Mechanical Low Back PainNCT04562701
Relationship Between Hamstring Length and Gluteus Maximums in Mechanical Low Back Pain
An observational study of Mechanical Low Back Pain, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study was to determine the correlation between hamstring length and gluteus maximus strength with and without normalization in patients with mechanical low back pain Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Mechanical Low Back Pain
- How many people
- 73 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2018to 31 Aug 2020
- 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
- No healthy volunteers
- Adult
Study population: * Male and female patients * Age ranged from 18-40 years * Body mass index ranged from 25-30 kg/m2
Who may be able to join
- Patients diagnosed as mechanical low back pain (MLBP) with very high grade mechanical inflammatory low back pain (MIL) index.
- Age ranged from 18 to 40 years.
- Body mass index ranged from 25 to 30 kg/m2
Who cannot join
- History of previous fractures, surgeries, malignancies, trauma, rheumatoid arthritis, spondylosis, and spondylolisthesis.
- History of lower limb injuries in the last six months before the study.
- Inability to correctly produce maximal Gluteus Maximus contraction in a pain-free ROM.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Hamstring Length and Gluteus Maximums Strength With and Without Normalization in Mechanical Low Back Pain
The aim of this study was to determine the correlation between hamstring length and gluteus maximus strength with and without normalization in patients with mechanical low back pain
Read the detailed description
seventy-three patients diagnosed as mechanical low back pain. Firstly, gluteus maximus (GM) strength was measured isometrically as a force (kg) and then converted to torque (Nm). GM strength was normalized for body weight and height using the following formula: % (body weight × h) = torque (N × m) ×100 / body weight (N) × h (m), then assessment of hamstring length flexibility using the active knee extension method.
Data was collected and the correlation was determined.
- Conditions
- Mechanical Low Back Pain
- Medical subject headings
- Low Back Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Gluteus muscle torque
The gluteus maximus strength was evaluated by using hand-held dynamometer (HHD). The patient was asked to lie in the prone position. Belt was used to support the pelvis, then the patient was asked to maximally extend the hip joint with the knee joints flexed to 90°). Resistance belt (non-elastic strap) was placed 15 cm above the knee joint above popliteal fossa with the Hand-held dynamometer below it. Each subject was instructed to perform maximal isometric hip extension for 5 seconds. Measurement was done three times, with 2-minutes rest between trials. Subject's hand was places behind waist to control the substitute motions of arm or hand. The peak force for each trial was recorded, and the average value was calculated
Measured: 20 minutes
Hamstring length
Patient was positioned supine with the non-tested limb flat with knee extended and supported with strap over the mid-thigh to eliminate any substitutive movement. An another strap was rapped over the pelvis for fixation, to maintain 90 degrees of the hip joint, a wooden frame was then placed on the plinth in line with the participant's anterior superior iliac spine of the pelvis. The participant was asked to flex the hip of the test leg so that their thigh touching the wooden apparatus all over test time
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start10 Sep 2018
- Primary completion5 Jan 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Prof.Dr Nadia Abdelazim fayaz, Walaa Mohsen Mohamed, Nagy Sabet, Hamada Ahmad Hamada
- Responsible party
- Principal investigator, Nasr Awad Abdelkader Othman, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562701
- Sponsor's protocol ID
- P.T.REC/012/002047
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2020
- Last updated
- 6 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Hamstring Length and Gluteus Maximums Strength With and Without Normalization in Mechanical Low Back Pain
- ClinicalTrials.gov ID
- NCT04562701
- Acronym / sponsor ID
- P.T.REC/012/002047
- Conditions
- Mechanical Low Back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Prof.Dr Nadia Abdelazim fayaz, Walaa Mohsen Mohamed, Nagy Sabet, Hamada Ahmad Hamada
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 5 Jan 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 24 Sep 2020 (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.
The aim of this study was to determine the correlation between hamstring length and gluteus maximus strength with and without normalization in patients with mechanical low back pain
Detailed description
seventy-three patients diagnosed as mechanical low back pain. Firstly, gluteus maximus (GM) strength was measured isometrically as a force (kg) and then converted to torque (Nm). GM strength was normalized for body weight and height using the following formula: % (body weight × h) = torque (N × m) ×100 / body weight (N) × h (m), then assessment of hamstring length flexibility using the active knee extension method.
Data was collected and the correlation was determined.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- * Male and female patients * Age ranged from 18-40 years * Body mass index ranged from 25-30 kg/m2
Key inclusion criteria (3 listed)
- Patients diagnosed as mechanical low back pain (MLBP) with very high grade mechanical inflammatory low back pain (MIL) index.
- Age ranged from 18 to 40 years.
- Body mass index ranged from 25 to 30 kg/m2
Key exclusion criteria (3 listed)
- History of previous fractures, surgeries, malignancies, trauma, rheumatoid arthritis, spondylosis, and spondylolisthesis.
- History of lower limb injuries in the last six months before the study.
- Inability to correctly produce maximal Gluteus Maximus contraction in a pain-free ROM.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gluteus muscle torque
Time frame: 20 minutes
The gluteus maximus strength was evaluated by using hand-held dynamometer (HHD). The patient was asked to lie in the prone position. Belt was used to support the pelvis, then the patient was asked to maximally extend the hip joint with the knee joints flexed to 90°). Resistance belt (non-elastic strap) was placed 15 cm above the knee joint above popliteal fossa with the Hand-held dynamometer below it. Each subject was instructed to perform maximal isometric hip extension for 5 seconds. Measurement was done three times, with 2-minutes rest between trials. Subject's hand was places behind waist to control the substitute motions of arm or hand. The peak force for each trial was recorded, and the average value was calculated
Hamstring length
Time frame: 20 minutes
Patient was positioned supine with the non-tested limb flat with knee extended and supported with strap over the mid-thigh to eliminate any substitutive movement. An another strap was rapped over the pelvis for fixation, to maintain 90 degrees of the hip joint, a wooden frame was then placed on the plinth in line with the participant's anterior superior iliac spine of the pelvis. The participant was asked to flex the hip of the test leg so that their thigh touching the wooden apparatus all over test time
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 6 Oct 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mechanical 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 3 inclusion and 3 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 6 Oct 2020. 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?
Gluteus muscle torque (time frame: 20 minutes). 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 6 Oct 2020.