Protocol summary

Study aim
the investigation of the treatment effect based on movement system impairment classification theory in people with knee pain
Design
a randomized controlled trial with equivalent intervention and control groups, single blinded on 60 patients, consecutive simple individual randomization (in order of referral)
Settings and conduct
place: Shahid Beheshti physiotherapy clinic. After examination and diagnosis of movement impairment, the expert colleague classify them into intervention and control groups randomly. During 10 sessions in 6 weeks, researcher accomplishes the predetermined physiotherapy treatments for each group. data collection, outcome measure assessment , data analysis is done by the colleague,using questionnaires for investigating function and disability, visual analogue scale and video camera to recording knee projection angle
Participants/Inclusion and exclusion criteria
inclusion criteria: patients with knee rotational syndrome or patellar lateral glide syndrome. Pain at least 3 on the visual analog scale. knee Pain during running or jumping. exclusion criteria: pregnancy
Intervention groups
intervention1:patients with knee rotation syndrome with valgus control 1: patients with knee rotation syndrome with valgus intervention 2:patients with knee rotation syndrome with varus control 2: patients with knee rotational syndrome with varus intervention 3:patients with patellar lateral glide syndrome control 3: patients with patellar lateral glide syndrome similar treatments for control groups:10 sessions in 6 weeks: , electrotherapy,Ultrasound, exercices. intervention groups : the above treatment plus education and modification of functional activities, improve performance of hip lateral rotators and abductors and extensibility of iliotibial band
Main outcome variables
pain intensity, disability Level, Function level, Knee frontal plane projection angle.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190222042801N1
Registration date: 2020-12-17, 1399/09/27
Registration timing: retrospective

Last update: 2020-12-17, 1399/09/27
Update count: 0
Registration date
2020-12-17, 1399/09/27
Registrant information
Name
Parisa Zamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2277 1801
Email address
drarmani.20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
2019-08-22, 1398/05/31
Actual recruitment end date
2019-08-22, 1398/05/31
Trial completion date
2019-08-22, 1398/05/31
Scientific title
the effect of treatment based on movement system impairment classification theory in people with knee pain (a randomized control trial)
Public title
the effect of physiotherapy on knee pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
patients with knee rotation syndrome or pateller lateral glide syndrome knee pain during running or jumping knee pain at least 3 on visual analog scale
Exclusion criteria:
Pregnancy
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
the sampling method in the present study is consecutive. It means that the expert colleague gets present at the patients' referral site (Shahid Beheshti rehabilitation clinic) from the beginning of the study, and patients who are eligible to participate in the study are identified and then, invited to participate in the study. Therefore, randomization is occurred consecutively. It should be noted that only one rehabilitation center is sampled in this study. In this study, simple randomization method is used and randomization unit is individual. In this way,the eligible participant with diagnosis of having one of the three identified movement impairment syndrome is classified to a primary group with the other ones with the same impairment first. then in each group with the same movement impairment people are numbered by order of their referral. individuals who the odd number assigned to them are included in intervention group and participants with the even numbers are included in control groups.for example, if the primary diagnosis is rotational syndrome with varus,number one is assigned to the first participant with this movement impairment and number two assigned to the second one with the same diagnosis. so the first odd number is included in intervention group for rotational syndrome with varus and the second person with this syndrome with even number two is included to control group of the same subcategory and the way is continued until the assigned number of each group are entered in to the study for this diagnosis group. randomization for other subcategories are done the same way based on their primary diagnosis and by order of their referral.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study، the expert experienced colleague who has passed more than 100 hours instructions in clinical diagnosis of movement system impairment is responsible to do: 1-Systematic examinations and diagnosis the movement system impairments of the clients 2- Randomization of participants into intervention or control groups. All of these procedures are done based on the study inclusion criterion and clinical recognition conceptions of the movement system impairment theory, furthermore; the researcher is blind to them. But all treatment sessions are done completely by the researcher. All intervention groups are treated specifically based on the movement system impairment classification theory for knee pain and all control groups treatments are based on routine treatment protocols for knee pain suggested by physiotherapy reference texts. Data collection in predetermined times is done by another co worker who is blind same as the researcher. Outcome measure assessment and data analysis are done by statistics consultant of the project but the researcher is also blind to all of these.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
Jondishapour University of Medical Sciences., Golestan St., Golestan Hwy
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2019-01-15, 1397/10/25
Ethics committee reference number
IR.AJUMS.REC.1397.744

