In this triple blind (patient, therapist, assessor), clinical randomized trial (phase 3) we aim to investigate the effect of 10 sessions of continuous and pulsed ultrasound application in comparison to sham ultrasound (on device without output). Subjects suffering from lateral epicondylitis for more than 3 months (60 patients from one university hospital), aged between 18 and 65, will be randomly allocated to 3 groups using sealed envelopes.
All groups will receive ultrasound (real or sham; continuous ultrasound: 3 MHz, 1 watt/cm 2, pulse ultrasound: 3 MHZ, 1.7 watt/cm 2) 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) questionnaire) will be measured before and after treatment as well as in 2 months follow up.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016020121139N3
Registration date:2016-05-18, 1395/02/29
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-05-18, 1395/02/29
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
2016-05-21, 1395/03/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pulse and continuous ultrasound therapy on pain and function of patients with lateral epicondylitis
Public title
The effect of ultrasound waves on Tennis elbow
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Having lateral epicondylitis for more than 3 months
2. No history of surgery or fracture in upper extremity or spine
3. Not having any systemic disease
4. Have not received physiotherapy treatment of any kind during last 6 months
5. Not pregnant
6. Not having psychological problems or not using any medicine related to psychological problems
Exclusion Criteria:
1. Patient not willing to continue treatment
2. Violation of any one of inclusion criteria
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:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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, IRAN
City
Tehran
Postal code
Approval date
2015-12-04, 1394/09/13
Ethics committee reference number
IR.IUMS.REC 1394.8611215627
Health conditions studied
1
Description of health condition studied
Lateral epicondylitis
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis or Tennis elbow
Primary outcomes
1
Description
Pain
Timepoint
before treatment-after 10 sessions of treatment- in 2 months followup
Method of measurement
visual analog scale
Secondary outcomes
1
Description
function
Timepoint
before treatment -after 10 sessions of treatment- in 2months followup
Method of measurement
Disability of arm shoulder and hand questionnaire
Intervention groups
1
Description
first group
continuous ultrasound
3 mega hertz
1.5 watt/cm2
3minutes