The effect of high power laser with exercise versus sham high power laser with exercise versus high power laser on pain, grip strength and function in patients with chronic lateral epicondylitis.
To evaluate the effect of high power laser in lateral epicondylitis
Design
A randomized, double blinded, sham controlled clinical trial with 3 parallel groups of about 75 participants.
Settings and conduct
This study will be conducted in physiotherapy clinic of Iran Rehabilitation School. Participants will randomly assigned to 3 groups after filling out the consent and collecting information forms. Participants and the assessor will be blinded about the groups. Evaluation will be done before treatment and at the end of the first, fifth, tenth sessions and after 3 months follow up. Intervention in the all groups includes 1 warm up session and 10 treatment sessions every other day(3 per week). After 10 treatment sessions the data will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Pain at/around the lateral epicondylitis that exacerbates by gripping; age between 35 -55 years; symptoms duration between 3-6 months; 2 of 3 positive result of provocative tests comprising Mill`s, Maudsley`s and Cozen`s tests; tenderness on palpation of lateral epicondyle
Exclusion Criteria: cervical radiculopathy; neuropathy; myelopathy; any type of treatment for example: drugs; local injection and physiotherapy with in the past 3 months; upper limb surgery; deformity and fractures of elbow joint bones; pregnancy; rheumatic diseases and photo sensitivity
Intervention groups
The intervention group NO.1 will receive high power laser with exercise, the intervention group NO.2 will receive high power laser and the control group will receive sham high power laser with exercise and the effect of high power laser, high power laser with exercise and exercise on chronic lateral epicondylitis will be studied and compared.
Main outcome variables
The pain; hand grip and function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140810018754N10
Registration date:2019-11-29, 1398/09/08
Registration timing:registered_while_recruiting
Last update:2019-11-29, 1398/09/08
Update count:0
Registration date
2019-11-29, 1398/09/08
Registrant information
Name
Javad Sarrafzadeh
Name of organization / entity
Iran University of Medical Sciences, School of Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
00982122228051-00982122227124
Email address
sarrafzadeh.j@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-20, 1398/08/29
Expected recruitment end date
2020-05-19, 1399/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of high power laser with exercise versus sham high power laser with exercise versus high power laser on pain, grip strength and function in patients with chronic lateral epicondylitis.
Public title
The effect of high power laser in chronic lateral epicondylitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of the symptoms between 3 to 6 months
Exacerbating the pain on lateral aspect of elbow by gripping
2 of 3 positive results of Mills-Cozen and Maudsley tests
Tenderness with palpation of lateral epicondylitis
Exclusion criteria:
Cervical radiculopathy, neuropathy and myelopathy
Any type of treatment; drugs, local injections and physiotherapy within the past 3 months
History of upper extremity surgical treatment
Deformity and fractures of the humerus and elbow joint bones
Pregnancy
Rheumatic disease
Photosensitivity
Age
From 35 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Method: simple - unit: personal- by using sealed envelope
Participants will be randomly assigned to 3 groups(intervention NO1.; intervention NO2. and control groups) by drawing a sealed envelope in which the number of one of the groups is written from a box. After completing a group it`s envelope will be put away.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants will be unaware of classification and to prevent of the participants communication, timing will arrange carefully. In the control group, the Laser set will be off. Assessor will be kept unaware and will be asked to do just evaluation and abstrain of any answer and question.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Scienses
Street address
5th Floor, Iran University of Medical Science, next to Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2019-09-14, 1398/06/23
Ethics committee reference number
IR.IUMS.REC.1398.588
Health conditions studied
1
Description of health condition studied
Chronic Lateral Epicondylitis
ICD-10 code
M77.10
ICD-10 code description
Chronic Lateral Epicondylitis
Primary outcomes
1
Description
Pain
Timepoint
Before warm up session ,at the end of the first, fifth, tenth sessions and after 3 months
Method of measurement
VAS=visual analog scale
Secondary outcomes
1
Description
Hand grip strength
Timepoint
Before warm up session, at the end of first, fifth,tenth,sessions and after 3 months follow up
Method of measurement
Dynamometer
2
Description
Function
Timepoint
Before warm up session; at the end of first; fifth; tenth sessions and after 3 months follow up
In the intervention group NO.1, intervention includes high power laser therapy and exercise. The laser parameters are: power 7 W.; energy dose 10 j/cm2; duty cycle 50%. In the first session that is a warm up the laser dose will be 5 j/cm2 and in the next ten sessions the laser dose will be 10 j/cm2. Subjects will be evaluated before the warm up; at the end of the first; fifth; tenth sessions and after 3 months follow up. During the each session, in sitting position, elbow in extension and forearm in pronation after safety precautions the treatment area will be demarcated then the laser probe will be moved along the long axis and transverse to the tendon. Exercise includes static stretching followed by eccentric exercise of wrist extensors. Stretching exercise will be performed in seated position with elbow extension and forearm pronation and wrist flexion with ulnar deviation.Stretch force will be applied by therapist according to the participant tolerance for 30 to 45 seconds and 3 times before and 3 times after eccentric exercise with 30 seconds rest between each stretch. Eccentric exercise will be performed in the seated position with elbow extension, forearm pronation and maximum wrist extension. Then the participant slowly will lower the wrist in to the flexion for a count of 30. Using the contralateral hand to return to the started position. 3 set of 10 repetition will be performed during each session with a one minute rest interval between each set for 10 sessions every other day.
Category
Treatment - Other
2
Description
Intervention group NO.2:This group receives high power laser( with the protocol as mentioned in group NO.1( laser power 5W; laser dosage 5J/CM2 in the warm up session and 10J/cm2 in the 10 treatment sessions )without exercises. Due to ethical considerations subjects will be offered the exercise after 3 months follow up.
Category
Treatment - Other
3
Description
Control group: In this group the laser unit will be off and the exercise program will be performed as the program in the intervention group NO.1. Due to ethical considerations the subjects will be offered the true treatment after 3 month follow up.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
physiotherapy clinic of School of Rehabilitation Sciences, Iran University of Medical Sciences
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Sarrafzadeh Javad
Position
Associate Professore
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran St., Shahnazari St., Madar Squ., Mirdamad St.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Sarrafzadeh Javad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy department, School of Rehabilitation Sciences, Madadkaran St., Shahnazari St., Madar squ., Mirdamad St.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sarrafzadeh Javad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy department of Rehabilitation Sciences, Madadkaran St., Shahnazari St., Madar Squ., Mirdamad St.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 8051
Email
sarrafzadeh.j@iums.ac.ir
Web page address
http://rehab.iums.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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data or results of the present study will be presented in an article or some articles that will be published after completing the study.
When the data will become available and for how long
After completing the present study and publishing the resulting article or articles
To whom data/document is available
All researchers in the field of the present study
Under which criteria data/document could be used
With the same goal as the present study and with mention of the present study as the reference. All intellectual property rights of the present study belongs to the Iran University of Medical Sciences.
From where data/document is obtainable
The corresponding author of the article or articles derived from this study
What processes are involved for a request to access data/document
Written request from the author responsible for the present review after the publication of the resulting article or articles.