Health conditions studied

1

Description of health condition studied
knee pain
ICD-10 code
M25.56
ICD-10 code description
knee Pain

Primary outcomes

1

Description
pain intensity
Timepoint
Before treatment beginning, at the end of the third week in the middle of treatment period, at the end of the sixth week after treatment finishing and at the twelfth week the end of follow up period.
Method of measurement
with visual analog scale

2

Description
disability level
Timepoint
Before treatment beginning, at the end of the third week in the middle of treatment period, at the end of the sixth week after treatment finishing and at the twelfth week the end of follow up period.
Method of measurement
with knee injury and osteoarthritis outcome score questionnaire

3

Description
function level
Timepoint
Before treatment beginning, at the end of the third week in the middle of treatment period, at the end of the sixth week after treatment finishing and at the twelfth week, the end of follow up period.
Method of measurement
with lower extremity functional scale questionnaire

4

Description
knee joint frontal plane projection angle
Timepoint
Before treatment beginning, at the end of the sixth week after treatment finishing and the end of the twelfth week, after follow up period.
Method of measurement
with video camera and Kinovea software

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Patients with knee rotation syndrome with valgus who are given specific treatment based on movement system impairment classification theory within 10 sessions in 6 weeks. Each session takes one hour and a half including specific treatments plus routine ones. Specific treatments including: 1- Improve muscle performance of hip lateral rotators and abductors 2- Improve extensibility of iliotibial ( I.T.B) band 3- Posterior x taping of knee 4- Education and modification of functional activities that contribute to impaired motion of knee 5- address pronation foot; Routine physiotherapy treatments including: 1- Hot pack 2- Electrical stimulation ( inferential current around knee and functional electrical stimulation on knee muscles) 3- Ultrasound wave with 3 MHz frequency with continuous mode on lateral and posterior aspect of knee In the earlier four weeks, every week we should accomplish two treatment sessions and during two weeks after, each week one treatment session is done .
Category
Rehabilitation

2

Description
Intervention group 2: Patients with knee rotation syndrome with varus who are given specific treatment based on movement system impairment classification theory within 10 sessions in 6 weeks. Each session takes one hour and a half including specific treatments plus routine ones. Specific treatments including: 1- Improve muscle performance of hip lateral rotators and abductor 2- Improve extensibility of iliotibial ( I.T.B) band 3- Posterior x taping of knee 4- Education and modification of functional activities that contribute to impaired motion of knee 5- Improve shock absorb- heel to toe pattern; Routine physiotherapy treatments including: 1- Hot pack 2- Electrical stimulation ( inferential current around knee and functional electrical stimulation on knee muscles) 3- Ultrasound wave with 3 MHz frequency with continuous mode on lateral and posterior aspect of knee In the earlier four weeks, every week we should accomplish two treatment sessions and during two weeks after, each week one treatment session is done .
Category
Rehabilitation

3

Description
Intervention group 3: patients with patellar lateral glide syndrome who are given specific treatment based on movement system impairment classification theory within 10 sessions in 6 weeks. Each session takes one hour and a half including specific treatments plus routine ones. Specific treatments including: 1-Limit prolonged knee flexion 2-Improve muscle performance of quadriceps 3- Improve extensibility of iliotibial band 4- Mobilization- patellar medial glide 5- Medial taping of patella; Routine physiotherapy treatments including: 1- Hot pack 2- Electrical stimulation ( inferential current around knee and functional electrical stimulation on knee muscles) 3- Ultrasound wave with 3 MHz frequency with continuous mode on lateral and posterior aspect of knee In the earlier four weeks, every week we should accomplish two treatment sessions and during two weeks after, each week one treatment session is done .
Category
Rehabilitation

