Protocol summary

Summary
1) Objectives: The purpose of this study is the comparison of effectiveness of neuromuscular electrical stimulation and proprioceptive neuromuscular facilitation on EMG and balance of knee osteoarthritis patients. 2) Design: In this study patients will be evaluated through main outcomes and then randomly assigned into 4 treatment groups. Patients will be treated for 4 weeks 3 session each week and will have reassessment after treatments and 1 month follow up. 3) Setting and conduct: Variables are balance, muscle electrical activity, pain and function which will be measured respectively by Biodex balance, EMG, VAS and WOMAC questioner. The instruments that will be used in this study is electro stimulator 620P, teraband for PNF pattern performance and ice pack in the ice therapy group. 4) Participants including major eligibility criteria: Those patients suffering from knee arthritis aged between 35-54 years old that will be referred from a specialist, achieving WOMAC score at least 25 and VAS score at least 4 will be included. 5) Intervention: Patients will be randomly allocated to 4 groups: 1) Routine physical therapy with NMES and PNF on quadriceps and hamstring muscles 2) Routine physical therapy with PNF on hamstring and quadriceps 3) Routine physical therapy with icing for hamstring and PNF for quadriceps 4) Routine physical therapy with routine exercise 6) Main variables: Pain, function, balance and electromyography (EMG)

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017011226443N3
Registration date: 2017-05-01, 1396/02/11
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-05-01, 1396/02/11
Registrant information
Name
Ahmad Reza Asgari Ashtiani
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5438
Email address
drasgari@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Zahedan University of Medical Sciences
Expected recruitment start date
2017-02-19, 1395/12/01
Expected recruitment end date
2017-07-21, 1396/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effectiveness of neuromuscular electrical stimulation and proprioception neuromuscular facilitation on EMG and balance in knee osteoarthritis
Public title
Comparison of effectiveness of neuromuscular electrical stimulation and proprioception neuromuscular facilitation on EMG and balance in knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Main inclusion ctiteria: Confirmation of knee osteoarthritis diagnosis by an specialist; WOMAC score 25 at least; VAS 4 at least; age between 35 it 54 Main exclusion criteria: History of knee fracture, tendon, meniscus and ligament tearing; rheumatoid arthritis; hip or ankle musculoskeletal disorders; central or peripheral neuropathy; history of physical therapy in last month; corticosteroid injection in last month; unconscious patients; neoplasy disorders, deep vain thrombosis, neurological dysfunction; sever obesity; pace maker
Age
From 35 years old to 54 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Zahedan University of Medical Sciences
Street address
Deputy of Research, Zahedan University of Medical Sciences, Jannat Blvd., Dr. Hesabi Sq.
City
Zahedan
Postal code
Approval date
2016-12-18, 1395/09/28
Ethics committee reference number
IR.ZAUMS.REC.1395.234

Health conditions studied

1

Description of health condition studied
knee osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Other primary gonarthrosis

Primary outcomes

1

Description
electeromyographic activity
Timepoint
before and after intervention and 1 month later
Method of measurement
EMG

Secondary outcomes

1

Description
pain
Timepoint
before and after intervention and 1 month later
Method of measurement
VAS

2

Description
balance
Timepoint
before and after intervention and 1 month later
Method of measurement
biodex balance system

3

Description
function
Timepoint
before and after intervention and 1 month later
Method of measurement
WOMAC questionnaire

Intervention groups

1

Description
Second interventional group: Routine physical therapy treatment with quadriceps and hamstring strengthening by PNF pattern
Category
Rehabilitation

2

Description
First interventional group: Routine physical therapy treatment with quadriceps strengthening by PNF pattern and hamstring inhibition by ice
Category
Rehabilitation

3

Description
Third interventional group: Routine physical therapy with quadriceps and hamstring strengthening by PNF pattern and NMES
Category
Rehabilitation

4

Description
Control group: Routine physical therapy
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Razmjou Moghadam clinic
Full name of responsible person
Bahareh Khodadadi
Street address
Kafami street. Razmjou Moghadam laboratory. Zahedan
City
Zahedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, Zahedan University of Medical Sciences
Full name of responsible person
Dr. Mohsen Taheri
Street address
Jannat Blvd., Dr. Hesabi Sq, Zahedan University of Medical Sciences, Deputy of Research
City
Zahedan
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, Zahedan 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
Zahedan University of Medical Science
Full name of responsible person
Bahareh Khodadadi Bohlouli
Position
master student
Other areas of specialty/work
Street address
Dr.Hesabi square, Zahedan University of Medical Science,School of Rehabilitation Sciences, Department of Physiotherapy
City
Zahedan
Postal code
Phone
+98 54 3329 5836
Fax
Email
bahereh_khodadadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Reza Asgari Ashtiyani
Position
Ph.D in Physiotherapy
Other areas of specialty/work
Street address
Dr.Hesabi square, Zahedan University of Medical Science,School of Rehabilitation Sciences,Department of Physiotherapy
City
Zahedan
Postal code
Phone
+98 54 3329 5836
Fax
Email
ahmadaskary@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr. Ahmad Reza Asgari Ashtiyani
Position
Ph.D in Physiotherapy
Other areas of specialty/work
Street address
Dr.Hesabi square, Zahedan University of Medical Science,School of Rehabilitation Sciences, Department of Physiotherapy
City
Zahedan
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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