- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05050695
Correlation Between Posterior Oblique Sling Activation and Contralateral Glenohumeral Stability in Low Back Pain
Relationship Between Lumbopelvic Muscles Activity and Ultrasonographic Measurement of Contralateral Anterior Humeral Translation in Chronic Unilateral Low Back Pain
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Giza, Egypt, 11432
- faculty of physical therapy, Cairo university
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria for CLBP group:
- 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.
Inclusion Criteria for the healthy control group:
1. matched controls in terms of age, weight, height, and BMI.
Exclusion Criteria for both groups:
- 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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Subjects with unilateral chronic low back pain
Subjects with low back pain for more than 3 months on one side of the spine
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Healthy subjects
Subjects without a history of low back pain
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Amplitude of gluteus maximus muscle
Time Frame: From admission to discharge, up to two weeks
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Investigator will collect the EMG activity of gluteus maximus during PHE using two silver surface recording electrodes for bipolar configuration
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From admission to discharge, up to two weeks
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Amplitude of latissimus dorsi muscle
Time Frame: From admission to discharge, up to two weeks
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Investigator will collect the EMG activity of latissimus dorsi during PHE using two silver surface recording electrodes for bipolar configuration
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From admission to discharge, up to two weeks
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Anterior translation of humeral head
Time Frame: From admission to discharge, up to two weeks
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Investigators will assess the anterior humeral translation using ultrasonography
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From admission to discharge, up to two weeks
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Collaborators and Investigators
Investigators
- Study Director: Bassem G. El Nahass, Professor, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/001843
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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