Chronic Low-back PainNCT05050695
Correlation Between Posterior Oblique Sling Activation and Contralateral Glenohumeral Stability in Low Back Pain
An observational study of Chronic Low-back Pain, run by Shaimaa Ramadan Ibrahim Abdul-ghani El Deab at 1 site in Egypt.
Trial summary
Objective: This study will be conducted to investigate the relationship between the amplitude of posterior oblique sling muscles; ipsilateral gluteus maximus (GM) and contralateral latissmus Dorsi (LD), and the amount of anterior translation of humeral head (ATHH) of the contralateral glenohumeral joint (GHJ) in… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Chronic Low-back Pain
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 4 Oct 2021to 25 Jan 2022
- 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 20 to 50 years
- All sexes
- Adult
Study population: Patients with CLBP will be recruited from the orthopedic outpatient clinic at Kasr El Ainy hospital and the outpatient clinic of the faculty of physical therapy, Cairo University. Healthy subjects will be recruited from the general population.
Who may be able to join
- Patients age between 20-50yrs
- Patients with chronic low back pain (pain > 3 months).
- Patients with unilateral symptoms (facet, disc, SIJ dysfunction) will be referred by an orthopedic physician with or without referral to the leg.
- 1. matched controls in terms of age, weight, height, and BMI.
Who cannot join
- History of shoulder pain 3 months ago.
- History of any shoulder pathology.
- Congenital pathology affecting the spine or shoulder.
- Any neurological disorder.
- Non-mechanical LBP (e.g., fracture, malignancy, infection)
- Difficulty performing the PHE task because of weakness in the GM or the test provokes pain.
- BMI 30 or higher as fat tissue may decrease the ability to measure surface EMG activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relationship Between Lumbopelvic Muscles Activity and Ultrasonographic Measurement of Contralateral Anterior Humeral Translation in Chronic Unilateral Low Back Pain
Objective: This study will be conducted to investigate the relationship between the amplitude of posterior oblique sling muscles; ipsilateral gluteus maximus (GM) and contralateral latissmus Dorsi (LD), and the amount of anterior translation of humeral head (ATHH) of the contralateral glenohumeral joint (GHJ) in subjects with unilateral chronic low back pain (CLBP) during ipsilateral prone knee extension (PHE) test. Methods: The study will be conducted on thirty subjects (15 patients with CLBP and 15 healthy subjects). Ipsilateral GM and contralateral LD amplitude will be recorded by surface EMG during PHE of the limb at the painful side and correlated to ATHH of contralateral GHJ as measured by ultrasonography. Hypothesis: There won't be a significant relationship between the amplitude of posterior oblique sling muscles (GM and contralateral LD) during PHE for the ipsilateral leg and the amount of ATHH of the contralateral GHJ in patients with unilateral CLBP.
Read the detailed description
Demographic data will be collected from all subjects regarding age, weight, height, and body mass index. After patient selection according to the inclusion and exclusion criteria, measuring the amplitude of gluteus maximus (GM) and contralateral latissmus dorsi (LD) muscles during prone hip extension (PHE) for the ipsilateral leg to the symptoms in unilateral CLBP patients and for the selected leg in matched controls will be carried out using surface electromyography (EMG) unit. Then ultrasonography unit will be used to assess the amount of anterior translation of humeral head (ATHH) of contralateral glenohumeral joint for both groups.
Before placement of the EMG electrodes, the skin at the anatomic landmarks will be shaved (if required), rubbed, and cleaned with isopropyl alcohol 70% to remove excess oils and debris.
The electrodes will be sterilized and placed on the muscle belly oriented parallel to the muscle fiber away from the tendon and muscle edges with the inter-electrodes distance of two centimeters. The electrodes will be secured by adhesive tape. Before recording, skin impedance will be checked to be less than 5 KΩ.
The electrodes for LD will be placed 4 cm below the inferior tip of the scapula and half the distance between the spine and the lateral edge of the torso. For GM, electrodes will be placed at half the distance between the greater trochanter and second sacral vertebra and at an oblique angle at, or slightly above, the level of the trochanter.
The two normalization procedures will be the typical maximal voluntary isometric contraction (MVIC) performed as per SENIAM Guidelines (www.seniam.org), and submaximal voluntary contraction (sub-MVC) task will be performed using the prone double leg raise. It is recommended to avoid maximal contractions of the GM muscle, because reproduction of pain on testing would have possibly invalidated the use of the root mean square (RMS) values for normalization.
