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Clinical Trials/NCT05158985
NCT05158985UnknownNot Applicable

Comparative Study Between Different Duty Cycles of Ultrasound Diclofenac Phonophoresis in Management of Chronic Lateral Epicondylitis: Randomized Controlled Trial

October 6 University1 site in 1 country76 target enrollmentStarted: May 15, 2020Last updated:
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
76
Locations
1
Primary Endpoint
Visual analogue scale for pain intensity measurement

Study Overview

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

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • •Diabetic patients.
  • •Hypertension patients.
  • •Pregnant women
  • •Cardiovascular patients
  • •Patients with malunion fractures
  • •Patients with cervical Radiclopathy
  • •Patients with olecranon bursitis

Arms & Interventions

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

Intervention: phonophoresis (Other)

group A

Experimental

diclofenac sodium phonophoresis using continuous ultrasound with a frequency of 1MHz, an intensity of 1.5W/Cm2 for 4 minutes

Intervention: phonophoresis (Other)

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

Intervention: phonophoresis (Other)

group D

Experimental

exercises only in form of (strengthening, stretching and occupational exercises).

Intervention: exercises (Other)

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

basma osama

Principal Investigator

October 6 University

Study Sites (1)

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