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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Faculty of physical therapy, Cairo University

    Giza, 11432

Other trials in Egypt

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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05050695
Study groupRoleWhat they receive
Subjects with unilateral chronic low back painSubjects with low back pain for more than 3 months on one side of the spine
Healthy subjectsSubjects without a history of low back pain

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. 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

  3. 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.

  1. First posted20 Sep 2021
  2. Study start4 Oct 2021
  3. Primary completion25 Jan 2022
  4. Study completion25 Jan 2022

Resources

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)
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

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.

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