Comparative study of the efficacy of three protocols of Neuromuscular Electrical Stimulation (NMES), exercise therapy and NMES combined with exercise therapy on pain, quadriceps muscle thickness, and physical function of patients with knee osteoarthritis: A controlled randomized trial with a three-month follow-up
Determine the effectiveness of three protocols of neuromuscular electrical stimulation, exercise therapy and neuromuscular electrical stimulation and combined exercise therapy on pain, quadriceps muscle atrophy, vastus medialis muscle thickness, and physical function in patients with primary knee osteoarthritis
Design
In this study, three groups will be treated in parallel. First, the checklist of the research is completed. Then, other clinical, functional and sonographic evaluations will be performed.
Settings and conduct
This study will be performed on patients with knee osteoarthritis at Rasool Akram Hospital Sports Medicine Clinic.
In this study, the assessor and statistician analyzer are going to be blinded to the study groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Primary osteoarthritis (OA); OA of the knee joint;ّ Female gender; Age between 50-75 years; BMI equal to or less than 30.
Non-inclusion criteria: History of the neuromuscular disease; Bone implants; Participating in exercise therapy and physical therapy programs in the recent three months; history of knee intra-articular injection during last 6 months.
Intervention groups
Intervention group 1: Interferential Therapy for 12 sessions to strengthen their quadriceps muscle.
Intervention group 2: In addition to NMES will also receive the therapeutic exercises program.
Control group: Exercise therapy or control group (CL)- An exercise protocol for the OA patients consisted of five exercises.
Main outcome variables
Pain; Active knee flexion range of motion; The circumference of the thigh; The thickness of the Vastus Medialis muscle; Physical Function.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101228005486N7
Registration date:2020-02-06, 1398/11/17
Registration timing:prospective
Last update:2020-02-06, 1398/11/17
Update count:0
Registration date
2020-02-06, 1398/11/17
Registrant information
Name
Azar Moezy
Name of organization / entity
Iran university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6435 2446
Email address
moeziazr@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the efficacy of three protocols of Neuromuscular Electrical Stimulation (NMES), exercise therapy and NMES combined with exercise therapy on pain, quadriceps muscle thickness, and physical function of patients with knee osteoarthritis: A controlled randomized trial with a three-month follow-up
Public title
Exercise therapy and NMES in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Primary OA of the knee joint grade 2, 3 according Kellgren and Lawrence scale
Female gender
Age between 50-75 years old
Knee pain for at least six months and with intensity 3 on the VAS scale in activities such as getting up and downstairs, sitting and squat
No history of knee intra-articular injection in the past six months
Referral from a specialist
No history of acute traumatic injuries approved by the referral physician
No history of previous surgery or injury in the knee joints and lower extremities
BMI equal or less than 30
Patient's consent to participate in the research
Normal mental state
Exclusion criteria:
History of neuromuscular disease
Bone implants
History of new fractures in lower limbs
Participating in exercise therapy and physical therapy programs in the recent three months
History of chronic disease and generally any disease or conditions that known to affect the investigation
Malignant tumors
Age
From 50 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will randomly be assigned to three treatment groups employing a block randomization method with blocks of size three, produced by PASS software.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the assessor is going to be blinded to the study groups. The outcomes will be evaluated pre and post-intervention by a sports medicine assistant who will be blind about the presence of patients within the groups.
Furthermore, the sonography of thigh muscles is done by a sports medicine specialist who won't be aware of the patient groups.
Similarly, the data obtained from the study are going to be analyzed by a statistician who isn't aware of the patient groups.
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, next to Milad Tower, Hemat highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2019-11-17, 1398/08/26
Ethics committee reference number
IR.IUMS.FMD.REC.1398.351
Health conditions studied
1
Description of health condition studied
Primary knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain
Timepoint
Pre-intervention and Post-intervention
Method of measurement
VAS pain scale
2
Description
Active knee range of flexion
Timepoint
Pre-intervention and Post-intervention
Method of measurement
Goniometery
3
Description
The circumference of the thigh
Timepoint
Pre-intervention and Post-intervention
Method of measurement
With centimeter tape
4
Description
Muscle strength of knee extensors
Timepoint
Pre-intervention and Post-intervention
Method of measurement
Manual Muscle Testing
5
Description
Thickness of Vastus Medialis muscle
Timepoint
Pre-intervention and Post-intervention
Method of measurement
Sonography
Secondary outcomes
1
Description
Functional Activity
Timepoint
Pre -intervention and Post -intervention
Method of measurement
Timed Up & Go Test and Six-Minute Walk Test
Intervention groups
1
Description
First intervention group: The Patients in Neuromuscular Electrical Stimulation (NMES) will be treated with Interferential Therapy for 12 sessions (three sessions per week) to strengthen their quadriceps muscle. In this study, Pre-Modulated IF two-pole currents will be used by BTL-4825 S Topline combined electrotherapy system .
