTHESES There will be significant difference in the hamstring flexibility with changing position of opposite knee (flexed or extended) in patients with mechanical low back pain.
RESEARCH QUESTION: Will changing position of opposite knee (flexed or extended) affect the hamstring flexibility in patients with mechanical low back pain?
Read the detailed description
- The subject will be instructed to maintain 90° hip flexion in the supine position.
- Then asked to actively extend the knee joint.
- The degree of achieving active knee extension will be measured using a universal goniometer.
- The average of three active knee extension measurements will be recorded used as the hamstring muscle length for the data analysis (Dong-Kyu Lee, et al., 2018).
- This test will be done for the same limb with opposite leg extended and with opposite flexed.
- Conditions
- Flexibility
- Being tested
- Hamstring Flexibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hamstring FlexibilityOther
The active knee extension test has been proposed as the gold standard for assessment of hamstring flexibility, as it utilizes readily available equipment and offers a quick, reliable, and low-cost alternative for measurement of hamstring flexibility (Connor et al; 2015).
- The subject will be instructed to maintain 90° hip flexion in the supine position.
- Then asked to actively extend the knee joint.
- The degree of achieving active knee extension will be measured using a universal goniometer.
- The average of three active knee extension measurements will be used as the hamstring muscle length for the data analysis (Dong-Kyu Lee, et al; 2018).
- the procedures will be done with opposite-leg flexed, then repeated with opposite-leg extended.
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee extension ROM
measuring knee extension ROM from 90 degrees hip flexion with opposite-leg flexed and extended
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start1 Apr 2019
- Primary completion27 Jun 2019
- Study completion25 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FlexibilityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nasr Awad Abdelkader Othman, Cairo University
- Investigators
- Nasr A. Abdelkader, PhD, Principal investigator, Lecturer,Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082013
- Sponsor's protocol ID
- P.T.REC/012/002301
- Status last verified
- Mar 2019
- First submitted
- 5 Sep 2019
- Last updated
- 29 Jul 2021
- 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 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Opposite Leg Position on Hamstring Flexibility in Patients With Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT04082013
- Acronym / sponsor ID
- P.T.REC/012/002301
- Conditions
- Flexibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 25 Jul 2019 (actual)
- First posted
- 9 Sep 2019 (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.
PURPOSE: this study aimed to investigate the effect of opposite knee position on hamstring flexibility BACKGROUND Hamstrings tightness is one of the most common findings in patients with LBP. It is thought that, due to the attachments of hamstrings to the ischial tuberosity, hamstrings tightness generates posterior pelvic tilt and decreases lumbar lordosis, which can result in LBP.
HYPOTHESES There will be significant difference in the hamstring flexibility with changing position of opposite knee (flexed or extended) in patients with mechanical low back pain.
RESEARCH QUESTION: Will changing position of opposite knee (flexed or extended) affect the hamstring flexibility in patients with mechanical low back pain?
Detailed description
- The subject will be instructed to maintain 90° hip flexion in the supine position.
- Then asked to actively extend the knee joint.
- The degree of achieving active knee extension will be measured using a universal goniometer.
- The average of three active knee extension measurements will be recorded used as the hamstring muscle length for the data analysis (Dong-Kyu Lee, et al., 2018).
- This test will be done for the same limb with opposite leg extended and with opposite flexed.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- * Male and female * Age range from 18-40 years old * With previous mentioned inclusion criteria
Key inclusion criteria (3 listed)
- Patients with history of back pain and assessed with Mechanical inflammatory low back pain index and have very high grade for mechanical component.
- Age ranges from 18-40 years.
- The body mass index of the subject is ≤25 kg/meter square.
Key exclusion criteria (5 listed)
- Previous trauma, fractures or surgery of the back.
- Malignancy of the back.
- Rheumatoid arthritis
- Spondylolysis or spondylolithesis
- History of lower extremity injury within 6 months prior to the study
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 |
|---|---|---|
| Hamstring FlexibilityThe active knee extension test has been proposed as the gold standard for assessment of hamstring flexibility, as it utilizes readily available equipment and offers a quick, reliable, and low-cost alternative for measurement of hamstring flexibility (Connor et al; 2015). * The subject will be instructed to maintain 90° hip flexion in the supine position. * Then asked to actively extend the knee joint. * The degree of achieving active knee extension will be measured using a universal goniometer. * The average of three active knee extension measurements will be used as the hamstring muscle length for the data analysis (Dong-Kyu Lee, et al; 2018). * the procedures will be done with opposite-leg flexed, then repeated with opposite-leg extended. | Other | – |
Primary outcome
Knee extension ROM
Time frame: 30 minutes
measuring knee extension ROM from 90 degrees hip flexion with opposite-leg flexed and extended
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 29 Jul 2021.
- 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.
Nasr A. Abdelkader, PhD principal investigator
Lecturer,Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Flexibility, 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 3 inclusion and 5 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 29 Jul 2021. 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?
Knee extension ROM (time frame: 30 minutes). 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 29 Jul 2021.