effect of Augmented High Intensity Laser Therapy (HILT) to Electrical Stimulation (NMES) and Exercise Therapy on Muscle Strength, Pain and Function in Patients with Knee Osteoarthritis Grade II and III: a randomized controlled trial
Investigation the effects of augmented high intensity LASER therapy with electrical stimulation and exercise therapy on muscle strength and pain and function in patients with knee osteoarthritis grade II and III : A Randomized Clinical Trial
Design
Clinical trial with control group, Two arm parallel group,double blind with blinded outcome evaluator and participants, simple randomaised
Settings and conduct
Participants after having inclusion criteria for entry to test randomly simple in two groups
control group: Placebo high intensity LASER with neuromuscular electrical stimulation and exercise therapy
Treatment group: High intensity LASER with neuromuscular electrical stimulation and exercise therapy
Ten treatment sessions were done for participants. Assessment of participants done before and after treatment, session10, A month and a half after treatmen. Assessment of pain performed with visual analog scale, strength of quadriceps muscle with manual dynamometer and function with Western Ontario and McMaster Universities Arthritis Index.This is a double-blind study with blinded outcome evaluator and participants.All stages of study were conducted at Ahwaz Jundishapour University of Medical Sciences.
Participants/Inclusion and exclusion criteria
inclusion criteria: Radiographic evidence of knee and knee osteoarthritis,
Knee pain for at least three months, physiotherapy and injection within the last six months. no pacemaker, cardiovascular disease, knee arthroplasty, tumor and deep vein thrombosis.
Exclusion criteria:
No willing the samples to continue the treatment process
Intervention groups
control group: Placebo high intensity LASER with neuromuscular electrical stimulation and exercise therapy
Treatment group: High intensity LASER with neuromuscular electrical stimulation and exercise therapy
Main outcome variables
Pain
Strength of Quadriceps muscle
function
General information
Reason for update
Acronym
ندارد
IRCT registration information
IRCT registration number:IRCT20181024041442N1
Registration date:2019-02-10, 1397/11/21
Registration timing:retrospective
Last update:2019-02-10, 1397/11/21
Update count:0
Registration date
2019-02-10, 1397/11/21
Registrant information
Name
Shahin Goharpay
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3101
Email address
goharpay-sh@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
effect of Augmented High Intensity Laser Therapy (HILT) to Electrical Stimulation (NMES) and Exercise Therapy on Muscle Strength, Pain and Function in Patients with Knee Osteoarthritis Grade II and III: a randomized controlled trial
Public title
effect of high intensity laser therapy on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Radiographic evidence of knee osteoarthritis grade II and III according to the Kellgren-Lawrence classification and based on American College of Rheumatology (ACR) criteria
knee pain for at least 3 months.
without application of injection or physiotherapy during the last six months
Exclusion criteria:
Not willing the samples to continue the treatment process
Age
From 50 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomized
Individual
Use the random numbers table
People first enter each number next members were selected with 5 spacing
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants did not know the presence of the control group. Also, they did not know what treatment group they were supposed to be.
Assessing the outcome without knowing the types of groups and
types of treatments evaluated the participants before and after treatment.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Depatment of Physical Therapy, School of Rehabilitation Sciences, Ahwaz Jundishapur University of Medical Sciences, Ahwaz, Iran
City
Ahwaz
Province
Khouzestan
Postal code
61357-33133'
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.AJUMS.REC.1397.267
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis Grade II and III
ICD-10 code
M15.9
ICD-10 code description
Generalized Osteoarthritis NOS
Primary outcomes
1
Description
pain
Timepoint
before treatment, session10, A month and a half after treatment
Method of measurement
The visual Analog scale of pain. score is from 0 to 100 mm. 100 max pain and 0 painless state.
2
Description
strength of quadriceps
Timepoint
before treatment, session10, A month and a half after treatment
Method of measurement
manual dynamometer
Secondary outcomes
1
Description
function
Timepoint
before treatment, session10, A month and a half after treatment
Method of measurement
Western Ontario and McMaster Universities Arthritis Index
Intervention groups
1
Description
Intervention group includes high intensity laser with neromuscular electrical simulator and exercise therapy
Category
Treatment - Devices
2
Description
Control group includes neromuscular electrical simulator and exercise therapy
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvar Jondishapour University of Medical Sciences
Full name of responsible person
Dr. Shahin Goharpey
Street address
Golestan Blvd
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3374 3505
Email
shgoharpey@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Badvi
Street address
Golestan Blvd
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3374 3505
Email
Shgoharpey@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Shahin Goharpey
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Golestan Blvd
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3374 3505
Email
shgoharpey@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Shahin Goharpey
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Golestan Blvd
City
Ahwaz
Province
Khouzestan
Postal code
15794-61357
Phone
+98 61 3374 3505
Email
shgoharpey@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shahin Goharpay
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Department of Physical Therapy, School of Rehabilitation Sciences, Ahvaz Jundishpur University of Medical Sciences, Ahvaz, Iran
City
Ahwaz
Province
Khouzestan
Postal code
61357-33133
Phone
+98 61 3374 3101
Fax
Email
goharpay-sh@ajums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available