Protocol summary

Study aim
The effect Movement Pattern Training on pain muscle activity response and selected landing kinematic in men With (CLBP).
Design
patients with chronic low back pain were randomized into a treatment (MPT) group or a control (wait-list) group. The MPT program included 6 one-hour supervised sessions and incorporated (1) task-specific training for basic functional tasks and symptom-provoking tasks, and (2) strengthening of hip musculature. With parallel groups, a blind strain was performed on 50 patients. The control (wait-list) group received no treatment.
Settings and conduct
subjects performed will 0.30-m single leg landings. Trunk muscle activity will assessed using a 8-lead EMG set-up. Knee kinematics will measured using a Electrogonimeter for extension-flexion, Addaction and Abdaction were calculated of the during landing. The assessments will completed in pre-test and after six weeks.
Participants/Inclusion and exclusion criteria
Inclusion criteria included:Low back pain more than three months;Exclusion criteria for group were: spondylolisthesis or spondylolysis, ankylosing spondylitis, moderate to severe spinal osteoarthritis, inflammatory arthritis, physically active, nerve root compression, trunk neuromuscular disease, scoliosis (15˚ or more), previous spinal surgery, malignant tumour, hypertension. degenerative or inflammatory diseases of the lumbar spine. Subjects were excluded if they had received specialized training in jumping and landing techniques, such as through participation in gymnastics or dance
Intervention groups
wxpremental group:The MPT program included 6 one-hour supervised sessions and incorporated (1) task-specific training for basic functional tasks and symptom-provoking tasks, and (2) strengthening of hip musculature. control group: trunk muscle activity, pain, and kinematics of landing during single leg landing
Main outcome variables
Decrease low back pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181024041444N1
Registration date: 2021-02-16, 1399/11/28
Registration timing: retrospective

Last update: 2021-02-16, 1399/11/28
Update count: 0
Registration date
2021-02-16, 1399/11/28
Registrant information
Name
Afshin Orouji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3335 6401
Email address
std_afshinorouji@khu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-20, 1398/02/30
Expected recruitment end date
2019-07-06, 1398/04/15
Actual recruitment start date
2019-07-21, 1398/04/30
Actual recruitment end date
2019-09-06, 1398/06/15
Trial completion date
2019-12-31, 1398/10/10
Scientific title
The effect Movement-Pattern Training on pain، muscle activity response and selected landing kinematic variables in people with Non-specific chronic low back pain
Public title
The effect Movement-Pattern Training on pain، muscle activity response and selected landing kinematic variables
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Low back pain for more than 3 months
Exclusion criteria:
spondylolisthesis or spondylolysis ankylosing spondylitis moderate to severe spinal osteoarthritis, inflammatory arthritis physically active nerve root compression trunk neuromuscular disease scoliosis (15˚ or more) previous spinal surgery, malignant tumour hypertension degenerative or inflammatory diseases of the lumbar spine
Age
From 8 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 60
Actual sample size reached: 35
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization Following the initial screening and collection of labs, all study subjects started therapy within 3 days of baseline measurements. A study investigator, who did not perform any clinical measurements on study subjects, used a coin-flip to randomly assign study subjects to either the experimental control groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data Analyzer were blind before and after the experiment.In a way that did not explain to them which control group and which experimental group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti University
Street address
Tehran - Ghods Town (West), between South Flamek and Zarafshan, Iran TV St. - Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-06-23, 1397/04/02
Ethics committee reference number
https://ethics.research.ac.ir/IR.SBU.REC.1399.060

Health conditions studied

1

Description of health condition studied
Low back pain
ICD-10 code
ICD-10 code description
کمردرد

Primary outcomes

1

Description
Visual Analogue Scale
Timepoint
Before intervention، after 45 days after intervention، 45 days after the intervention
Method of measurement
Pain Quebeck Questionnaire

2

Description
Landing degree
Timepoint
Before intervention، after 45 days after intervention،45 days after the intervention
Method of measurement
Electrogoniametr

3

Description
muscle response
Timepoint
Before intervention، after 45 days after intervention،45 days after the intervention
Method of measurement
Electromyography

Secondary outcomes

1

Description
Intervention group: The movement pattern exercises are taught in the first week of the correct training of movements in everyday activities, including walking, sitting, standing, walking up and down, and proper daily routine exercises, and from the second to the fourth week of the boost muscle, each The exercises have 5 steps from easy to hard. If you do not have a feeling of pain, you should do the 4 th and 5 th steps using Teraband, which include (20 to 10 repetitions of 2 sets), the second week to strengthen the flexors, Third week strengthen the extensor muscles of the thigh, fourth week strengthen muscle of the abductor, fifth week, strengthen the muscles of the catheter, And the sixth week to strengthen the complexion of the thigh muscles
Timepoint
After the test steps for 45 days
Method of measurement
Movement pattern training

2

Description
Without intervention - Based on ethics in research after the end of interventions for such as intervention group
Timepoint
For 45 days after the end of the interventions
Method of measurement
Movement pattern training

Intervention groups

1

Description
Intervention group: All the intervention group underwent a total of 21 supervised training sessions,over a 6-week period The MPT program incorporated 2 primary components,including (1) task-specific training for basic functional tasks 6 supervised in the week 1 For the task-specific training, all patients received standard instructions, to optimize their movement pattern during basic dailytasks, such as ascending stairs and sit to stand.(2):2-6 weeks:Strengthen thigh muscles.
Category
Rehabilitation

2

Description
Control group: Normal daily activity
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
University Mohaghegh Ardebil
Full name of responsible person
Amirali jafarneghad gero
Street address
Univresity Blvd
City
Ardebil
Province
Ardabil
Postal code
5613393595
Phone
+98 45 3150 5649
Email
amiralijafarnezhad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University Of Kharazmi
Full name of responsible person
Amir letafatkar
Street address
Mirdamad Blvd
City
Tehran
Province
Tehran
Postal code
5616693595
Phone
+98 21 6854 5565
Email
letafatkaramir@yahoo.co
Grant name
The university of kharazmi
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University Of Kharazmi
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
The University of Mohagheghe Ardabili
Full name of responsible person
Amirali jafarneghad gero
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Biomechanics
Street address
university Blvd
City
Ardabil
Province
Ardabil
Postal code
5616693595
Phone
+98 45 3335 6401
Email
amiralijafarnezhad@gmail.com‏

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Mohagheghe Ardabili
Full name of responsible person
Amiralijafarneghadgero
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Biomechanics
Street address
University Blvd
City
Ardabil
Province
Ardabil
Postal code
5616693595
Phone
+98 45 3335 6401
Email
amiralijafarnezhad@gmail.com‏
Web page address
https://fa.www.irct.ir

Person responsible for updating data

Contact
Name of organization / entity
The university of Mohagheghe Ardabili
Full name of responsible person
Amirali jafarneghadgero
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports Biomechanics
Street address
University Blvd
City
Ardabil
Province
Ardabil
Postal code
5616693595
Phone
+98 45 3335 6401
Email
amiralijafarnezhad@gmail.com‏
Web page address
https://fa.irct.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Intervention program protocol file and data analysis information through publication in dissertation or article writing
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The research team of this study and other scientific and clinical researchers who do research for the benefit of these patients
Under which criteria data/document could be used
Researchers who intend to use data in writing a meta-analysis or systematic article
From where data/document is obtainable
afshiinorouji@gmail.com
What processes are involved for a request to access data/document
Their request will be answered after the approval of the academic institution
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