Investigating the effect of quadriceps neuromuscular electrical stimulation on pain scores, functional tests and quality of life of military personnel with partial anterior cruciate ligament tears
The effect of quadriceps neuromuscular electrical stimulation on pain scores, functional tests and quality of life in military personnel with partial anterior cruciate ligament tears
Design
Clinical trial with control group, with parallel groups, without blinding, randomized, phase 2 on 60 patients. Random blocks were used for randomization.
Settings and conduct
The non-blinded and randomized study will be conducted in the physical medicine clinic of Baqiyatullah Hospital. Sixty patients with partial rupture of the anterior cruciate ligament are included in the study, who are equally divided (30 people in each group) into intervention group of electrical nerve stimulation and the control group with routine treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: partial tear of the anterior cruciate ligament of the knee, membership in military operational departments.
Exlusion criteria: receiving physiotherapy 6 months ago, previous injury or history of surgery, history of chronic ankle instability.
Intervention groups
Intervention group: Quadriceps neuromuscular electrical stimulation;
Control group: Without quadriceps neuromuscular electrical stimulation.
Main outcome variables
Pain, quality of life, walking speed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231010059687N1
Registration date:2023-11-08, 1402/08/17
Registration timing:prospective
Last update:2023-11-08, 1402/08/17
Update count:0
Registration date
2023-11-08, 1402/08/17
Registrant information
Name
Arman Mahmodi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 81261
Email address
stu.armnmhmd@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-21, 1402/08/30
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of quadriceps neuromuscular electrical stimulation on pain scores, functional tests and quality of life of military personnel with partial anterior cruciate ligament tears
Public title
Electrical neuromuscular stimulation of the quadriceps in subjects with partial anterior cruciate ligament tears
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Partial tear of the anterior cruciate ligament of the knee
Membership in military operational departments
Exclusion criteria:
Received physiotherapy 6 months ago
Previous injury or history of surgery
History of chronic ankle instability
Age
From 18 years old to 40 years old
Gender
Male
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to two intervention groups using randomized block method. For this purpose, blocks of size four are prepared, the name of the intervention is written on two sheets and the name of the comparison is written on the two other sheets. The sheets are piled up and placed in the container, and one sheet is pulled out for each patient without placing it. Then four sheets are returned to the container and this process is repeated until the sample volume is reached.
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 Baqiyatallah Hospital
Street address
Vanak sq
City
Tehran
Province
Tehran
Postal code
1435916471
Approval date
2023-10-02, 1402/07/10
Ethics committee reference number
IR.BMSU.BAQ.REC.1402.074
Health conditions studied
1
Description of health condition studied
Cruciate ligament tears
ICD-10 code
S83
ICD-10 code description
Dislocation and sprain of joints and ligaments of knee
Primary outcomes
1
Description
Pain
Timepoint
Before and after the intervention
Method of measurement
VAS score
2
Description
Measuring the quality of life
Timepoint
Before and after the intervention
Method of measurement
ACL QOL questionnaire
3
Description
Walking speed
Timepoint
Before and after the intervention
Method of measurement
10-meter walking test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: quadriceps neuromuscular electrical stimulation with biphasic symmetric pulse waveform (300 μs phase deviation and 30 Hz frequency and maximum intensity of 100 mA on the vastus medialis muscle) for 10 sessions (number = 30) along with Infrared and Ultrasound to Duration of 10 minutes and exercises of the abductor, extensor muscles (3 sets and 20 repetitions), thigh, and Hamstring Curls exercise (3 sets and 30 repetitions).
Category
Rehabilitation
2
Description
Control group: Infrared and Ultrasound for 10 minutes and exercises of abductor, extensor muscles (3 sets and 20 repetitions), thigh, and Hamstring Curls exercise (3 sets and 30 repetitions) (number = 30).
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Baqiyatallah Hospital
Full name of responsible person
Arman Mahmodi
Street address
Vanak sq
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8126 7457
Email
msaberi@bmsu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Gholamhosein Alishiri
Street address
Vanak sq
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 8126 7457
Email
msaberi@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bagheiat-allah 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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Arman Mahmodi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Vanak sq
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 81261
Fax
Email
stu.armnmhmd@bmsu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Arman Mahmodi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Vanak sq
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 81261
Fax
Email
stu.armnmhmd@bmsu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Arman Mahmodi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Vanak sq
City
Tehran
Province
Tehran
Postal code
1435916471
Phone
+98 21 81261
Fax
Email
stu.armnmhmd@bmsu.ac.ir
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