For the sub-MVC of GM, the subjects will be asked to lift both knees 5 cm off the examination table while the knees should be flexed at 90 and held them for 5 seconds in a prone position. Three trials will be performed with 30 seconds rest in between.
For MVIC of LD muscle, the subjects will be in prone position and the side being tested is aligned with the edge of the plinth, with the shoulder and upper extremity off the plinth. The subjects will be asked to flex the elbow and manual isometric resistance will be applied at distal humerus during shoulder extension and adduction and the contraction held for 5 seconds, the middle 3 seconds will be used for the analysis. Stabilization will be applied to the ipsilateral scapula and trunk. Three trials were performed with 30 seconds rest in between.
For recording during PHE, all subjects will be instructed about active PHE and The target angle was set at 10 degrees to control the amount of hip extension using a goniometer. A 30 seconds rest period will be provided between each trial.
Ultrasonography assessment: the patient will be assessed in a sitting position and the shoulder will be placed in internal rotation then the position will be maintained by a sling. Two therapists are needed to assess humeral translation.
- Conditions
- Chronic Low-back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with unilateral chronic low back pain | Subjects with low back pain for more than 3 months on one side of the spine | |
| Healthy subjects | Subjects without a history of low back pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amplitude of gluteus maximus muscle
Investigator will collect the EMG activity of gluteus maximus during PHE using two silver surface recording electrodes for bipolar configuration
Measured: From admission to discharge, up to two weeks
Amplitude of latissimus dorsi muscle
Investigator will collect the EMG activity of latissimus dorsi during PHE using two silver surface recording electrodes for bipolar configuration
Measured: From admission to discharge, up to two weeks
Anterior translation of humeral head
Investigators will assess the anterior humeral translation using ultrasonography
Measured: From admission to discharge, up to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start4 Oct 2021
- Primary completion25 Jan 2022
- Study completion25 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaimaa Ramadan Ibrahim Abdul-ghani El Deab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shaimaa Ramadan Ibrahim Abdul-ghani El Deab, Cairo University
- Investigators
- Bassem G. El Nahass, Professor, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050695
- Sponsor's protocol ID
- P.T.REC/012/001843
- Status last verified
- Jul 2022
- First submitted
- 11 Sep 2021
- Last updated
- 22 Jul 2022
- 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 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Lumbopelvic Muscles Activity and Ultrasonographic Measurement of Contralateral Anterior Humeral Translation in Chronic Unilateral Low Back Pain
- ClinicalTrials.gov ID
- NCT05050695
- Acronym / sponsor ID
- P.T.REC/012/001843
- Conditions
- Chronic Low-back Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Shaimaa Ramadan Ibrahim Abdul-ghani El DeabUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 25 Jan 2022 (actual)
- Study completion
- 25 Jan 2022 (actual)
- First posted
- 20 Sep 2021 (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.
Objective: This study will be conducted to investigate the relationship between the amplitude of posterior oblique sling muscles; ipsilateral gluteus maximus (GM) and contralateral latissmus Dorsi (LD), and the amount of anterior translation of humeral head (ATHH) of the contralateral glenohumeral joint (GHJ) in subjects with unilateral chronic low back pain (CLBP) during ipsilateral prone knee extension (PHE) test. Methods: The study will be conducted on thirty subjects (15 patients with CLBP and 15 healthy subjects). Ipsilateral GM and contralateral LD amplitude will be recorded by surface EMG during PHE of the limb at the painful side and correlated to ATHH of contralateral GHJ as measured by ultrasonography. Hypothesis: There won't be a significant relationship between the amplitude of posterior oblique sling muscles (GM and contralateral LD) during PHE for the ipsilateral leg and the amount of ATHH of the contralateral GHJ in patients with unilateral CLBP.
Detailed description
Demographic data will be collected from all subjects regarding age, weight, height, and body mass index. After patient selection according to the inclusion and exclusion criteria, measuring the amplitude of gluteus maximus (GM) and contralateral latissmus dorsi (LD) muscles during prone hip extension (PHE) for the ipsilateral leg to the symptoms in unilateral CLBP patients and for the selected leg in matched controls will be carried out using surface electromyography (EMG) unit. Then ultrasonography unit will be used to assess the amount of anterior translation of humeral head (ATHH) of contralateral glenohumeral joint for both groups.
