Different types of physical modalities ranging from TENS to Ultrasound are used in the treatment of lateral epicondylitis (LE).Diathermy may increase vascular circulation and change tissue temperature causing proved pain relief in different musculoskeletal problems. There is little evidence to support the use of diathermy in the treatment of LE. In this double blind (patient, assessor), clinical randomized trial we aim to investigate the effect of 10 sessions of continuous diathermy application (15 minutes each session) in comparison to sham diathermy (on device without output). Subjects suffering from LE for more than 3 months, aged between 18 and 65, will be randomly allocated to 2 groups using sealed envelopes. Both groups will receive diathermy (real or sham) 3 days per week plus specific stretching and strengthening exercises. Pain (using visual analogue scale) and upper extremity function (using Quick DASH) Disabilities of the Arm Shoulder and Hand) outcome measure) will be measured before and after treatment as well as in 2 months follow up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016042321139N4
Registration date:2016-05-12, 1395/02/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-12, 1395/02/23
Registrant information
Name
Safoora Ebadi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 175 7107
Email address
ebadi.s@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran University of Medical Sciences
Expected recruitment start date
2016-05-16, 1395/02/27
Expected recruitment end date
2016-09-01, 1395/06/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of continuous Diathermy on pain and function of patients suffering from lateral epicondylitis
Public title
The effect of Diathermy on Tennis elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:
1.having lateral epycondilitis for more than 3 months
2.no history of surgery in upper extremities or spine
3.no history of fracture in upper exterimities or spine
4.have not received physiotherapy during last 6 months
5.not pregnant
6.no obvious psychological problem or not using related medcine
Exclusion:
1.not willing to continue
2.not being able to tolerate the modality
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
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 Sciences
Street address
Iran University of Medical Sciences ,Shahid Hemmat Highway .Tehran,1449614535,IRAN
ِDisability of Arm Shoulder and Hand questionnaire
Intervention groups
1
Description
intervention:
continuous diathermy 15 minutes (increase intensity until patient feels mild warmth)
+ stretching and strengthening exercise for upper extremity
Category
Rehabilitation
2
Description
control:
sham diathermy (the device is on and positioned the same way as in intervention group with no out put for 15 minutes )
+ stretching and strengthening exercise for upper extremity exercise
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Firouzgar Hospital
Full name of responsible person
Dr. Safoora Ebadi
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St., Karim khane zand St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Iran University of Medical Sciences
Full name of responsible person
Dr. Javad Ali Musavi
Street address
Iran University of Medical Sciences ,Shahid Hemmat Highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences; Faculty of Medicine
Full name of responsible person
Dr. Safoora Ebadi
Position
Assistant Professor
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St., Karim khane zand St.
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
ebadi.s@iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical sciences, Faculty of Medicine
Full name of responsible person
Dr. Safoora Ebadi
Position
Assistant professor, PhD Pt
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St., Karim khane zand St.
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
ebadi.s@iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical sciences
Full name of responsible person
Dr. Safoora Ebadi
Position
Assistant professor, PhD pt
Other areas of specialty/work
Street address
Physical Medicine and Rehabilitation Department, Firouzgar Hospital, Behafarin St., Karim khane zand St.
City
Tehran
Postal code
00982182141229
Phone
+98 21 8214 1229
Fax
Email
ebadi.s@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)