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Effect of exercise therapy with and without intra-articular hyaluronic acid injection on the COP sway and its location in the base of support and physical function in patients with knee osteoarthritis

Protocol summary

Study aim
: Effect of exercise therapy with and without intra-articular hyaluronic acid injection on the COP sway and its location in the base of support and physical function in patients with knee osteoarthritis.
Design
randomized clinical trial with control group and single blind. 24 volunteer knee OA with HA injection and 12 patients without injection enrolled in this study. The patients with HA injection randomly divided in two exercise+HA injection and HA injection( N=12 in each group). Block randomization (permuted blocks of 3) was done using closed sealed envelope.
Settings and conduct
The patients were divided into 3 groups: Group exercise+ HAinjection received combination of 15 sessions of conventional exercise with three HA injections (1 injection weekly for 3 weeks)، Group HA injection, received 3 intra-articular hyaluronic acid (1 injection weekly for 3 weeks) and control group performed the conventional exercise for 15 sessions. Outcomes measures were included some questionnaire (VAS,WOMAC, Lequesne, SF-36), COP sway in static balance,location of COP in the base of support,functional balance tests and lower limb muscle strength. All patients were evaluated before and 5 weeks after the beginning of the treatment.
Participants/Inclusion and exclusion criteria
: 36 volunteer patients with grade II or III of OA based on Kellgren-Lawrence (K/L) grading system ), 45- 70 years(, and 15 age-matched healthy subjects without osteoarthritis, via simple non-probability method participated in this study exclude criteria: osteoporosis, flat foot, lower limb surgery, knee meniscus and ligament tears, diabetes, hyper tension
Intervention groups
Group intervention 1, intra-articular hyaluronic acid and conventional exercise (n=12), Group intervention 2, intra-articular hyaluronic acid and control group(n=12)
Main outcome variables
pain, quality of life, functional balance, static balance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101017004952N10
Registration date: 2020-01-03, 1398/10/13
Registration timing: retrospective

Last update: 2020-01-03, 1398/10/13
Update count: 0
Registration date
2020-01-03, 1398/10/13
Registrant information
Name
Giti Torkaman
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4509
Email address
torkamg@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-11-20, 1395/08/30
Expected recruitment end date
2018-09-21, 1397/06/30
Actual recruitment start date
2017-01-19, 1395/10/30
Actual recruitment end date
2017-11-11, 1396/08/20
Trial completion date
2018-02-18, 1396/11/29
Scientific title
Effect of exercise therapy with and without intra-articular hyaluronic acid injection on the COP sway and its location in the base of support and physical function in patients with knee osteoarthritis
Public title
Effect of exercise therapy with and without intra-articular hyaluronic acid in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
grade II or III of OA based on Kellgren-Lawrence the ages of 45 and 70 year Primary symptomatic knee osteoarthritis for at least 6 between No other treatments for 6 months prior to the study Pain for at least 3 months Muscle strength at least 3 using dynamometer
Exclusion criteria:
osteoporosis Participating muscle strengthening plan at least for 3 months ago Meniscal lesions Lower limb surgery Hard flat foot Knee valgus>15 and knee varus> 10 Corticosteroid injection in 6 months ago Suffering any other arthritis Serious systemic or nervous disease Visual disturbance Vestibular, neurologic, neuromuscular & chronic orthopedic disease Joint injury Severe muscle weakness
Age
From 45 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 36
Actual sample size reached: 36
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization (permuted blocks of 6) was done using closed sealed envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
assessor was blinded about the kind of intervention
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical committee of Tarbiat modares university
Street address
Jalal Al Ahmad Street
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2016-03-02, 1394/12/12
Ethics committee reference number
IR.TMU.REC.1394.273

Health conditions studied

1

Description of health condition studied
Knee osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis

Primary outcomes

1

Description
balance,center of pressure sway
Timepoint
before and 5 weeks after the beginning of the treatment.
Method of measurement
Force plate

2

Description
CoP location in base of support
Timepoint
before and 5 weeks after the beginning of the treatment
Method of measurement
Force plate

Secondary outcomes

1

Description
Quality of life
Timepoint
before and 5 weeks after the beginning of the treatment.
Method of measurement
SF-36, WOMAC

2

Description
Functional activity
Timepoint
before and 5 weeks after the beginning of the treatment.
Method of measurement
6-min walk, timed up and go, star excursion, 8-walking test

Intervention groups

1

Description
Group intervention 1: Conventional exercise therapy and 3 intra-articular injection of Hyalgan in knee osteoarthritis patients (n=12)
Category
Rehabilitation

2

Description
Group intervention 2: three intra-articular injection of Hyalgan in knee osteoarthritis patients (n=12)
Category
Rehabilitation

3

Description
control group: Conventional exercise therapy in knee osteoarthritis patients (n=12)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Tarbiat Modares University
Full name of responsible person
Giti Torkaman
Street address
Jala AleAhmad Ave., Nasr
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4509
Email
torkamg@modares.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Yaghoub Fatholahi
Street address
Jalale Ale Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Fax
+98 21 8800 6544
Email
res@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares university
Full name of responsible person
Giti Torkaman
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Jalal Al Ahmad St
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4509
Email
torkamg@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Giti Torkaman
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Jalal Al Ahmad St
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4509
Email
torkamg@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat modares university
Full name of responsible person
Elham Rostami Mehr
Position
Graduated
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Jalal Al Ahmad St
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 0000
Email
r.elham1370@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data will be shared after confirmation of chief researcher
When the data will become available and for how long
6 months after publication
To whom data/document is available
All researchers
Under which criteria data/document could be used
For scientific purposes
From where data/document is obtainable
Dr Giti Torkaman
What processes are involved for a request to access data/document
Confirmation of chief researcher
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