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Evaluation of TECAR therapy on the improvement of symptoms and function of patients with lateral epicondylitis

Protocol summary

Study aim
Determining of TECAR therapy on the improvement of symptoms and function of patients with lateral epicondylitis
Design
The randomized, Single-blind clinical trial, with the parallel groups, Phase 3 on 46 patients
Settings and conduct
In this randomized Single-blind clinical trial study, 46 eligible patients referred to physical medicine and rehabilitation clinic of Al-Zahra Hospital in Isfahan will be included in the study and randomly divided into two groups. Patients in the first group will be prescribed meloxicam and TECAR therapy and the second group will be given only meloxicam. Then their pain scores and performance will be compared between the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include diagnosis of lateral epicondylitis, lateral epicondylitis pain that lasts for at least 1 month, age category 18-65 years, and satisfaction to participate in the study. Exclusion criteria include having history of inflammatory joint disease, having history of affected elbow surgery, injection or physiotherapy of the affected elbow in the last 6 months, having history of trauma and elbow injury, existence of diseases that mimic the symptoms of lateral epicondylitis, and contraindications to TECAR devise(pregnancy, pacemaker, insulin pump, hearing aid, thrombophlebitis, growth plate, cancer, open wounds and skin lesions, skin allergies, fever and infection, lack of heat and heart disease).
Intervention groups
Intervention group: Patients in this group undergo TECAR therapy for 5 sessions, 3 days a week. In addition, meloxicam 15 mg is prescribed for two weeks. The use of brace (Cock-up) is also prescribed during treatment. Control group: For patients in this group, meloxicam 15 mg is prescribed for two weeks. The use of brace (Cock-up) is also prescribed during treatment.
Main outcome variables
Pain scores; Performance of arm, shoulder and hand(DASH)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220115053718N1
Registration date: 2022-01-21, 1400/11/01
Registration timing: registered_while_recruiting

Last update: 2022-01-21, 1400/11/01
Update count: 0
Registration date
2022-01-21, 1400/11/01
Registrant information
Name
Sahar Arzaghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3833 5910
Email address
sahar.arzaghi@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-01-21, 1400/11/01
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of TECAR therapy on the improvement of symptoms and function of patients with lateral epicondylitis
Public title
Effect of TECAR therapy on the improvement of symptoms and function of patients with lateral epicondylitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of lateral epicondylitis by a physical medicine and rehabilitation specialist with physical examination Lateral epicondylitis pain that lasts for at least 1 month Age category 18-65 years Satisfaction to participate in the study
Exclusion criteria:
Having history of inflammatory joint disease Having history of affected elbow surgery, injection or physiotherapy of the affected elbow in the last 6 months Having history of trauma and elbow injury Existence of diseases that mimic the symptoms of lateral epicondylitis Contraindications to pregnancy (pregnancy, pacemaker, insulin pump, hearing aid, thrombophlebitis, growth plate, cancer, open wounds and skin lesions, skin allergies, fever and infection, lack of heat and heart disease)
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 46
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 46 eligible patients are randomly selected. For this, the letter A is written on 23 sheets, and the letter B is written on 23 sheets, and each of them is placed in an envelope. Each patient is then asked to choose one of the envelopes. Depending on the selected envelope, the patient is assigned to one of two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Due to the different nature of the intervention in the two groups, the researcher and the patient are aware of the type of intervention, but the outcome assessor, data collector and statistical analyst will not be aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Street address Isfahan University of Medical Sciences, Hezar Jarib Ave., Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2021-12-24, 1400/10/03
Ethics committee reference number
IR.MUI.MED.REC.1400.705

Health conditions studied

1

Description of health condition studied
Lateral epicondylitis
ICD-10 code
M77.0
ICD-10 code description
Medial epicondylitis

Primary outcomes

1

Description
Pain
Timepoint
Before treatment, immediately and 1 month after the end of treatment
Method of measurement
Visual Analogue Scale(VAS)

2

Description
The Disabilities of arm, shoulder and hand Score
Timepoint
Before treatment, immediately and 1 month after the end of treatment
Method of measurement
The Disabilities of the Arm, Shoulder and Hand questionnaire(DASH)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in this group undergo TECAR therapy for 5 sessions, 3 days a week (every other day for 2 weeks). In addition, meloxicam 15 mg is prescribed for two weeks. The use of brace (Cock-up) is also prescribed during treatment.
Category
Treatment - Devices

2

Description
Control group: For patients in this group, meloxicam 15 mg is prescribed for two weeks. The use of brace (Cock-up) is also prescribed during treatment.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Parisa Taheri
Street address
Soffe Blvd, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Prs_taheri@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash Dastjerdi
Street address
Vice Chancellor for Research, School of Medicine, Hezar Jarib Street, Isfahan.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Taheri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Al-Zahra Hospital, Department of Physical Medicine and Rehabilitation
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Prs_taheri@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Taheri
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Al-Zahra Hospital, Department of Physical Medicine and Rehabilitation
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Prs_taheri@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Taheri
Position
Non-faculty specialist physician
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Al-Zahra Hospital, Department of Physical Medicine and Rehabilitation
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
Sahar.arzaghi1@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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