This double blind (exercise instructor and assessor) randomized clinical trial will be performed on seventy, 18 to 45,otherwise healthy subjects undergoing ACL reconstruction surgery after knee trauma . After surgery, patients will be randomly divided into two groups (receiving specific strengthening and stretching exercises for the knee plus TENS (100 hz, 100 microsecond,35-40 minutes) or only exercise for two weeks) using sealed envelopes. . International Knee Documentation Committee (IKDC) questionnaire, range of motion ( using goniometer) and VAS score will be evaluated for all patients after surgery (before rehabilitation program), after 2 and after 8-10 weeks from surgery to explore the possible additional effect of TENS on outcomes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051521139N5
Registration date:2016-06-04, 1395/03/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-06-04, 1395/03/15
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
2016-06-04, 1395/03/15
Expected recruitment end date
2016-10-20, 1395/07/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Does TENS help improve pain and function in the first phase of post ACL reconstruction rehabilitation?
Public title
The effect of TENS in the first phase of rehabilitation after ACL reconstruction surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
• Age: 18-45
• Having knee trauma
• Meet the criteria for ACL reconstruction surgery
• Not pregnant
• No history of previous surgery in spine or lower extrimities
• No psychological problems
• No systemic disease
Exclusion criteria:
• Not willing to continue
• Not being able to tolerate the intervention
• Violation of any one of inclusion criterias
Age
From 18 years old to 45 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double 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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences ,Shahid Hemmat Highway .Tehran,1449614535,IRAN
City
Tehran
Postal code
1449614535
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
IR.IUMS.REC 1394.871410001
Health conditions studied
1
Description of health condition studied
anterior cruciate ligament lesion
ICD-10 code
S83.5
ICD-10 code description
Sprain and strain involving (anterior)(posterior) cruciate ligament of knee
Primary outcomes
1
Description
Pain
Timepoint
before treatment-after 12 sessions of treatment- in 2 months followup
Method of measurement
visual analog scale
Secondary outcomes
1
Description
function
Timepoint
before treatment -after 12 sessions of treatment- in 2months followup
Method of measurement
International Knee Documentation Committee (IKDC) questionnaire
Intervention groups
1
Description
intervention:
specific strengthening and stretching exercises for knee plus
TENS : 100 hz, 100 microsecond,35-40 minutes ,12 sessions (2 weeks)
Category
Rehabilitation
2
Description
control:
specific strengthening and stretching exercises for knee for 2 weeks
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 .Tehran,1449614535,IRAN
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; e_safoora@hotmail.com
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
Phone
+98 21 8214 1229
Fax
Email
ebadi.s@iums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)