Evaluation of the effect of continues and intermittent physical therapy on amount of pain and function in subjects with moderate knee osteoarthritis (pilot randomized clinical trial)
Determination of the effect of continuous and intermittent physiotherapy on the pain and function of patients with knee osteoarthritis.
Design
A pilot randomized clinical trial community based،double-blind(participant and outcome assessor.
Settings and conduct
Alzahra Medical Center.Participant and examiner are blind in this.
Participants/Inclusion and exclusion criteria
inclusion criteria:
Patients with moderate knee osteoarthritis who are above 40
Exclusion criteria:
Other problems associated with knee pain and function.
Intervention groups
The intervention includes 10 physiotherapy sessions. All patients (both groups) in physiotherapy sessions will receive the usual physical modalities equally. The difference between two groups is in the treatments sessions interval. one group receives physiotherapy treatment During 10 sessions everyday and one group receives physiotherapy treatment During10 sessions, three sessions a week (every other day).
Main outcome variables
Pain; function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171017036837N1
Registration date:2018-09-18, 1397/06/27
Registration timing:registered_while_recruiting
Last update:2018-09-18, 1397/06/27
Update count:0
Registration date
2018-09-18, 1397/06/27
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5041
Email address
mirbod@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-22, 1397/05/31
Expected recruitment end date
2019-03-20, 1397/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of continues and intermittent physical therapy on amount of pain and function in subjects with moderate knee osteoarthritis (pilot randomized clinical trial)
Public title
The effect of continues and every another day physical therapy on pain and function in subjects with knee osteoarthritis.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with primary knee osteoarthritis
Having criteria of knee osteoarthritis according to American college of rheumatology
Patients with grade 2 or 3 Kellgren-lawrence scale of moderate knee osteoarthritis
Age more than 40 years
Not being in the acute phase of the disease
Able to write and read
Men and women with moderate knee osteoarthritis
Body mass index less than 35
Exclusion criteria:
Systemic rheumatoid arthritis
Secondary knee osteoarthritis
Active knee synovitis
Severe knee trauma
Surgery intervention on knee during 1 year ago
Intra-articular injection of corticosteroids or hyaluronic acid for at least the last 6 months
Performing a physiotherapy treatment in the last 3 months
Taking of Non steroidal anti-inflammatory drug from a week before entering the study
Musculoskeletal disorders in lower extrimities
Disorders in lumbopelvic and hip region
Bilateral involvement of knees which one of them is grade 4 Kellgren-lawrence scale
Age
From 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Tools used in randomization (throwing coin)
Blinding (investigator's opinion)
Double blinded
Blinding description
Treatments are done by the researcher and evaluations are done by another assessor. The assessor doesn't know about patients grouping.The patients don't know about their group and other groups. since the treatment component was exactly the same in both groups except the frequency of sessions. the participants knew that they will receive standard physical therapy to determine its effect in Iranian subjects. Both groups truly receive standard intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences.
Street address
Secretariat of the Ethics Committee, Room 209, Second Floor, Building No. 4, Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
81745-164
Approval date
2017-09-11, 1396/06/20
Ethics committee reference number
IR.MUI.RESEARCH.REC.1396.3.436
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M17.9
ICD-10 code description
Osteoarthritis of knee, unspecified
Primary outcomes
1
Description
Pain
Timepoint
One day before the intervention and at the tenth session after the end of the treatment plan
Method of measurement
Visual Analogue Scale
2
Description
Function
Timepoint
One day before the intervention and at the tenth session after the end of the treatment plan
Method of measurement
Get up and go test
3
Description
Pain
Timepoint
One day before the intervention and at the tenth session after the end of the treatment plan
Method of measurement
Knee injury and osteoarthritis outcome score
4
Description
Pain
Timepoint
One day before the intervention and at the tenth session after the end of the treatment plan
Method of measurement
Intermittent and constant osteoarthritis pain
5
Description
Function
Timepoint
One day before the intervention and at the tenth session after the end of the treatment plan
Method of measurement
Six minute walk test
6
Description
Function
Timepoint
One day before the intervention and at the tenth session after the end of the treatment plan
Method of measurement
Knee injury and osteoarthritis outcome score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 3 times a week, for 10 sessions every another day will be done. Conventional physiotherapy treatment includes these: 1. Transcutaneous electrical nerve stimulation(TENS): 10HZ, 250 microsecond, 20 minutes, four electrodes medial and lateral to the superior and inferior poles of the patella 2. Hot moist pack for 20 minute 3. Ultrasound: 1 MHz, 2 Watt, 5 minutes, continuous(1-2 minute per 10 cm2) with circular motion covering medial, lateral and anterior aspects of the target knee joint. 4. Quadriceps setting 5. VMO setting
Category
Rehabilitation
2
Description
Control group: 6 times a week, for 10 sessions every day will be done. Conventional physiotherapy treatment includes these: 1. Transcutaneous electrical nerve stimulation(TENS): 10HZ, 250 microsecond, 20 minutes, four electrodes medial and lateral to the superior and inferior poles of the patella 2. Hot moist pack for 20 minute 3. Ultrasound: 1 MHz, 2 Watt, 5 minutes, continuous(1-2 minute per 10 cm2) with circular motion covering medial, lateral and anterior aspects of the target knee joint. 4. Quadriceps setting 5. VMO setting
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Medical Center
Full name of responsible person
Sayed Mohsen Mirbod
Street address
Sofeh boulevard
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3624 5004
Email
mirbod@rehab.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellery of Research and Technology
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Vice Chancellory Of Research and Technology،Isfahan University of Medical Sciences، Hezar Jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5012
Email
mirbod@rehab.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellery of Research and Technology
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
Esfahan University of Medical Sciences
Full name of responsible person
Sayed Mohsen Mirbod
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Anatomy
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 3089
Email
mirbod@rehab.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sayed Mohsen Mirbod
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Anatomy
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 3089
Email
mirbod@rehab.mui.ac.i
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Sayed Mohsen Mirbod
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Anatomy
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3669 3089
Email
mirbod@rehab.mui.ac.i
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