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Comparison effectiveness of microcurrent and exercise therapy on the pain and function in patients with Lateral Epicondylitis(Tennis Elbow disease)

Protocol summary

Study aim
Comparison effectiveness of microcurrent and exercise therapy on the pain and function in patients with Lateral Epicondylitis ,An unobserved clinical trial
Design
Sixty patients, are referred to the clinic with a physician specializing in hand approval with a diagnosis of Lateral Epicondylitis. The procedure will be explained to eligible patients, persons fills in the written consent.Each patient randomly selects an envelope containing the letter A or B, which represents the name of the intervention group.
Settings and conduct
Patients will initially be treated with a non-steroidal anti-inflammatory drug at the same dose and duration for initial pain relief. A group patients are exposed to 70 μA electrical current for 15 minutes per session for 6 weeks and 3 sessions per week. In B group, patients will undergo exercise therapy intervention for 6 weeks and 3 sessions per week under the supervision of a physician. (Researcher blinding - one blind)
Participants/Inclusion and exclusion criteria
Inclusion criteria:All people aged 18 to 60 years who are referred from Specialized in hand surgery to Mostafavian Clinic Sports Medicine Center with a clinical diagnosis of Lateral Epicondylitis. Criteria for non-inclusion:have any contraindications to the use of microcurrent therapy and or Any history of shoulder or elbow fractures or history of dislocations in these areas during the past year, Any history of shoulder and elbow surgery in the last six months, Any phobia about treatment and suffering from chronic psychiatric disorders, Any allergies and contraindications to taking NSAIDs, Any history of cervical discopathy confirmed by imaging and sensory-motor symptoms (paresthesia) in the upper extremities
Intervention groups
A.Microcurrent therapy Group B. Exercise therapy group This study has no control group.
Main outcome variables
Type of treatment, age, sex and occupation of the patient

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140708018409N3
Registration date: 2021-08-23, 1400/06/01
Registration timing: registered_while_recruiting

Last update: 2021-08-23, 1400/06/01
Update count: 0
Registration date
2021-08-23, 1400/06/01
Registrant information
Name
Gholamreza Partovi
Name of organization / entity
Mazandaran University of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 6552
Email address
ghpartovi@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-23, 1400/06/01
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison effectiveness of microcurrent and exercise therapy on the pain and function in patients with Lateral Epicondylitis(Tennis Elbow disease)
Public title
The effect of microcurrent device and exercise therapy in the treatment of patients with Tennis Elbow disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with Lateral Epicondylitis in the age range of 18 to 60 years who do not have criteria for not entering the interventions
Exclusion criteria:
Any contraindications to the use of microcurrent therapy, including: epilepsy, diabetes, immune system disorders, cancer, melanoma, metal implants (plates, pins, and screws) at the treatment site, open wounds, pacemaker, phlebitis, thrombosis , embolism, varicose veins and pregnancy Any history of shoulder or elbow fractures or history of dislocations in these areas during the past year Any history of shoulder and elbow surgery during the last six months Any phobias about treatment and suffer from chronic psychiatric disorders Any allergies and contraindications to the use of NSAIDs Any history of cervical discopathy confirmed by imaging and sensory-motor involvement symptoms (paresthesia) in the upper limb
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
There are two envelopes with names A and B, including microcurrent and exercise therapy group, inside the container and the patient chooses one. The selected envelope is then inserted into the container and the next patient selects one again
Blinding (investigator's opinion)
Single blinded
Blinding description
Considering that the patient knows in which group (exercise therapy or microcurrent therapy ) but the evaluator (supervisors) do not know which patient is in which group and all follow-ups are done by the sports medicine assistant and the evaluator only reviews the results It deals with questionnaires and recorded values of manual dynamometer, so this study is one-way blind.
Placebo
Not used
Assignment
Parallel
Other design features
Clinical trial without control group, with parallel groups, one-way blind, randomized

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Vice chancellor for research Mazandaran University of Medical Sciences, Moalem Square, Moalem Street
City
Sari
Province
Mazandaran
Postal code
4817844718
Approval date
2021-01-24, 1399/11/05
Ethics committee reference number
IR.MAZUMS.REC.1399.858

Health conditions studied

1

Description of health condition studied
Lateral Epicondylitis
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis

Primary outcomes

1

Description
Patient-Rated Tennis Elbow Evaluation questionnaire (PRTEE)
Timepoint
Before the beginning and end of the intervention (sixth week) and 12 weeks after the end of the intervention
Method of measurement
Measurements are performed based on the values obtained from PRTEE questionnaire

2

Description
Visual Analog Scale For Pain(VAS)
Timepoint
Before the beginning and end of the intervention (sixth week) and 12 weeks after the end of the intervention
Method of measurement
Measurements are performed based on the values obtained from VAS questionnaire

3

Description
Handheld dynamometer
Timepoint
Before the beginning and end of the intervention (sixth week) and 12 weeks after the end of the intervention
Method of measurement
Measurements are performed based on the values obtained from Handheld dynamometer .

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1:Exercise therapy:In this study, exercise therapy protocol was designed in a 6-week period of exercise to strengthen the elbow muscles focusing on the extensor muscles of the forearm involved in the pathology of lateral epicondylitis.Exercise sessions for 6 weeks 3 sessions per week according to the patient's tolerance based on the VAS scale are performed under the supervision of a sports medicine assistant at the clinic.Interventions including range of motion exercises, isometric, isotonic and eccentric exercises can be performed in three sets of 15 repetitions according to the patient's tolerance up to the experience of mild pain (4: VAS). Rest between sets will be 1-2 minutes.If the patient mentions debilitating pain (VAS: 8), the exercise is stopped and its intensity is recorded and it is performed with less intensity in the next sessions.When the patient reaches VAS: 0 in painless exercises, the intensity of the exercises is improved by using weights up to half a kilogram.Stretching exercises are performed in the form of static stretching performed by the patient him/herself with the support of the other hand. 6 stretches divided into 2 sets of 3 stretches are done at the beginning and end of exercise therapy with a time of 30 to 45 seconds of stretching and 30 seconds of rest between stretches.
Category
Treatment - Devices

2

Description
Intervention group 2: In this study,microcurrent interventionn by NU-TEK MT8000 COMBO STIMULATOR portable microcurrent device made in China for 6 weeks and 3 sessions of 15 minutes every week under 70 μA current at the origin of the extensor muscles in the external epicondyle of the hand will be done.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Mostafavian Clinic
Full name of responsible person
Dr Gholamreza Partovi
Street address
Razi 3
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 6552
Email
ghpartovi@mazums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr Majid Saeedi
Street address
Vice chancellor for research Mazandaran University of Medical Sciences, Moalem Square, Moalem Street
City
Sari
Province
Mazandaran
Postal code
4471848178
Phone
+98 11 3325 7230
Email
pajooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Gholamreza Partovi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Emam Khomeyni Hospital, Amir Mazandarani Ave
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 6552
Fax
+98 11 3336 3754
Email
ghpartovi@mazums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Gholamreza Partovi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Emam Khomeyni Hospital, Amir Mazandarani Ave
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 6552
Fax
+98 11 3336 3754
Email
ghpartovi@mazums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Gholamreza Partovi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Emam Khomeyni Hospital, Amir Mazandarani Ave
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3336 6552
Fax
+98 11 3336 3754
Email
ghpartovi@mazums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
results of statistical analysis and its analysis
When the data will become available and for how long
Start of access 12 months after printing results
To whom data/document is available
Health researchers
Under which criteria data/document could be used
view data
From where data/document is obtainable
corresponding author
What processes are involved for a request to access data/document
About 2 months
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