UndefinedNCT05158985
Comparative Study Between Different Duty Cycles of Ultrasound Diclofenac Phonophoresis
A study testing phonophoresis and exercises in people with Undefined, run by October 6 University at 1 site in Egypt.
Trial summary
Lateral epicondylitis is a tendinopathy injury involving the extensor muscles of the forearm. These muscles originate on the lateral epicondylar region of the distal humerus. the insertion of the extensor carpi radialis brevis is involved in most cases. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Undefined
- What is being tested?
- phonophoresis and exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2020to 1 Nov 2022
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both sexes will be involved
- Duration of the disease is more than 12 weeks.
- Patient's age ranges from 20 to 40 years
Who cannot join
- Diabetic patients.
- Hypertension patients.
- Pregnant women
- Cardiovascular patients
- Patients with malunion fractures
- Patients with cervical Radiclopathy
- Patients with olecranon bursitis
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Emad MOHAMED
Cairo
Emad MOHAMED, 01146808839, Omdamohamed9111@gmail.com
About this study
Official title: Comparative Study Between Different Duty Cycles of Ultrasound Diclofenac Phonophoresis in Management of Chronic Lateral Epicondylitis: Randomized Controlled Trial
Lateral epicondylitis is a tendinopathy injury involving the extensor muscles of the forearm. These muscles originate on the lateral epicondylar region of the distal humerus. the insertion of the extensor carpi radialis brevis is involved in most cases. Transdermal administration of an anti-inflammatory drug to specific area is one of the methods that used to decrease inflammation and increase cell metabolism
Read the detailed description
Lateral epicondylitis is a soft-tissue lesion of the tendinous origin of the wrist extensor muscles at their origin on the lateral humeral epicondyle. The extensor carpi radialis brevis is the area of most pathologic changes. It begins as a microtear of the tendinous origin of the wrist extensor muscles and results in degeneration and reactive granulation tissue formation. Activities involving prolonged or repeated gripping, wrist extension, forearm supination, and pronation cause eventual failure of the affected portion of the tendon. The mechanical failure of the tendon results in an ensuring tendinitis and symptoms of lateral epicondylitis. It is aggravated with movements of the wrist, by palpation of the lateral side of elbow, or by contraction of extensor muscles of the wrist.
There are different treatment methods for lateral epicondylitis. Initially, lateral epicondylitis has been treated with ice, rest, counterforce tennis brace and/or non-steroidal anti-inflammatory drugs. But when the condition is not responding to initial treatment physical therapy is initiated
- Conditions
- Undefined
- Being tested
- phonophoresis, exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phonophoresisOther
treatment
exercisesOther
treatment
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | diclofenac sodium phonophoresis using continuous ultrasound with a frequency of 1MHz, an intensity of 1.5W/Cm2 for 4 minutes Receives: Other: phonophoresis |
| group B | Experimental | diclofenac sodium phonophoresis using pulsed US with 1:1 duty cycle with a frequency of 1MHz, an intensity of 1.5W/Cm2 for 4 minutes Receives: Other: phonophoresis |
| group C | Experimental | diclofenac sodium phonophoresis using pulsed US with 1:4 duty cycle with a frequency of 1MHz, an intensity of 1.5W/Cm2 for 10 minutes Receives: Other: phonophoresis |
| group D | Experimental | exercises only in form of (strengthening, stretching and occupational exercises). Receives: Other: exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale for pain intensity measurement
A VAS is usually a horizontal line, 100 mm in length, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain". The patient marks on the line the point that they feel represents their perception of their current state
Measured: 4 weeks
Hand grip dynamometer for hand grip measurement
The dynamometer has a dual scale readout which displays isometric grip force from 0-90 kg (0-200 lb). The outer dial registers the result in kg and the inner dial registers the result in lb. It has a peak hold needle which automatically retains the highest reading until the device is reset. The handle easily adjusts to five grip positions from 35-87 mm (1½ - 3¼") in 13 mm (½") increments. Always use the wrist strap to prevent the dynamometer from falling on the floor if accidentally dropped
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start15 May 2020
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UndefinedStudies 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
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- October 6 University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, basma osama, October 6 University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158985
- Sponsor's protocol ID
- 6786
- Status last verified
- Dec 2021
- First submitted
- 18 Nov 2021
- Last updated
- 15 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Different Duty Cycles of Ultrasound Diclofenac Phonophoresis in Management of Chronic Lateral Epicondylitis: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05158985
- Acronym / sponsor ID
- 6786
- Conditions
- Undefined
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- October 6 UniversityUniversity, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 15 Dec 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.
