Protocol summary

Study aim
The effect of Mulligan mobilization as an adjuvant therapy to extensor muscle dry needling of the wrist on the thickness of extensor carpi radialis brevis tendon, pain and upper extremity function in patients with lateral epicondylitis of the elbow
Design
The clinical trial with control and parallel-group, simple randomized,with 34 participants
Settings and conduct
Patients with tennis elbow affiliated to Semnan University of Medical Sciences will randomly be assigned to two groups: dry needling, dry needling with Mulligan. Upper extremity functional index by DASH questionnaire, grip strength with a Pneumatic squeeze bulb dynamometer, pain with VAS, and tendon thickness of extensor Carpi Radialis Brevis with ultra-sonography will be assessed. All evaluations will be done, before, after three treatment sessions and 10 days after
Participants/Inclusion and exclusion criteria
Inclusion Criteria؛ 1. Age between18 to 35 years 2. Confirmation of Tennis elbow Involvement by performing specialized tests 3. VAS greater than 4 Exclusion criteria ؛ 1- past epicondyle surgery 2-Cervical radiculopathy 3-Past injections (such as corticosteroid, self-blood, PRP, mesotherapy) 4- Acute complication
Intervention groups
First intervention group؛mulligan+ dry needling that, In addition to dry needling, the Mulligan technique will be done in the extension of elbow and pronation of forearm with 5-10 sec gentle glide in 3 sets of 10 repetitions. simultaneously taping of the extensor muscle group will be done to maintain normal radius alignment. The control group؛dry needling that the patient in supine or sitting, forearm in mid-position, the sterile needle at 0.25 * 0.25 mm inserted in lateral epicondyle trigger points of the elbow with 3 to 4 times rotation for 10 minutes.
Main outcome variables
Upper extremity function؛ The power of grip؛ pain ؛The thickness of extensor Carpi Radialis Brevis tendon

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190416043289N1
Registration date: 2020-01-11, 1398/10/21
Registration timing: prospective

Last update: 2020-01-11, 1398/10/21
Update count: 0
Registration date
2020-01-11, 1398/10/21
Registrant information
Name
MARZIEH MORTEZANEJAD
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3334 0867
Email address
mariptma62@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-04-20, 1399/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study on the effect of extensor muscles dry needling of the wrist with Mulligan mobilization technique on the thickness of extensor carpi radialis brevis tendon, pain and upper extremity function in patients with lateral elbow epicondylitis
Public title
Study on the effect of dry needling and Mobilization on the Pain of the lateral part of the elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both sexes: male and female, ages 18 to 35 years old Confirmation of tennis elbow by specialized tests VAS greater than 4
Exclusion criteria:
Surgery of the external epicondyle area Cervical Radiculopathy Past injections (eg, corticosteroid, self-blood, PRP, mesotherapy) Acute phase
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 34
Randomization (investigator's opinion)
Randomized
Randomization description
simple and single randomization, The random numbers table such that each person is given a code. The numbers will written in a table, and we select one place from the table in a blinded manner, then we select 17 numbers smaller than the selected number in the same row. The same would be true for the control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical sciences
Street address
Headquarters of the University of Medical Sciences,Basij Blvd,Semnan
City
Semnan
Province
Semnan
Postal code
35198-99951
Approval date
2019-11-26, 1398/09/05
Ethics committee reference number
IR.SEMUMS.REC.1398.207

Health conditions studied

1

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

Primary outcomes

1

Description
The thickness of extensor carpi radialis brevis tendon
Timepoint
The before of intervention, immediately and 10 days after the end intervention
Method of measurement
Ultrasonigraphy setting

2

Description
Upper exteremity function
Timepoint
Before of intervention, immediately and 10 days after the end intervention
Method of measurement
DASH questionnaire

3

Description
Grip power
Timepoint
Before of intervention, immediately and 10 days after the end intervention
Method of measurement
Pneumatic bulb dynamometer

4

Description
Pain
Timepoint
Before of intervention, immediately and 10 days after the end intervention
Method of measurement
Visual analogue scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Dry needling with Mulligan Mobilization that the patient in the supine or sitting position, forearm in mid-position, and the 25 * 0.25 mm sterile needle inserted in the trigger points of lateral epicondyle of the elbow with 3 to 4 rotations for 10 minutes. in addition to dry needling, the mulligan technique will be performed with a 5–10-sec gentle glide in extension of elbow and pronation of the forearm. simultaneously taping will apply to maintain normal radius alignment at the extensor muscle group. This technique will be done in 3 sets of 10 repetitions.
Category
Treatment - Devices

2

Description
Control group:Dry needling that the patient in the supine or sitting position, forearm in mid-position, and the 25 * 0.25 mm sterile needle inserted in the trigger points of lateral epicondyle of the elbow with 3 to 4 rotations for 10 minutes.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences
Full name of responsible person
Maedeh Sameae
Street address
Tabatabaee Clinic,Ghods Blvd, Mashahir Square
City
Semnan
Province
Semnan
Postal code
35196-18375
Phone
+98 23 3332 8502
Email
samieimaede@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Kookhaee
Street address
Semnan University of Medical Sciences,Basij Blvd,Semnan
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3344 8998
Fax
+98 23 3344 8999
Email
info@semums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Marzieh Mortezanejad
Position
Research Expert
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Tabatabaee Clinic,Ghods Blvd,Mashahir Square
City
Semnan
Province
Semnan
Postal code
3519618375
Phone
+98 23 3332 8502
Email
mmortezanejad98@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Atefeh Aminianfar
Position
Member of Faculty
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tabatabaee Clinic,Ghods Blvd, Mashahir Square
City
Semnan
Province
Semnan
Postal code
3519618375
Phone
+98 23 3332 8502
Email
aminfar83@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Marzieh Mortezanejad
Position
Research expert
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Tabatabaee Clinic, Ghods Blvd,Mashahir Square
City
Semnan
Province
Semnan
Postal code
3519618375
Phone
+98 23 3332 8502
Email
mmortezanejad98@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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