Comparative Study Between Different Duty Cycles of Ultrasound Diclofenac Phonophoresis

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

Study Overview

• Status: Recruiting
• Conditions: Undefined
• Intervention / Treatment: Other: phonophoresis; Other: exercises

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 Type: Interventional
• Enrollment (Anticipated): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Emad MOHAMED
    • Contact: Emad MOHAMED; Phone Number: 01146808839; Email: Omdamohamed9111@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Both sexes will be involved
2. Duration of the disease is more than 12 weeks.
3. Patient's age ranges from 20 to 40 years

Exclusion Criteria:

1. Diabetic patients.
2. Hypertension patients.
3. Pregnant women
4. Cardiovascular patients
5. Patients with malunion fractures
6. Patients with cervical Radiclopathy
7. Patients with olecranon bursitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: group A; diclofenac sodium phonophoresis using continuous ultrasound with a frequency of 1MHz, an intensity of 1.5W/Cm2 for 4 minutes	Other: phonophoresis; treatment
EXPERIMENTAL: group B; 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	Other: phonophoresis; treatment
EXPERIMENTAL: group C; 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	Other: phonophoresis; treatment
EXPERIMENTAL: group D; exercises only in form of (strengthening, stretching and occupational exercises).	Other: exercises; treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 15, 2020
• Primary Completion (ANTICIPATED): November 1, 2022
• Study Completion (ANTICIPATED): November 1, 2022

Study Registration Dates

• First Submitted: November 18, 2021
• First Submitted That Met QC Criteria: December 1, 2021
• First Posted (ACTUAL): December 15, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 15, 2021
• Last Update Submitted That Met QC Criteria: December 1, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 6786

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No