Lateral epicondylitis is a tendinopathy injury involving the extensor muscles of the forearm. These muscles originate on the lateral epicondylar region of the distal humerus. the insertion of the extensor carpi radialis brevis is involved in most cases. Transdermal administration of an anti-inflammatory drug to specific area is one of the methods that used to decrease inflammation and increase cell metabolism
Detailed description
Lateral epicondylitis is a soft-tissue lesion of the tendinous origin of the wrist extensor muscles at their origin on the lateral humeral epicondyle. The extensor carpi radialis brevis is the area of most pathologic changes. It begins as a microtear of the tendinous origin of the wrist extensor muscles and results in degeneration and reactive granulation tissue formation. Activities involving prolonged or repeated gripping, wrist extension, forearm supination, and pronation cause eventual failure of the affected portion of the tendon. The mechanical failure of the tendon results in an ensuring tendinitis and symptoms of lateral epicondylitis. It is aggravated with movements of the wrist, by palpation of the lateral side of elbow, or by contraction of extensor muscles of the wrist.
There are different treatment methods for lateral epicondylitis. Initially, lateral epicondylitis has been treated with ice, rest, counterforce tennis brace and/or non-steroidal anti-inflammatory drugs. But when the condition is not responding to initial treatment physical therapy is initiated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Other: phonophoresisdiclofenac sodium phonophoresis using continuous ultrasound with a frequency of 1MHz, an intensity of 1.5W/Cm2 for 4 minutes |
| group B | Experimental | Other: phonophoresisdiclofenac sodium phonophoresis using pulsed US with 1:1 duty cycle with a frequency of 1MHz, an intensity of 1.5W/Cm2 for 4 minutes |
| group C | Experimental | Other: phonophoresisdiclofenac sodium phonophoresis using pulsed US with 1:4 duty cycle with a frequency of 1MHz, an intensity of 1.5W/Cm2 for 10 minutes |
| group D | Experimental | Other: exercisesexercises only in form of (strengthening, stretching and occupational exercises). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both sexes will be involved
- Duration of the disease is more than 12 weeks.
- Patient's age ranges from 20 to 40 years
Key exclusion criteria (7 listed)
- Diabetic patients.
- Hypertension patients.
- Pregnant women
- Cardiovascular patients
- Patients with malunion fractures
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 |
|---|---|---|
| phonophoresistreatment | Other | group A, group B, group C |
| exercisestreatment | Other | group D |
Primary outcome
Visual analogue scale for pain intensity measurement
Time frame: 4 weeks
A VAS is usually a horizontal line, 100 mm in length, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain". The patient marks on the line the point that they feel represents their perception of their current state
Hand grip dynamometer for hand grip measurement
Time frame: 4 weeks
The dynamometer has a dual scale readout which displays isometric grip force from 0-90 kg (0-200 lb). The outer dial registers the result in kg and the inner dial registers the result in lb. It has a peak hold needle which automatically retains the highest reading until the device is reset. The handle easily adjusts to five grip positions from 35-87 mm (1½ - 3¼") in 13 mm (½") increments. Always use the wrist strap to prevent the dynamometer from falling on the floor if accidentally dropped
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing phonophoresis and exercises in people with Undefined, 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 7 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 15 Dec 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analogue scale for pain intensity measurement (time frame: 4 weeks). The study lists 2 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 15 Dec 2021.