Protocol summary

Study aim
Determining and comparing the effectiveness of two treatment methods, dry needling and kinesiotaping,in the treatment of tennis elbow
Design
Clinical trial,with parallel groups,double-blind,randomized,on 62 patients.SPSS version 22 software was used for randomization
Settings and conduct
At the physical medicine clinic;Acupuncture method:one needle in the lateral epicondyle and at the point of maximum pain.Kinesio taping method:A Y strip with a width of 5 cm from a place one cm above the external epicondyle to the distal side so that the extensor muscles are placed between the two adhesive arms. An I-shaped band with a width of 5 cm and a length of 10 cm from medial to lateral forearm with moderate tension.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age 30 to 65 years; Pain in the lateral epicondyle for at least a month; Pain in cozen's test; Pain in the Maudsley's test; Supination resistance test Exclusion criteria: diabetes mellitus; cervical radiculopathy; neuropathy; arthritis in the upper limb or history of arthritis; history of forearm and elbow surgery; Acute elbow trauma; allergy to Kinesiology tape; Cubital tunnel syndrome; carpal tunnel syndrome; rotator cuff tendonitis؛ fibromyalgia syndrome; ipsilateral internal epicondylitis
Intervention groups
The first group was treated with dry needling and exercise and a non-steroidal anti-inflammatory drug(NSAID)(Meloxicam 15 mg daily) for three weeks.The second group was treated with kinesiotyping and exercise and a NSAID for three weeks.Home sports include stretching exercises, eccentric strengthening exercises and joint range of motion.Evaluation of pain intensity using Visual Analogue Scale (VAS) criterion.Evaluation of the functional status with the The Patient-Rated Tennis Elbow Evaluation (PRTEE)
Main outcome variables
pain score based on VAS criteria;pain score based on PRTEE criteria

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230722058889N1
Registration date: 2023-09-23, 1402/07/01
Registration timing: registered_while_recruiting

Last update: 2023-09-23, 1402/07/01
Update count: 0
Registration date
2023-09-23, 1402/07/01
Registrant information
Name
zahra eshaghian dorcheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3376 2229
Email address
mozr88@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-11, 1402/05/20
Expected recruitment end date
2024-11-10, 1403/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effectiveness of two treatment methods, dry needling and kinesiotaping, in the treatment of tennis elbow
Public title
A comparative study of the effectiveness of two treatment methods, dry needling and kinesiotaping, in the treatment of tennis elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30 to 65 years Pain in the lateral epicondyle for at least a month Pain in cozen's test Pain in the extensor carpi radialis test (that is, resistance to the extension of the middle finger - Maudsley's test) Supination resistance test (Mill's test)
Exclusion criteria:
Diabetes Mellitus Cervical radiculopathy Bilateral lateral epicondylitis neuropathy Arthritis in the upper limb or a history of arthritis Bilateral lateral epicondylitis pregnancy History of forearm and elbow surgery Acute elbow trauma Allergy to Kinesiology tape Cubital tunnel syndrome Carpal tunnel syndrome autoimmune disease Rotator cuff tendonitis Local or systemic upper limb infection Fibromyalgia syndrome Medial epicondylitis of the same side An old fracture in the damaged arm Changing the shape of the elbow Coagulation diseases
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Data analyser
Sample size
Target sample size: 62
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple way, individual randomization unit and using statistical software.
Blinding (investigator's opinion)
Double blinded
Blinding description
Allocation of patients to two treatment groups is done randomly using spss version 22 software.The blinding is two-way, and the main implementer of the design and the data analyzer are not aware of the order of placing people in the clinical groups.
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
Al-Zahra Hospital, Sefe Blvd, Aghareb parast highway.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Approval date
2023-06-26, 1402/04/05
Ethics committee reference number
IR.MUI.MED.REC.1402.127

Health conditions studied

1

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

Primary outcomes

1

Description
Pain score
Timepoint
Before performing the treatment methods and in the 3rd and 8th weeks after the treatment
Method of measurement
Visual Analogue Scale

2

Description
Functional status
Timepoint
Before performing the treatment methods and in the 3rd and 8th weeks after the treatment
Method of measurement
Patient Rating Forearm Evaluation Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Dry needling method:The first group is treated with dry needling and exercise and a non-steroidal anti-inflammatory drug (Meloxicam 15 mg daily) for three weeks. The position is neutral. After cleaning the skin with 70% isopropyl alcohol, a needle with a size of 0.25 x 25 in the lateral epicondyle and at the point of maximum pain using the Hong fast-in-fast-out method 20 times in a specific place It is moved for 20 seconds and the Chou technique is also used to facilitate the movement of the needle by rotating at the same time when inserting and removing the needle. This work is done twice a week for 3 weeks and a total of 6 sessions.
Category
Treatment - Devices

2

Description
Intervention group: Kinesio taping:The second group is treated with kinesio taping and exercise and a non-steroidal anti-inflammatory drug (Meloxicam 15 mg daily) for three weeks. We glue near the end of the muscles so that the volume of the extensor carpi radialis brevis, extensor carpi radialis longus, and extensor carpi ulnaris muscles is placed between the two arms of the glue. The beginning and end of the glue is done without tension and the middle of the glue is done with medium tension, which works with a restraining mechanism.Then we stick an I-shaped strip with a width of 5 cm and a length of 10 cm on the outer part of the elbow so that the middle stretch part of the adhesive is placed on the point of the most pain and the two sides of the adhesive are without tension, which can be removed with the space correction mechanism. Weight is applied. Then, an I-shaped band with a width of 5 cm and a length of 10 cm is attached with a medium tension from the inside of the elbow to the outside in the anatomical position of the body while the muscle is pushed outward with the fascia correction technique. During these procedures, the patient's elbow is in extension, and the wrist is in pronation, flexion, and ulnar deviation. This work is done twice a week for 3 weeks and a total of 6 sessions.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Hospital
Full name of responsible person
Razieh Maghruri
Street address
Al-Zahra Hospital,Sefe Blvd, Aghareb Parast Highway,
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
alzahra@mui.ac.ir

2

Recruitment center
Name of recruitment center
Amin Hospital
Full name of responsible person
Razieh Maghruri
Street address
Amin Medical Education Center,Ibn Sina St, Shahada Square.
City
Isfahan
Province
Isfehan
Postal code
۸۱۴۸۶۵۳۱۴۱
Phone
+98 31 3112 2020
Email
amin@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Gholamreza Asgari
Street address
Isfahan University of Medical Sciences, Hezar Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 3060
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Razieh Maghruri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Al-Zahra Hospital, Sefe Blvd., Aghareb Parast Highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
ramaghroori@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Razieh Maghruri
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Al-Zahra Hospital, Sefe Blvd., Aghareb Parast Highway
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 5555
Email
ramaghroori@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Eshaghian dorcheh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No 252, Shahid Dr.Beheshti street, Dorcheh Town
City
Isfahan
Province
Isfehan
Postal code
8431847963
Phone
+98 31 3376 2229
Fax
Email
mozr88@yahoo.com

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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
There are no other conditions.
From where data/document is obtainable
Send the request to mozr88@yahoo.com.
What processes are involved for a request to access data/document
After 1 month, the documents or data files will reach her or him.
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