A Phase 1 interventional study of Magnesium sulfate and conventional therapy in Lateral Epicondylitis, sponsored by NOUR ALI ABO EL ELAA FRAGHLY. Recruiting at 1 site in Egypt. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-08-29.
Sponsored by NOUR ALI ABO EL ELAA FRAGHLY · Phase 1, Interventional, and Treatment
This study is conducted To evaluate the effect of magnesium sulfate on pain intensity, muscle power, hand grip and function ability in patients with lateral epicondylitis.
This study is conducted To evaluate the effect of magnesium sulfate on pain intensity, muscle power, hand grip and function ability in patients with lateral epicondylitis.
BACKGROUND:
Lateral epicondylitis (LE) (tennis elbow) is a tendinopathy of the forearm extensor muscles, often caused by overuse or repetitive use (mostly of the extensor carpi radialis brevis), forced extension or direct trauma in the epicondyle . LE has an approximate rate of 40% and a prevalence of 1-3% of the general population . It mostly affects people 40 years and older. Some studies indicate that men and women are equally affected; others report a higher percentage of affected women .
HYPOTHESES
It will be hypothesized that:
There will be no statistically significant effect of magnesium sulfate on pain intensity, muscle power, hand grip and function ability in patients with lateral epicondylitis.
Definition of terms Lateral epicondylitis: pain and tenderness over the lateral epicondyle of the humerus, and pain on resisted dorsiflexion of the wrist, middle finger, or both .
Iontophoresis: is a technique used to enhance transdermal penetration of substances through the application of electric current .
RESEARCH QUESTION:
This study will be conducted to answer the following question:
What is the effect of magnesium sulfate on pain intensity, muscle power, hand grip and function ability in patients with lateral epicondylitis?
284 studies on the registry are indexed under Tennis Elbow; 60 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 253 interventional studies indexed under Tennis Elbow.
Browse Tennis Elbow studies →This is the only study on the registry with NOUR ALI ABO EL ELAA FRAGHLY as lead sponsor.
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Their age will be ranged between 20-50 years with both gender
Exclusion Criteria:
History of injection, surgery, physical therapy in the elbow area in the last 3 months
Iontophoresis therapy (MgO4 will be applied to the active positive electrode and the treatment will be repeated twice a week for four weeks) + conventional therapy (Splint + Stretch + strength).
Drug: Magnesium sulfate · Other: conventional therapy
conventional therapy (Splint + Stretch + strength) twice a week for six weeks
Other: conventional therapy
Iontophoresis therapy (MgO4 will be applied to the active positive electrode and the treatment will be repeated twice a week for four weeks) + conventional therapy (Splint + Stretch + strength).
conventional therapy (Splint + Stretch + strength) twice a week for six weeks
to investigate the effect of magnesium sulfate on pain intensity
. Visual analogue scale will be used to assess the pain intensity level. Pain intensity Level will be measured using the VAS that consists of a 10-cm straight line with endpoints defining pain intensity.All patients will be asked to mark their pain level that corresponds to their pain intensity on the line between "0", representing "no pain", and "10", representing "the worst pain imaginable". The distance between "0" and the mark made by the patients was measured. Difference in pain intensity will be recorded at rest, at night, and during activity (repeated elbow movement) at baseline and after treatment
Time frame: 6 weeks
investigate the effect of magnesium sulfate on muscle power in patients with lateral epicondylitis.
Cyriax Resisted Muscle Test: In this test, the patients will be seated and positioned with their upper extremities relaxed. The test will include elbow extension, third finger extension, pronation, and supination. All tests were conducted in a standardized manner using maximal isometric resistance and allowing no movement at either joint. Based on manual muscle testing principles, the examiner will hold the contraction for approximately 3 s to allow the patients time to build to maximum tension. The examiner will stabilize the patients' elbows with one hand and applied resistance with other hand. The patients will be instructed to report the onset of or an increase in pain. The results of the resisted tests will be recorded as "strong and painless", "strong and painful", "weak and painful", and "weak and painless". The Cyriax Resisted Muscle Test was conducted at baseline and after treatment
Time frame: 6 weeks
investigate the effect of magnesium sulfate on hand grip in patients with lateral epicondylitis.
Maximum grip strength: by using hand dynamometer the patients will be seated on an armless chair with 90° flexion of hip and knee, their shoulders with 0° abduction and in the neutral position, their elbow at 90° flexion and their forearm in the neutral position, and their wrist in semi pronation with an upright thumb to provide a stronger grip. The protocol will consist of three maximal isometric contractions without pain for 5 s with a rest period of at least 60 s. The patients will perform three trials of grip strength using their involved and non-involved hands while maintaining 90° elbow flexion and neutral forearm position. The patients followed a verbal command of "slowly push, push, push, push, and relax" for each isometric contraction to ensure that the contractions lasted for approximately 5 s. The patients will be also asked to squeeze the dynamometer as hard as possible without the sensation of pain. The mean strength of three measurements will be recorded in kilograms
Time frame: 6 weeks
investigate the effect of magnesium sulfate on function ability in patients with lateral epicondylitis.
The elbow functionality will be determined using the Patient-Rated Tennis Elbow Evaluation Scale (PRTEE) appendix II. The PRTEE is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis. The patients must rate their levels of pain and disability from 0 to 10. There are two subscales: the pain subscale (0 = no pain, 10 = worst pain imaginable) and the function subscale (0 = no difficulty, 10 = unable to do)
Time frame: 6 weeks
Elbow range of motion
Joint range of motion evaluation: With the wrist in neutral position, the angle achieved during maximum wrist extension was assessed using the Clinometer (Plaincode Software Solution, Stephanskirchen, Germany) which is a smartphone application. The forearm placed on the chair armrest, with 90 degrees of elbow flexion, the angle between the radius and the second metacarpal was measured by the radial styloid axis of the forearm in pronation. The interrater reliability for angular measurements was 0.76-0.95 (Lim and Shin, 2016).
Time frame: 6 weeks
Plan to share: Undecided
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