Back to resultsOzonated Gel Phonophoresis On Chronic Lateral Epicondylitis
Primary Purpose
Epicondylitis
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
phonophoresis
conventional physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Epicondylitis
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Experimental group
Control group
Arm Description
this group of 20 subjects will receive the ozonated media phonophoresis plus conventional physical therapy program 3 times weekly for 4 weeks.
this group of 20 subjects will receive only conventional physical therapy program 3 times weekly for 4 weeks.
Outcomes
Primary Outcome Measures
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 .
wrist ROM
Measurment of wrist range of motion using universal goniometer
Hand grip strength
measurment of hand grip strength using hand grip dynamometer
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05872165
Brief Title
Ozonated Gel Phonophoresis On Chronic Lateral Epicondylitis
Official Title
Influence Of Ozonated Gel Phonophoresis In The Treatment Of Chronic Lateral Epicondylitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
September 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epicondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
this group of 20 subjects will receive the ozonated media phonophoresis plus conventional physical therapy program 3 times weekly for 4 weeks.
Arm Title
Control group
Arm Type
Other
Arm Description
this group of 20 subjects will receive only conventional physical therapy program 3 times weekly for 4 weeks.
Intervention Type
Device
Intervention Name(s)
phonophoresis
Other Intervention Name(s)
Ultrasound with ozonated medium gel
Intervention Description
1 MHz, 1 W/cm2continuous mode of ultrasound therapy for 5 min. using ozonated gel as a coupling medium
Intervention Type
Other
Intervention Name(s)
conventional physical therapy
Other Intervention Name(s)
Tens and exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain status
Description
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 .
Time Frame
4 weeks
Title
wrist ROM
Description
Measurment of wrist range of motion using universal goniometer
Time Frame
4 weeks
Title
Hand grip strength
Description
measurment of hand grip strength using hand grip dynamometer
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
think to share after request.
Learn more about this trial
Ozonated Gel Phonophoresis On Chronic Lateral Epicondylitis
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