Efficacy of Iontophoresis in Treating Lateral Epicondylitis Patients

NCT06578000 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: P.T.REC/012/004798
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Lateral Epicondylitis

Keywords

iontophoresis

Outcome Measures

Primary Outcomes (4)

• 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

  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

  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

  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)

  6 weeks

Secondary Outcomes (1)

• Elbow range of motion

  6 weeks

Study Arms (2)

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

ACTIVE COMPARATOR

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

Control Group (2): conventional physical therapy treatment

SHAM COMPARATOR

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

Other: conventional therapy

Interventions

Magnesium sulfate 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).

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

conventional therapy OTHER

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

Control Group (2): conventional physical therapy treatment; group 1 ( Iontophoresis therapy (MgO4 will be applied to the active positive electrode))

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NOUR ALI ABO EL ELAA FRAGHLY: lead
• Cairo University: collaborator

Study Sites (1)

Faculty of Physical Therapy

Cairo, Egypt

RECRUITING

MeSH Terms

Conditions

Tennis Elbow

Interventions

Magnesium Sulfate

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Neveen Abd El latif Abdel Raoof, professor

  Professor of Physical Therapy department for Basic sciences

  STUDY DIRECTOR

Central Study Contacts

nour ali abo el elaa, master

CONTACT

01094856155; noor.ali@pt.seuz.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer assistant

Model Details: 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

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 29, 2024
• Study Start: September 1, 2024
• Primary Completion: November 30, 2024
• Study Completion: March 2, 2025
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

EG (1)