Comparative Study Between Different Duty Cycles of Ultrasound Diclofenac Phonophoresis
1 other identifier
interventional
76
1 country
1
Brief 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. Transdermal administration of an anti-inflammatory drug to specific area is one of the methods that used to decrease inflammation and increase cell metabolism
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2020
CompletedFirst Submitted
Initial submission to the registry
November 18, 2021
CompletedFirst Posted
Study publicly available on registry
December 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2022
CompletedDecember 15, 2021
December 1, 2021
2.5 years
November 18, 2021
December 1, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
4 weeks
Study Arms (4)
group A
EXPERIMENTALdiclofenac sodium phonophoresis using continuous ultrasound with a frequency of 1MHz, an intensity of 1.5W/Cm2 for 4 minutes
group B
EXPERIMENTALdiclofenac 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
EXPERIMENTALdiclofenac 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
EXPERIMENTALexercises only in form of (strengthening, stretching and occupational exercises).
Interventions
Eligibility Criteria
You may qualify if:
- Both sexes will be involved
- Duration of the disease is more than 12 weeks.
- Patient's age ranges from 20 to 40 years
You may not qualify if:
- Diabetic patients.
- Hypertension patients.
- Pregnant women
- Cardiovascular patients
- Patients with malunion fractures
- Patients with cervical Radiclopathy
- Patients with olecranon bursitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Emad MOHAMED
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 18, 2021
First Posted
December 15, 2021
Study Start
May 15, 2020
Primary Completion
November 1, 2022
Study Completion
November 1, 2022
Last Updated
December 15, 2021
Record last verified: 2021-12