Category
Rehabilitation
2
Description
Second intervention group: The Patients in this group in addition to Neuromuscular Electrical Stimulation (NMES) similar to the first intervention group will also receive the therapeutic exercises program of the control group .
Category
Rehabilitation
3
Description
Control group: Exercise protocol for the patients in the control group consisted of five exercises:1.Static contraction of the quadriceps femoris in a supine position - The patient is asked to lie in the supine position and statically contract the thigh muscles. It will be done for each leg in three sets of 10 repetitions and the duration of static contraction is 10 seconds. 2. Straight legs raising (SLR) in a supine position - The patient is asked to lie in the supine position with one knee in flexed position and raise the other leg straightly. It will be done for each leg in three sets of 10 repetitions and keeping SLR with a ten- second hold. 3.Terminal knee extension n a supine position - The patient is asked to lie in the supine position with one pillow under one of the knees; then the patient should try to extend the flexed knee at the terminal range. In the first two weeks, it will be done in three sets of 10 repetitions with a ten- second hold. 4.Static contraction of hip adductors- The patient is asked to lie in the supine position with the knee flexed and one pillow between the thighs. The patient is asked to press the thighs into the pillow.The exercise will be done in three sets of 10 repetitions for the legs in the first two weeks with a 10-second hold. 5.Wall-sit-The patient is asked to lean against the wall and spread his legs as wide as his shoulders. Then bend your knees slowly to 90 degrees flexion and hold this position for 10 seconds. This exercise will be done in three sets of 10.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Rasool Akram Hospital
Full name of responsible person
Dr Soheila Masoudi
Street address
Sports Medicine Department, Hazrat Rasool Akram Hospital, Niayesh street, Shahrara, Sattarkhan street
City
Tehran
Province
Tehran
Postal code
14455613131
Phone
+98 21 6435 2446
Fax
+98 21 6651 7309
Email
saba.17302@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Azar Moezy
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2446
Fax
+98 21 6650 9108
Email
moezy.a@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr Soheila Masoudi
Position
Sports Medicine Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Hazrat Rasool Akram Hospital, Niayesh street, Sattarkhan street
City
Tehran
Province
Tehran
Postal code
14455613131
Phone
+98 21 6435 2446
Fax
+98 21 6651 7309
Email
saba.17302@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Azar Moezy
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Physical Therapy
Street address
Sports Medicine Department, Hazrat Rasool Akram Hospital, Niayesh street, Sattarkhan street
City
Tehran
Province
Tehran
Postal code
14455613131
Phone
+98 21 6435 2446
Fax
+98 21 6651 7309
Email
moezy.a@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Azar Moezy
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Sports Medicine Department, Hazrat Rasool Akram Hospital, Niayesh street, Sattarkhan street
City
Tehran
Province
Tehran
Postal code
14455613131
Phone
+98 21 6435 2446
Fax
+98 21 6651 7309
Email
moezy.a@iums.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
Due to ethical standards, The participants have been promised that the information of this research will remain confidential in their written consent form.
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
A portion of the data, such as data on the main outcome or like that can be shared.
When the data will become available and for how long
One year after the publication of articles related to the research project
To whom data/document is available
The researchers and specialists working in universities and health centers
Under which criteria data/document could be used
Analysis on the delivered data after obtaining permission from the researchers
From where data/document is obtainable
Dr Azar Moezy -Sports Medicine Department, Hazrat Rasool Akram Hospital, Niayesh St, Sattarkhan Ave, Zip code:14455613131,Tehran.
What processes are involved for a request to access data/document
The applicant of the data file should send a request to the researcher via an email and the researcher will inform the applicant after negotiating with other research colleagues, and this process will take a maximum of one month.