Clinical trial NCT06578000: Efficacy of Iontophoresis in Treating Lateral Epicondylitis Patients
Official title: Efficacy of Iontophoresis in Treating Lateral Epicondylitis Patients a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lateral Epicondylitis
Keywords: iontophoresis
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2024-08-29
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be assigned randomly into 2 groups:

Group (A): Iontophoresis therapy (MgO4 will be applied to the active positive electrode and the treatment will be repeated twice a week for four weeks) + traditional therapy (Splint + Stretch + strength).

Group (B): conventional therapy (Splint + Stretch + strength) twice a week for six weeks
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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?

Eligibility criteria: Inclusion Criteria:

* • Their age will be ranged between 20-50 years with both gender

  * Pain on the lateral side of the elbow for at least 4 weeks
  * Tenderness over the lateral epicondyle
  * At least two positive provocative tests: Mill test and Thomson test

Exclusion Criteria:

* • History of injection, surgery, physical therapy in the elbow area in the last 3 months

  * Previous elbow surgery
  * History of radius/ulna fracture
  * History of cervical and shoulder problems
  * Having bilateral symptoms
  * Concomitant medial epicondylitis
  * Malignancy
  * Pregnancy
  * Systemic rheumatologic disease or systemic infection
  * Inserted cardiac pacemaker
  * Presence of coagulation disorders
  * Cognitive dysfunction

Primary outcomes:
measure: to investigate the effect of magnesium sulfate on pain intensity
timeFrame: 6 weeks
measure: investigate the effect of magnesium sulfate on muscle power in patients with lateral epicondylitis.
timeFrame: 6 weeks
measure: investigate the effect of magnesium sulfate on hand grip in patients with lateral epicondylitis.
timeFrame: 6 weeks
measure: investigate the effect of magnesium sulfate on function ability in patients with lateral epicondylitis.
timeFrame: 6 weeks
Secondary outcomes:
measure: Elbow range of motion
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
affiliation: Professor of Physical Therapy department for Basic sciences
name: Neveen Abd El latif Abdel Raoof, professor
role: STUDY_DIRECTOR
References: