Efficacy of Iontophoresis in Treating Lateral Epicondylitis Patients

NCT ID: NCT06578000

Last Updated: 2024-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2025-03-02

Brief Summary

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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

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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?

Conditions

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Lateral Epicondylitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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

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).

Group Type ACTIVE_COMPARATOR

Magnesium sulfate

Intervention Type DRUG

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

Intervention Type OTHER

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

Control Group (2): conventional physical therapy treatment

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

Group Type SHAM_COMPARATOR

conventional therapy

Intervention Type OTHER

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

Interventions

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Magnesium sulfate

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).

Intervention Type DRUG

conventional therapy

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

NOUR ALI ABO EL ELAA FRAGHLY

OTHER

Sponsor Role lead

Responsible Party

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NOUR ALI ABO EL ELAA FRAGHLY

Lecturer assistant

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Neveen Abd El latif Abdel Raoof, professor

Role: STUDY_DIRECTOR

Professor of Physical Therapy department for Basic sciences

Locations

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Faculty of Physical Therapy

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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nour ali abo el elaa, master

Role: CONTACT

01094856155

Other Identifiers

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P.T.REC/012/004798

Identifier Type: -

Identifier Source: org_study_id

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