Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05050695 |
Other study ID # |
P.T.REC/012/001843 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
October 4, 2021 |
Est. completion date |
January 25, 2022 |
Study information
Verified date |
July 2022 |
Source |
Cairo University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical 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 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.
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.