Determining the effect of McKenzie and Williams exercise on chronic back pain in the elderly referring to Imam Hospital in Ilam
Design
We'll use a permutation block of six to ensure unbiased random allocation. The block will be divided into three groups of 34, with each sample having an equal chance of being selected. We'll prepare six sheets of paper, two with W, two with M, and two with C. One sheet will be drawn randomly for each qualified person, assigning them to one of two intervention groups or a control group. After all six cards are drawn, they'll be returned to the table and the process will be repeated until the desired sample size is reached.
Settings and conduct
Imam Khomeini Hospital
Participants/Inclusion and exclusion criteria
Age range from 60 to 75 years
At least 3 months have passed since the person's back pain
His chronic back pain should be of a non-specific type and should be confirmed by an orthopedic specialist
Not having rheumatic diseases through asking the patient and confirmation from the doctor
Intervention groups
Mackenzie: McKenzie's exercise is to teach pain management and treatment methods to patients with back pain or neck pain using exercise and other strategies so that patients can heal themselves and relieve their pain throughout their lives.
Williams: Theoretical definition: Williams exercise is the name of a group of soft movements that are used in the prevention and treatment of back pain.
Main outcome variables
Study to measure chronic back pain in elderly before, during, and after intervention. Compares Williams test group with control group.
Compare chronic back pain in elderly pre- and post-intervention, 8 weeks after start, and 1 week after end. McKenzie vs Williams group.
Determining the relationship between background variables and the amount of chronic back pain in the elderly referring to Imam Hospital in Ilam
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240225061107N1
Registration date:2024-03-22, 1403/01/03
Registration timing:registered_while_recruiting
Last update:2024-03-22, 1403/01/03
Update count:0
Registration date
2024-03-22, 1403/01/03
Registrant information
Name
Parisa Yousefi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 918 990 0898
Email address
yousefi-p@medilam.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-10, 1402/12/20
Expected recruitment end date
2024-06-30, 1403/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The evaluation of the effect of Mackenzie and Williams exercise on chronic back pain in the elderly
Public title
The Evaluation of the effect of Mckenzie and Williams exercises on chronic back pain
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
women
60 - 75 years
Not doing other sports
Living in Ilam city
Having a smart phone
Ability to read and write
Willingness to participate in the study
Availability
At least 3 months have passed since the back pain
His chronic back pain should be non-specific and should be confirmed by an orthopedic specialist
Not having rheumatic diseases through asking the patient and confirmation by the doctor
No history of cancer
Absence of severe deformity and congenital deformity of the spine, fracture and tumor, high blood pressure
Not taking anti-inflammatory and pain-relieving drugs
History of osteoporosis
Obtaining a score of 24 and above in the psychological status questionnaire
Having a doctor's certificate about being free to do the mentioned sports
Exclusion criteria:
Age
From 60 years old to 75 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
102
Randomization (investigator's opinion)
Randomized
Randomization description
After the diagnostic interview by the researcher and identifying the elderly who meet the entry criteria, 102 elderly are selected based on available sampling. In this way, patients in the age group of 60 to 75 years, who visited the clinic and met the study entry criteria, were selected and after explaining the research objectives and obtaining the patient consent, they will be selected as samples, and then randomly allocated from the block. A permutation of six will be used, which will be allocated to three groups of 34 Williams, 34 Mackenzie, and 34 control so that each sample has the same chance of being selected in each of the groups. For this purpose, six identical sheets of paper will be prepared on two sheets the letter W means Williams, on two sheets the letter M means Mackenzie, and on the other two sheets the letter C means to control or without intervention and we mix the sheets and place them on the table and refer to Each of the eligible people will be randomly drawn from one of the sheets and will be assigned to one of the two intervention groups or the control group based on it (W or M or C). It should be noted that the drawn cards will not be returned to the table until all six cards have been drawn. After randomly pulling out all six cards, all the cards will return to the table and the above process will continue for the next six observers until the desired sample size is reached.
Blinding (investigator's opinion)
Not 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 Ilam University of Medical Sciences
Street address
Shahriar St , Taamirkari Blvd.