4

Description
Control group 1: patients with knee rotation syndrome with valgus who are given the same routine physiotherapy treatment regardless of their movement impairment. Each session takes one hour and a half including: 1-Hot pack 2-Electrical stimulation ( inferential current around knee and functional electrical stimulation on knee muscles) 3- Ultrasound wave with 3 MHz frequency with continuous mode on lateral and posterior aspect of knee 4- Quadriceps strengthening exercise and stretching posterior muscles of the knee In the earlier four weeks, every week we should accomplish two treatment sessions and during two weeks after, each week one treatment session is done .
Category
Rehabilitation

5

Description
Control group 2: patients with knee rotation syndrome with varus who are given the same routine physiotherapy treatment regardless of their movement impairment. Each session takes one hour and a half including: 1-Hot pack 2-Electrical stimulation ( inferential current around knee and functional electrical stimulation on knee muscles) 3- Ultrasound wave with 3 MHz frequency with continuous mode on lateral and posterior aspect of knee 4- Quadriceps strengthening exercise and stretching posterior muscles of the knee In the earlier four weeks, every week we should accomplish two treatment sessions and during two weeks after, each week one treatment session is done .
Category
Rehabilitation

6

Description
Control group 3: patients with patellar lateral glide syndrome who who are given the same routine physiotherapy treatment regardless of their movement impairment. Each session takes one hour and a half including: 1-Hot pack 2-Electrical stimulation ( inferential current around knee and functional electrical stimulation on knee muscles) 3- Ultrasound wave with 3 MHz frequency with continuous mode on lateral and posterior aspect of knee 4- Quadriceps strengthening exercise and stretching posterior muscles of the knee In the earlier four weeks, every week we should accomplish two treatment sessions and during two weeks after, each week one treatment session is done .
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physiotherapy clinic of Rehabilitation Faculty , Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Mohammad Jafar Shaterzadeh Yazdi
Street address
Shahid Beheshti Physiotherapy Clinic., Physiotherapy group., Rehabilitation Faculty., Shahid Beheshti University of Medical Science., Damavand street ( in front of Buali Hospital)
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 7756 1721
Fax
+98 21 7759 1807
Email
Shaterzadeh.pt@gmail.com
Web page address
http://rehab.sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ahmadimoghadam
Street address
research and technology department., university department., Jondishapour University of Medical Science., Golestan St., Golestan Hwy
City
Ahwaz
Province
Khouzestan
Postal code
61357 -15794
Phone
+98 61 3373 8383
Email
ahmadi-m@ajums.ac.ir
Web page address
http://rehab.ajums.ac.ir
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. Mohammad Jafar Shaterzadeh
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy Group., Rehabilitation Faculty., Jondishapour University of Medical Science., Golestan street., Golestan Highway
City
Ahwaz
Province
Khouzestan
Postal code
33133 -61357
Phone
+98 33743103
Fax
+98 61 3374 3506
Email
Shaterzadeh.pt@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr Khosrow Khademi Kalantari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy Group., Rehabilitation Faculty., Shahid Beheshti Univercity of Medical Science., Damavand St ( in front of Buali Hospital)
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 23 87121
Email
Khosro_khademi@yahoo.co.uk

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Jafar Shaterzadeh Yazdi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Physiotherapy Group., Rehabilitation Faculty., Jondishapour University of Medical Science., Golestan St., Golestan Hwy
City
Ahwaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3374 3103
Email
Shaterzadeh.pt@gmail.com
Web page address
https://frehabilitation.ajums.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
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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