Ozonated Gel Phonophoresis On Chronic Lateral Epicondylitis

NCT ID: NCT05872165

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2023-09-01

Brief Summary

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

Detailed 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.

Conditions

Epicondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

this group of 20 subjects will receive the ozonated media phonophoresis plus conventional physical therapy program 3 times weekly for 4 weeks.

Group Type: EXPERIMENTAL

phonophoresis

Intervention Type: DEVICE

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

conventional physical therapy

Intervention Type: OTHER

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.

Control group

this group of 20 subjects will receive only conventional physical therapy program 3 times weekly for 4 weeks.

Group Type: OTHER

conventional physical therapy

Intervention Type: OTHER

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.

Interventions

phonophoresis

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

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Other Intervention Names

Ultrasound with ozonated medium gel; Tens and exercises

Eligibility Criteria

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Abd Elaziz Mohamed Hefny

physical therapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

University of cairo PHT

Identifier Type: -

Identifier Source: org_study_id