City
Ilam
Province
Ilam
Postal code
6931355372
Approval date
2024-01-10, 1402/10/20
Ethics committee reference number
IR.MEDILAM.REC.1402.208
Health conditions studied
1
Description of health condition studied
chronic Back pain
ICD-10 code
M99.3
ICD-10 code description
Osseous stenosis of neural canal
Primary outcomes
1
Description
1. Determining the amount of chronic back pain in the elderly before the intervention, eight weeks after the start of the intervention and 72 hours after and one week after the intervention between the Mackenzie test and the control group 2. Determining the amount of chronic back pain in the elderly before the intervention, eight weeks after the start of the intervention and 72 hours After and one week after the end of the intervention between the Williams test group and the control group 3. Comparison of chronic back pain in the elderly before the intervention, eight weeks after the start of the intervention and 72 hours later and one week after the end of the intervention between the McKenzie test group and the Williams test group 4. Determination The relationship between background variables and the amount of chronic back pain in the elderly referring to Imam Hospital in Ilam
Timepoint
Before the start of the intervention, eight weeks after the start of the intervention 72 hours later, and one week after the intervention
Method of measurement
Demographic Information Questionnaire, Quebec Pain Questionnaire, Short Psychological Evaluation Questionnaire (MMSE)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Mackenzie: Theoretical definition: Mackenzie exercise is to teach the method of treatment and pain management using exercise and other strategies to patients with back pain or neck pain so that patients can treat themselves throughout their life and relieve their pain. Practical definition: In this study, the number of 36 sessions for twelve weeks and three days a week for forty-five minutes, Mackenzie's exercise program will be implemented, including three parts: warm-up, main exercise program and cool-down. First step: sleeping on the stomach, up. Bringing the trunk on the elbows and arms lower or placed under the shoulders, head down or turned to one side and take a deep breath and stay in this position for five minutes. Second step: lying on the stomach with a pillow under the chest. and the elbows are on both sides of the pillow just below the chest. Turn your head down or to the sides and take a deep breath and it takes five minutes. Third step: lying on your stomach and placing your elbows under your shoulders and resting on your forearms. Fourth step: lying on your stomach and placing your palms on the floor below. Shoulders and straightening the elbows slowly while keeping the lower body still and raising the waist as far as the pain allows. Find the neutral pelvis fan: contract the abdominal muscles and pull the navel muscles in and straighten your back and make the sound of the snake. Say the word "sssss" and try to pull out the towel under the waist with your hands, and a proper contraction will prevent the towel from pulling out. And then stretch the opposite arms and legs, keep the hips level and avoid back extension. Stay. - Superman: lie on your stomach and stretch your arms and legs. Arms should be along the ears and hold for ten seconds. Avoid overstretching the back. Place the paddle on the ground. Put your hands along the body and slowly raise your hips and hold for 5 seconds.
Category
Rehabilitation
2
Description
Intervention group: Williams theoretical definition: Williams exercise is the name of a group of soft movements that are used in the prevention and treatment of back pain. Practical definition: In this study, the number of 36 sessions for twelve weeks and three days a week for forty-five minutes of Williams training program will be implemented including three sections: warm-up, main training program and cooling down. Two knees to the stomach, thigh flexor stretch, squats. Leaning exercises: lie on your back and fold the knee into the chest. Pelvis: Lie on your back and bend your knees, the soles of your feet should be on the ground, and straighten the small of your back towards the ground and hold for 5-10 seconds. The soles of the feet are bent on the ground and the upper body is raised behind the head so that the shoulder is separated from the ground and pressure is placed on the right abdominal muscles, and after returning to the previous position, this movement is repeated. Knee to chest: Lie on your back. and fold the knee into the chest and bring it closer to your shoulder and hold for 5 to 10 seconds. Lower the knee and repeat with the other knee. Double knee to the chest: As in the previous exercise, bring both knees into the chest. and collect it towards the shoulders and hold for 5 to 10 seconds, slowly lowering one para each time. He pulls towards his head so that the pelvis goes into flexion. Standing lunges: the athlete does a front lunge in a standing position and opens his legs shoulder-width apart, then takes a step forward with his right foot and plants the para and keeps the body relatively straight. The knee should stay on the ankle and not be stretched on the toes to minimize the pressure on the knee joint. Seated trunk flexion: done by sitting on a chair and stretching the body forward in a lying position. Full squat: legs as wide as possible. Shoulders open and lumbar spine rounded in flexion. After reaching maximum depth, thrust hips up and down 15 to 20 times with 2 to 3 inches of movement per jump, then repeat 3 to 4 times. .
Category
Rehabilitation
3
Description
Control group: They do not receive any of the interventions.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Parisa Yousefi
Street address
Shahriar St , Taamirkari Blvd.
City
Ilam
Province
Ilam
Postal code
6931355372
Phone
+98 84 3222 6838
Email
yousefi-p@medilam.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Mosayeb mozafari
Street address
Ilam-Banganjab, Research Blvd., Ilam Medical Sciences University Campus
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
info@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ilam 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
Ilam University of Medical Sciences
Full name of responsible person
Parisa yousefi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahriar St , Taamirkari Blvd.
City
Ilam
Province
Ilam
Postal code
6931355372
Phone
+98 918 990 0898
Email
yousefi-p@medilam.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Parisa yousefi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahriar St , Taamirkari Blvd.
City
Ilam
Province
Ilam
Postal code
6931355372
Phone
+98 918 990 0898
Email
yousefi-p@medilam.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Parisa yousefi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahriar St , Taamirkari Blvd.
City
Ilam
Province
Ilam
Postal code
6931355372
Phone
+98 918 990 0898
Email
yousefi-p@medilam.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
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The informed consent form will be provided to the samples before entering the study.
When the data will become available and for how long
3 months
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Use in education, rehabilitation and counseling
From where data/document is obtainable
yousefi-p@medilam.ac.ir
What processes are involved for a request to access data/document