Efficacy of electromyography and ultrasound biofeedback in the treatment of lateral epicondylitis
Design
This study is a phase 3 clinical trial in which 50 patients undergo rehabilitation in two independent groups of biofeedback and ultrasound. Randomization is done using envelopes seals and is done in a single blind manner. The person who measures the outcome of the intervention is not aware of the type of intervention.
Settings and conduct
This study was conducted in the physical and rehabilitation ward of Besat Hospital in Hamadan. The target group is patients with lateral epicondylitis who undergo biofeedback and ultrasound rehabilitation because of the severity of pain and disability and failure to respond to the Non-steroidal and anti-inflammatory drugs. this study, is single blind. The individual who measures the outcome of interventions is not aware of the type of interventions.
Participants/Inclusion and exclusion criteria
Participants of patients with lateral epicondylitis referred to Beadat Hospital in Hamadan who have not responded to at least one course of non-steroidal anti-inflammatory drugs with no history of trauma, history of surgery , injection or physiotherapy at past 6 mounts. .
Intervention groups
Patients undergo rehabilitation in two different ways: biofeedback or ultrasound
Main outcome variables
severity of pain and problems during patients' daily activities and to punching power
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151123025202N6
Registration date:2020-01-10, 1398/10/20
Registration timing:registered_while_recruiting
Last update:2020-01-10, 1398/10/20
Update count:0
Registration date
2020-01-10, 1398/10/20
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between ultrasound therapy and biofeedback therapy in treatment of lateral epicondylitis
Public title
Treatment of lateral epicondylitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Pain in the external part of the elbow in at least 2 of the 4 tests of local pressure, wrist resistance extension, middle finger resistance extension, 2- to 5-finger resistance extension.
Duration of symptoms for at least 6 weeks
Failure to respond to at least one course with non-steroidal anti-inflammatory drugs
Exclusion criteria:
History of trauma in elbow
Medical history of Surgery in elbow
Injections or physiotherapy of elbow at past 6 months
History of Steroid use over the past 3 months
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
For this purpose, we will use Sealed non-transparent envelopes. on 25 paper sheets of letter I meaning intervention and on 25 sheets of letter C means comparison. will be written. We mix the sheets together and place them in the envelopes and drawer of the table.. each time the patient is eligible, we randomly pull out one of the envelopes and open them according to the letter I or C written on the paper. They will be assigned to either intervention or comparison group, respectively. It should be noted that sampling will be non placement.
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 Hamadan University of Medical Science
Street address
Shahid Fahmideh Blv, Vice-Chancellor for Research and Technology of Hamedan, , Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838677
Approval date
2019-06-14, 1398/03/24
Ethics committee reference number
Ir.UMSHA.Rec.1398.234
Health conditions studied
1
Description of health condition studied
lateral epicondylitis
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis
Primary outcomes
1
Description
the power of painless hand punching
Timepoint
Before treatment, immediately after treatment and three months after treatment
Method of measurement
It will be measured using a dynamometer
2
Description
Restriction on hand, arm and shoulder use for daily, occupational, and social activities and hand, arm or shoulder pain score during working and activity
Timepoint
Before treatment, immediately after treatment and three months after treatment
Method of measurement
With Quick DASH questionnaire, VAS scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The biofeedback device is manufactured in Canada. The patients are treated with biofeedback for 5 sessions and 7 minutes each session. The procedure is that the electrodes are closed on the forearm extensor and flexor muscles according to the treatment protocol, and then a visual feedback is presented to the individual on the basis of computer equipment and the frequency range of the contraction waves. The muscles strengthened in this process are primarily Extensor Carpi Radialis Brevis - Physiopedia and then Flexor carpi radialis, Flexor digitorum superficialis and Supinator and flexor wrist muscles will be inhibited. The main result of this study is effect strength and endurance of wrist and Wrist extensors extensors in lateral epicondylitis.
Category
Rehabilitation
2
Description
control group: In the Ultrasound group, the SLE laser therapy, Ultrasound (1 and 3.3 MHz multiphase) and EIE Construction Electrotherapy in Poland will be used. This group will also be treated for 5 sessions and 7 minutes each session.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Lobat Majidi
Street address
Shahid Beheshti Blv
City
Hamedan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0020
Email
besat@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
dr Saeid Bashirian
Street address
Shahid Fahmide Ave
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
dr Lobat Majidi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Shahid Fahmideh Ave, School of medical Science
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0572
Email
lobat.majidi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology, MPH
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh Ave, Medical School
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0097
Fax
Email
a.moradi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Shahid Fahmideh Ave
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available