Before placement of the EMG electrodes, the skin at the anatomic landmarks will be shaved (if required), rubbed, and cleaned with isopropyl alcohol 70% to remove excess oils and debris.
The electrodes will be sterilized and placed on the muscle belly oriented parallel to the muscle fiber away from the tendon and muscle edges with the inter-electrodes distance of two centimeters. The electrodes will be secured by adhesive tape. Before recording, skin impedance will be checked to be less than 5 KΩ.
The electrodes for LD will be placed 4 cm below the inferior tip of the scapula and half the distance between the spine and the lateral edge of the torso. For GM, electrodes will be placed at half the distance between the greater trochanter and second sacral vertebra and at an oblique angle at, or slightly above, the level of the trochanter.
The two normalization procedures will be the typical maximal voluntary isometric contraction (MVIC) performed as per SENIAM Guidelines (www.seniam.org), and submaximal voluntary contraction (sub-MVC) task will be performed using the prone double leg raise. It is recommended to avoid maximal contractions of the GM muscle, because reproduction of pain on testing would have possibly invalidated the use of the root mean square (RMS) values for normalization.
For the sub-MVC of GM, the subjects will be asked to lift both knees 5 cm off the examination table while the knees should be flexed at 90 and held them for 5 seconds in a prone position. Three trials will be performed with 30 seconds rest in between.
For MVIC of LD muscle, the subjects will be in prone position and the side being tested is aligned with the edge of the plinth, with the shoulder and upper extremity off the plinth. The subjects will be asked to flex the elbow and manual isometric resistance will be applied at distal humerus during shoulder extension and adduction and the contraction held for 5 seconds, the middle 3 seconds will be used for the analysis. Stabilization will be applied to the ipsilateral scapula and trunk. Three trials were performed with 30 seconds rest in between.
For recording during PHE, all subjects will be instructed about active PHE and The target angle was set at 10 degrees to control the amount of hip extension using a goniometer. A 30 seconds rest period will be provided between each trial.
Ultrasonography assessment: the patient will be assessed in a sitting position and the shoulder will be placed in internal rotation then the position will be maintained by a sling. Two therapists are needed to assess humeral translation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with unilateral chronic low back pain | – | –Subjects with low back pain for more than 3 months on one side of the spine |
| Healthy subjects | – | –Subjects without a history of low back pain |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients with CLBP will be recruited from the orthopedic outpatient clinic at Kasr El Ainy hospital and the outpatient clinic of the faculty of physical therapy, Cairo University. Healthy subjects will be recruited from the general population.
Key inclusion criteria (4 listed)
- Patients age between 20-50yrs
- Patients with chronic low back pain (pain > 3 months).
- Patients with unilateral symptoms (facet, disc, SIJ dysfunction) will be referred by an orthopedic physician with or without referral to the leg.
- 1. matched controls in terms of age, weight, height, and BMI.
Key exclusion criteria (7 listed)
- History of shoulder pain 3 months ago.
- History of any shoulder pathology.
- Congenital pathology affecting the spine or shoulder.
- Any neurological disorder.
- Non-mechanical LBP (e.g., fracture, malignancy, infection)
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
Amplitude of gluteus maximus muscle
Time frame: From admission to discharge, up to two weeks
Investigator will collect the EMG activity of gluteus maximus during PHE using two silver surface recording electrodes for bipolar configuration
Amplitude of latissimus dorsi muscle
Time frame: From admission to discharge, up to two weeks
Investigator will collect the EMG activity of latissimus dorsi during PHE using two silver surface recording electrodes for bipolar configuration
Anterior translation of humeral head
Time frame: From admission to discharge, up to two weeks
Investigators will assess the anterior humeral translation using ultrasonography
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 22 Jul 2022.
- 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.
Bassem G. El Nahass, 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?
An observational study of Chronic Low-back Pain, run by Shaimaa Ramadan Ibrahim Abdul-ghani El Deab 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 4 inclusion and 7 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 22 Jul 2022. 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?
Amplitude of gluteus maximus muscle (time frame: From admission to discharge, up to two weeks). The study lists 3 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 22 Jul 2022.