Protocol summary

Study aim
The purpose of our research is answer to this question: are shoulder and scapula muscles exersices plus local elbow exersice play a role on pain, strenght or disability in patients with lateral epicondylalgia? and to identify which patients may best benefit from this treatment approach; versus traditional physiotherapy ( heat, friction massage, TENS, local elbow exersice.)
Design
Randomised balance, 40 patients divided 2 gruops, blinded
Settings and conduct
patients that come to private clinics or Quaem hospital
Participants/Inclusion and exclusion criteria
age 18-65 years pain score at the lateral side of the elbow at least 3 from 10 pain in at least two of the following four tests, 1- Cozen's Test 2- Mill's Test 3- pain on the facet of the lateral epicondyle when palpated or presured 4- resisted handgriped thorasic surgery neurologic and orthopedic diseases in shoulder, elbow or wrist Congenital disorder in elbow elbow injection in 1 month ago physiotherapy in 3 month ago Myofascial trigger points with radicular pain in elbow
Intervention groups
1- Traditional physiotherapy group ( local exersice- IR- Heat- TENS) 2- New physiotherapy group (local elbow exersice- IR- Heat- TENS- shoulder and scapula exersice)
Main outcome variables
pain strenght function disability

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180720040532N1
Registration date: 2018-08-11, 1397/05/20
Registration timing: registered_while_recruiting

Last update: 2018-08-11, 1397/05/20
Update count: 0
Registration date
2018-08-11, 1397/05/20
Registrant information
Name
Akram Divandari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3382 2252
Email address
divandaria951@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-01, 1397/04/10
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of new physiotherapy with emphasis on shoulder and scapula exercises with traditional physiotherapy on pain, strength and disability outcomes in patients with lateral elbow tendinopathy
Public title
comparative effect of 2 physiotherapy methodes in patients with tennis elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age 18-65 years pain score at the lateral side of the elbow at least 3 from 10 pain in at least two of the following four tests, 1- Cozen's Test 2- Mill's Test 3- pain on the facet of the lateral epicondyle when palpated or presured 4- resisted handgriped
Exclusion criteria:
thorasic surgery neurologic and orthopedic diseases in shoulder, elbow or wrist Congenital disorder in elbow elbow injection in 1 month ago physiotherapy in 3 month ago Myofascial trigger points with radicular pain in elbow
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
we use pockets, we wrote methode of treatment in pockets and selected one of them.
Blinding (investigator's opinion)
Double blinded
Blinding description
patients don't know about 2 groups assessor doesn't know group's patient analysor doesn't know group's datas
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Azadi Squre
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.MUMS.REC.1397.091

Health conditions studied

1

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

Primary outcomes

1

Description
pain
Timepoint
pre- post
Method of measurement
Visual Analoge Scale

2

Description
strenght
Timepoint
pre- post
Method of measurement
handheld digital dynamometer

3

Description
function
Timepoint
pre-post
Method of measurement
Patient-related Tennis Elbow Evaluation Questionnaire

4

Description
disability
Timepoint
pre- post
Method of measurement
Disability Arm Shoulder Hand Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
control group: local elbow exersice
Category
Rehabilitation

2

Description
Intervention group: local elbow exersice+ scapula and shoulder exersice
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Qaem Hospital, Physiotherapy section
Full name of responsible person
Javad Zarandi
Street address
Ahmad-Abad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3840 0000
Fax
+98 51 3840 0000
Email
Quaem@mums.ac.ir
Web page address
https://www.quaem.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaqqodi
Street address
Doktora Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3841 2081
Fax
+98 51 3841 3006
Email
Presidentoffice@mums.ac.ir
Web page address
http://www.mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Neda Mostafaee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Azadi Squre
City
mashhad
Province
Razavi Khorasan
Postal code
13944-91388
Phone
+98 51 3884 6711
Fax
+98 51 3884 6711
Email
nada_mostafaee@yahoo.com
Web page address
http://www.mums.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Neda Mostafaee
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Azadi Squre
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 51 3884 6710
Fax
+98 51 3884 6728
Email
neda_mostafaee@yahoo.com
Web page address
http://www.mums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Akram Divandari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Azadi Squre
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948964
Phone
+98 21 3382 2252
Fax
+98 51 3884 6728
Email
divandaria951@mums.ac.ir
Web page address
http://www.mums.ac.ir

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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