The comparison of treatment using Movement System Impairment method with routine physical therapy in improving pain and function in patents with knee pain: A randomized clinical trial
The comparison of treatment using Movement System Impairment method with routine physical therapy in patents with knee pain
Design
A randomized clinical trial study, dabble-blind, parallel-group, 40 patients with knee pain randomized to one intervention group and one control group through web-based randomization
Settings and conduct
After evaluation by a physician, and inclusion-exclusion criteria, the researcher records the personal information of patients among with the signed consent form. Patients are gathered from clinics affiliated to Tehran University of Medical Sciences. After that, the pain records along with lower extremity functional questionnaire. Then, the alignments of thigh, shank and knee records in different positions of daily activities and the pain adds as well. Then, a syndrome is allocated to each patient based on the findings of researcher. Being categorized to a treatment group by randomization, then the patient receives the special treatments of each group. Exercises of Movement Impairment System group consists of specific exercises of each syndrome while routine physiotherapy group consists of stretching and strengthening exercises. Both groups are evaluated again after 6 weeks and the results are compared by statistical tests.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 18-65, Knee pain at least 2 months before enrollment, Pain scale of 30-70 based on a Numeral Rating Scale. Exclusion Criteria: The confirmation of the need for surgery. Systematic, Metabolic, or Neurologic disease (such as radiculopathy) Pregnancy. The need for analgesic or anti-inflammatory drugs during the treatment period
Intervention groups
Treatment with Movement System Impairment method
Treatment with routine physiotherapy method
Main outcome variables
Pain, Function, Knee Alignment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180627040251N5
Registration date:2023-03-30, 1402/01/10
Registration timing:registered_while_recruiting
Last update:2023-03-30, 1402/01/10
Update count:0
Registration date
2023-03-30, 1402/01/10
Registrant information
Name
Hassan Sadeghi
Name of organization / entity
Kharazmi University
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8001
Email address
hassan.sadeghi81@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-28, 1402/01/08
Expected recruitment end date
2023-04-28, 1402/02/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of treatment using Movement System Impairment method with routine physical therapy in improving pain and function in patents with knee pain: A randomized clinical trial
Public title
Comparison between MSI and routine physiotherapy treatments in knee pain patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Knee pain at least 2 months before examination
Pain between 30-70 based on "Numeral Rating Scale"
Exclusion criteria:
The confirmation of the need for surgery
Systematic, Metabolic or Neurologic disease (such as radiculopathy)
Pregnancy
The need for analgesic or anti-inflammatory drugs during the treatment period
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomized into intervention and one control group using an online randomization system (randomizer.org). A member of the research team who is not involved in the selection of samples will determine the randomization sequence using a computer program. Participants will be notified of their group allocation with a sealed envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients are aware of the study, but they are not aware of each exercise in each method and only perform each given exercise. Then the patients are evaluated by an examiner while another person teaches the exercises to patients. At the end of study, the patients are again assessed by the same examiner while the examiner is not aware of patient's grouping. Furthermore, the statistician analyzes the data who is not aware of each treatment group's conditions.
1) Pain score based on Numeral Rating Scale of 0-100. 100 shows the worst pain and 0 is the least amount of pain.
Timepoint
At the start of the study (Before intervention) and 6 weeks after the start of the study (End of study)
Method of measurement
Pain is evaluated by marking on a line which is divided to 100 points.
Secondary outcomes
1
Description
knee alignment
Timepoint
At the start of the study (Before intervention) and 6 weeks after the start of the study (End of study)
Method of measurement
Knee alignment is measured in standing, sitting, walking, standing on one leg, and stairs position.
2
Description
Function based on questionnaire of Knee injury and Osteoarthritis Outcome Score. The score is a percentage score from 0 to 100, 0 representing extreme problems and 100 representing no problems
Timepoint
At the start of the study (Before intervention) and 6 weeks after the start of the study (End of study)
Method of measurement
The function is measured by Knee injury and Osteoarthritis Outcome Score questionnaire.
Intervention groups
1
Description
Intervention group: This group consists of patients with knee pain that are treatable with physiotherapy after initial assessment. In this group, patients are classified based on “Movement System Impairments “ (MSI) method. In this system of classification of patients, they are categorized in one of the MSI groups based on the signs and symptoms consisting of pain (primary variable) and function (secondary variable) in different positions (secondary variable). Since each group has a different characteristic in comparison to others, patients are treated based on the group they are categorized in. Treatment consists of strengthening each category. These exercises are prescribed based on the problem in each group. Moreover, the patient will be taught what to be cautious about, what to avoid, and what needs to be done in daily tasks. If there is a desire for the taping of the patellar bone to correct the patellar alignment through the treatment, it will be done, as well. Stretching exercises are another part of the exercises that might be prescribed based on necessity. These exercises are performed for 6 weeks.
Category
Rehabilitation
2
Description
Control group: This group consists of patients with knee pain that have been diagnosed as treatable by physiotherapy while they are not categorized in specific groups. Their treatment is based on routine physiotherapy exercises. The term routine physiotherapy consists of training knee pain through muscle strengthening exercises, stretching, and teaching the positions that the patient should avoid without being in a specific group. All these treatments are taught to all patients. These exercises continue for 6 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Sport Sciences. Kharazmi University
Full name of responsible person
Azam Ahmadi
Street address
No 1. Kusha St. Hesari St. Mirdamad. Shahid Keshvari Sports Complex,
City
Tehran
Province
Tehran
Postal code
1544733111
Phone
+98 21 2222 8001
Email
labrotary.pess.khu@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kharazmi University
Full name of responsible person
Dr Mohammad Delnavaz
Street address
3th floor. Faculty of sport science and Physical Education, Shahid Keshvari Sports Complex, Razan Jonobi, Mirdamad,