Lateral EpicondylitisPhase 1IontophoresisNCT06578000
Efficacy of Iontophoresis in Treating Lateral Epicondylitis Patients
A Phase 1 study testing Magnesium sulfate and conventional therapy in people with Lateral Epicondylitis, run by NOUR ALI ABO EL ELAA FRAGHLY at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Magnesium sulfate and conventional therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 2 Mar 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • 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
Who cannot join
- • 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
Show all 12Show fewer
- Malignancy
- Pregnancy
- Systemic rheumatologic disease or systemic infection
- Inserted cardiac pacemaker
- Presence of coagulation disorders
- Cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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?
- Conditions
- Lateral Epicondylitis
- Being tested
- Magnesium sulfate, conventional therapy
- Keywords
- iontophoresis
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnesium sulfateDrug
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 therapyOther
conventional therapy (Splint + Stretch + strength) twice a week for six weeks
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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 Receives: Other: conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 6 weeks
Secondary outcomes (1)
Elbow range of motion
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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion30 Nov 2024 (estimated)
- Study completion2 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NOUR ALI ABO EL ELAA FRAGHLY
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, NOUR ALI ABO EL ELAA FRAGHLY, Cairo University
- Investigators
- Neveen Abd El latif Abdel Raoof, professor, Study director, Professor of Physical Therapy department for Basic sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578000
- Sponsor's protocol ID
- P.T.REC/012/004798
- Acronym
- Iontophoresis
- Status last verified
- Aug 2024
- First submitted
- 21 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Iontophoresis in Treating Lateral Epicondylitis Patients a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06578000
- Acronym / sponsor ID
- Iontophoresis / P.T.REC/012/004798
- Conditions
- Lateral Epicondylitis
- Keywords
- iontophoresis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- NOUR ALI ABO EL ELAA FRAGHLYUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 2 Mar 2025 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| group 1 ( Iontophoresis therapy (MgO4 will be applied to the active positive electrode)) | Active comparator | Drug: Magnesium sulfate, Other: conventional therapyIontophoresis 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). |
| Control Group (2): conventional physical therapy treatment | Sham comparator | Other: conventional therapyconventional therapy (Splint + Stretch + strength) twice a week for six weeks |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Their age will be ranged between 20-50 years with both gender
Key exclusion criteria (12 listed)
- • History of injection, surgery, physical therapy in the elbow area in the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnesium sulfateIontophoresis 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 | group 1 ( Iontophoresis therapy (MgO4 will be applied to the active positive electrode)) |
| conventional therapyconventional therapy (Splint + Stretch + strength) twice a week for six weeks | Other | Control Group (2): conventional physical therapy treatment, group 1 ( Iontophoresis therapy (MgO4 will be applied to the active positive electrode)) |
Primary outcome
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
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
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
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)
1 secondary outcome
Elbow range of motion
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neveen Abd El latif Abdel Raoof, professor study director
Professor of Physical Therapy department for Basic sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Magnesium sulfate and conventional therapy in people with Lateral Epicondylitis, run by NOUR ALI ABO EL ELAA FRAGHLY at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nour ali abo el elaa, master (01094856155, noor.ali@pt.seuz.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to investigate the effect of magnesium sulfate on pain intensity (time frame: 6 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2024; AzTrials last refreshed its copy on 8 Nov 2026.