Efficacy of Iontophoresis in Treating Lateral Epicondylitis Patients (Iontophoresis)

August 27, 2024 updated by: NOUR ALI ABO EL ELAA FRAGHLY

Efficacy of Iontophoresis in Treating Lateral Epicondylitis Patients a Randomised Controlled Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of Physical Therapy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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).
Drug: 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).
Other: conventional therapy
conventional therapy (Splint + Stretch + strength) twice a week for six weeks
Sham Comparator: Control Group (2): conventional physical therapy treatment
conventional therapy (Splint + Stretch + strength) twice a week for six weeks
Other: conventional therapy
conventional therapy (Splint + Stretch + strength) twice a week for six weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
to investigate the effect of magnesium sulfate on pain intensity
Time Frame: 6 weeks
. 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
6 weeks
investigate the effect of magnesium sulfate on muscle power in patients with lateral epicondylitis.
Time Frame: 6 weeks
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
6 weeks
investigate the effect of magnesium sulfate on hand grip in patients with lateral epicondylitis.
Time Frame: 6 weeks
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
6 weeks
investigate the effect of magnesium sulfate on function ability in patients with lateral epicondylitis.
Time Frame: 6 weeks
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)
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Elbow range of motion
Time Frame: 6 weeks

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).
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NOUR ALI ABO EL ELAA FRAGHLY

Collaborators

Cairo University

Investigators

  • Study Director: Neveen Abd El latif Abdel Raoof, professor, Professor of Physical Therapy department for Basic sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

March 2, 2025

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

August 27, 2024

First Posted (Actual)

August 29, 2024

Study Record Updates

Last Update Posted (Actual)

August 29, 2024

Last Update Submitted That Met QC Criteria

August 27, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P.T.REC/012/004798

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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