Tennis ElbowNCT05084664
Effect of Premodulated Current Versus Diadynamic Current On the Management of Tennis Elbow.
A study testing electrical stimulation in people with Tennis Elbow, run by October 6 University at 1 site in Egypt.
Trial summary
104 patients with unilateral tennis elbow from both genders (57 females and 43 males) referred by orthopaedist with age ranged between 20 and 60 years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- electrical stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Oct 2020to 1 Oct 2021
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients suffer from pain at the lateral part of the elbow and radiated to the forearm with tenderness increasing on pressure on the lateral epicondyle and on resistance of hand extension
- lasting of the symptoms for 3 months
- previous physiotherapy interventions.
Who cannot join
- Internal or external fixation
- arthritis of elbow
- contraindications to electrotherapy like pacemaker, dermatological skin disease, epilepsy, abnormal sensation, and pregnancy.
Trial locations and contacts
1 site in 1 country.
About this study
104 patients with unilateral tennis elbow from both genders (57 females and 43 males) referred by orthopaedist with age ranged between 20 and 60 years.
Read the detailed description
hey were recruited in the study from October 2020 to September 2021 and allocated randomly into two groups. Group A received premodulated current in addition to exercises, and group B received diadynamic current with the same exercises. Each patient signed the informed consent form approved by the faculty of physical therapy, October 6 university, Egypt and prospectively registered (Clinical Trials.gov, Identifier NCT03338283). Patients was selected according to the following criteria.
Inclusive criteria
- Patients suffer from pain at the lateral part of the elbow and radiated to the forearm with tenderness increasing on pressure on the lateral epicondyle and on resistance of hand extension
- lasting of the symptoms for 3 months
- no previous physiotherapy interventions.
Exclusive criteria
Internal or external fixation
- arthritis of elbow
- contraindications to electrotherapy like pacemaker, dermatological skin disease, epilepsy, abnormal sensation, and pregnancy.
- Conditions
- Tennis Elbow
- Being tested
- electrical stimulation
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electrical stimulationDevice
premodulated current+ exercises
electrical stimulationDevice
diadynamic current+ exercises
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | premodulated current Receives: Device: electrical stimulation |
| group B | Experimental | diadynamic current Receives: Device: electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
baseline hydraulic hand dynamometer
grip strength measurement (200 lb.90 kg Capacity)
Measured: 6 weeks
Patient-Rated Tennis Elbow Evaluation (PRTEE)
pain and functional measurement (The maximum score is 50 for the pain subscale and 100 for the function subscale)
Measured: 6 weeks
baseline hydraulic pinch gauge
pinch measurement (50 lb.22.5 kg Capacity)
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 posted20 Oct 2021
- Study start15 Oct 2020
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Eldin Mohamed, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084664
- Sponsor's protocol ID
- 897
- Status last verified
- Oct 2021
- First submitted
- 6 Oct 2021
- Last updated
- 28 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Premodulated Current Versus Diadynamic Current On the Management of Tennis Elbow.
- ClinicalTrials.gov ID
- NCT05084664
- Acronym / sponsor ID
- 897
- Conditions
- Tennis Elbow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 20 Oct 2021 (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.
104 patients with unilateral tennis elbow from both genders (57 females and 43 males) referred by orthopaedist with age ranged between 20 and 60 years.
Detailed description
hey were recruited in the study from October 2020 to September 2021 and allocated randomly into two groups. Group A received premodulated current in addition to exercises, and group B received diadynamic current with the same exercises. Each patient signed the informed consent form approved by the faculty of physical therapy, October 6 university, Egypt and prospectively registered (Clinical Trials.gov, Identifier NCT03338283). Patients was selected according to the following criteria.
Inclusive criteria
- Patients suffer from pain at the lateral part of the elbow and radiated to the forearm with tenderness increasing on pressure on the lateral epicondyle and on resistance of hand extension
- lasting of the symptoms for 3 months
- no previous physiotherapy interventions.
Exclusive criteria
Internal or external fixation
- arthritis of elbow
- contraindications to electrotherapy like pacemaker, dermatological skin disease, epilepsy, abnormal sensation, and pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Device: electrical stimulationpremodulated current |
| group B | Experimental | Device: electrical stimulationdiadynamic current |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients suffer from pain at the lateral part of the elbow and radiated to the forearm with tenderness increasing on pressure on the lateral epicondyle and on resistance of hand extension
- lasting of the symptoms for 3 months
- previous physiotherapy interventions.
Key exclusion criteria (3 listed)
- Internal or external fixation
- arthritis of elbow
- contraindications to electrotherapy like pacemaker, dermatological skin disease, epilepsy, abnormal sensation, and pregnancy.
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 |
|---|---|---|
| electrical stimulationpremodulated current+ exercises | Device | group A |
| electrical stimulationdiadynamic current+ exercises | Device | group B |
Primary outcome
baseline hydraulic hand dynamometer
Time frame: 6 weeks
grip strength measurement (200 lb.90 kg Capacity)
Patient-Rated Tennis Elbow Evaluation (PRTEE)
Time frame: 6 weeks
pain and functional measurement (The maximum score is 50 for the pain subscale and 100 for the function subscale)
baseline hydraulic pinch gauge
Time frame: 6 weeks
pinch measurement (50 lb.22.5 kg Capacity)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2021.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electrical stimulation in people with Tennis Elbow, run by October 6 University 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 28 Oct 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
baseline hydraulic hand dynamometer (time frame: 6 weeks). The study lists 3 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 28 Oct 2021.