Ozonated Gel Phonophoresis On Chronic Lateral Epicondylitis

NCT05872165 | Unknown

• 1 other identifier: University of cairo PHT
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Epicondylitis

Outcome Measures

Primary Outcomes (3)

• 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

• wrist ROM

  Measurment of wrist range of motion using universal goniometer

  4 weeks

• Hand grip strength

  measurment of hand grip strength using hand grip dynamometer

  4 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Device: phonophoresis; Other: conventional physical therapy

Control group

OTHER

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

Other: conventional physical therapy

Interventions

phonophoresis DEVICE

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

Also known as: Ultrasound with ozonated medium gel

Experimental group

conventional physical therapy 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.

Also known as: Tens and exercises

Control group; Experimental group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Interventions

Phonophoresis; Ultrasonography; Transcutaneous Electric Nerve Stimulation; Exercise

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physical therapist

Study Record Dates

• First Submitted: May 12, 2023
• First Posted: May 24, 2023
• Study Start: June 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: September 1, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share