Ozonated Gel Phonophoresis On Chronic Lateral Epicondylitis

Epicondylitis Clinical Trial

Official title:

Influence Of Ozonated Gel Phonophoresis In The Treatment Of Chronic Lateral Epicondylitis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05872165
• Other study ID #: University of cairo PHT
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: May 2023
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Comparison between 2 groups of chronic lateral epicondylitis, to determine the effect of ozonated media phonophoresis on chronic lateral epicondylitis.

Description:

40 patients (male and female), patients age would be ranged from 30 to 50 years, would be randomly allocated using sealed envelope into randomly two matched group (A and B), Group A (Experimental): 20 patients would receive ultrasonic with ozonated gel as a coupling medium (phonophoresis) (1 MHz, 1 W/cm2continuous mode) for 5 min. plus, conventional physical therapy program consists of (conventional TENS (100 Hz) for 30 min - hot pack for 20 min- stretching and strengthening exercises, wrist rest splints). 3 times per week for 4 weeks.

Group B (control):20 patients will receive conventional physical therapy program consists of (conventional TENS (100 Hz) for 30 min - hot pack for 20 min- stretching and strengthening exercises, wrist rest splints) 3times per week for 4 weeks.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: September 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• All patients would be diagnosed as chronic lateral epicondylitis from both genders.

• Patients with chronic lateral epicondylitis that diagnosed by orthopedist.

• Positive clinical manifestation in all patients.

• Pain onset is more than 3 months.

• All participants must be medically stable and not be treated with analgesics or any medication which may cause misleading results.

• All patients had body mass index between 18.5 and 29.9 kg/m2.

Exclusion Criteria:

• Subjects would be excluded if they have:

Received intra articular injection from duration less than 3 months.

• Elbow instability.

• History of cancer.

• Pregnancy

• Infection.

• Skin diseases on elbow area.

• Open wound in elbow.

• Shoulder or elbow fractures

• Systemic diseases such as rheumatoid arthritis, Reiter's syndrome, or diabetes.

• Neurological diseases.

• Severe medical or psychiatric disorders.

• Elbow surgery.

• Entrapment of the radial nerve.

• Arthritis and effusion of the elbow.

Related Conditions & MeSH terms

• Epicondylitis
• Tennis Elbow

Intervention

Device:
• phonophoresis
1 MHz, 1 W/cm2continuous mode of ultrasound therapy for 5 min. using ozonated gel as a coupling medium

Other:
• conventional physical therapy
conventional TENS (100 Hz) for 30 min - hot pack for 20 min- stretching and strengthening exercises, wrist rest splints 3times per week for 4 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain status	assessment of pain using (visual analogue scale)s a horizontal line, 100 mm in length, anchored by word descriptors at each end. 2) The patient mark millimeters ed on the line the point that they feel ed represents their perception of their current state. The VAS score is determined by measuring in from the start point of the line to the point that the patient marks It was used to evaluate pain intensity. The VAS is a self. reported pain meas urement scale. The extremes of the line are labelled as no pain and worst pain. Each subject was asked to mark the point on the line that exactly corresponded to his/her pain .	4 weeks
Primary	wrist ROM	Measurment of wrist range of motion using universal goniometer	4 weeks
Primary	Hand grip strength	measurment of hand grip strength using hand grip dynamometer	4 weeks