Efficacy of Iontophoresis in Treating Lateral Epicondylitis Patients

NOUR ALI ABO EL ELAA FRAGHLY

Status and phase: Enrolling; Phase 1

Conditions: Lateral Epicondylitis

Treatments: Other: conventional therapy; Drug: Magnesium sulfate

Study type: Interventional

Funder types: Other

Identifiers

NCT06578000

P.T.REC/012/004798

Details and patient eligibility

About

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.

Full 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?

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

group 1 ( Iontophoresis therapy (MgO4 will be applied to the active positive electrode))

Active Comparator group

Description:

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).

Treatment:

Drug: Magnesium sulfate

Other: conventional therapy

Control Group (2): conventional physical therapy treatment

Sham Comparator group

Description:

conventional therapy (Splint + Stretch + strength) twice a week for six weeks

Treatment:

Other: conventional therapy