Mckenzie Versus William Exercise for Non Specific Low Back Pain in Adolescents
Primary Purpose
Non Specific Low Back Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MCKENZIE exercises
WILLIAM'S exercises
Sponsored by
About this trial
This is an interventional treatment trial for Non Specific Low Back Pain focused on measuring Adolescents, Balance, Low Back Pain, McKenzie Exercises, and William's Exercises.
Eligibility Criteria
Inclusion Criteria:
- Age range from 14 to 18 years.
- Diagnosed as non-specific low back pain.
- Medically and clinically stable.
- All participants are within normal range weight and height.
Exclusion Criteria:
Adolescents have one or more of the followings will be excluded:
- Any spinal deformities.
- History of spinal or pelvic surgery.
- Specific spinal pathologies as cauda equina syndrome, cord compression, infection, fracture, neoplasm, inflammatory disease, whiplash associated disorders and vertebro-basilar insufficiency.
- Any visual or auditory problems that interfere with the rehabilitation program.
- Children with significant mental or psychological problems that interfere with understanding instructions.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Mckenzie group
William's group
Arm Description
adolescents will receive 4 weeks Mckenzie exercise program Follow-up:pre-test (Baseline), 2 weeks post-test and 4 weeks post-test.
adolescents will receive 4 weeks William's exercise program Follow-up:pre-test (Baseline), 2 weeks post-test and 4 weeks post-test.
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS)
This will be used to determine the intensity of pain.The VAS is a valid and reliable measure of chronic pain intensity . It is the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Operationally, a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end The patient will mark on the line at the point that he feels which represents his perception of the current state.The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the child marks .
Secondary Outcome Measures
ModifiedSchober's Test(MSchober test)
The mSchober test is frequently used method for assessing lumbar flexion range of motion (ROM).
Test will be done as follows:
The participant will stand in neutral erect position without shoes.
The assessor will marks 1 point 5 cm below and 1 point 10 cm above the lumbosacral junction(dimples of Venus), that is, 15 cm in upright position.
The participant will be asked to make 2 attempts to bend forward as far as possible, the first will be a trial attempt, and the assessor measured the distance between the marks on the second attempt
The increase in distance between the marks was then calculated as the measure of lumbar flexion ROM.
In general, the measure should increase by at least 6 cm to 21 cm. An increase of less than 6 cm suggests decreased lumbar spinal mobility.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05340894
Brief Title
Mckenzie Versus William Exercise for Non Specific Low Back Pain in Adolescents
Official Title
A Randomaized ,Double Study ,Aims to Compare Between Mckenzie and William's Exercises in Order to Find Which Method Has Better Effect on Adolescents With Non Specific Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 10, 2022 (Anticipated)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
MCKENZIE EXERCISE VERSUS WILLIAMS EXERCISE ON DECREASING PAIN IN ADOLESCENT WITH NON SPECIFIC LOW BACK PAIN
Low back pain is uncommon in the first decade of life,but prevalence increases steeply during the teenage years; around 40% of 9-18-year olds in high-income, medium-income, and low-income countries report having had low back pain. NSLBP represents about 85% of LBP patients seen in primary care. Non-specific low back pain is one of the most common health problems and is the leading cause of disability in young adults. During school age, the overall risk of low back pain is similar to adults, with prevalence rates as high as 70% to 80% by the age of 20 years old Non-specific low back pain is defined as low back pain not attributable to a recognisable, known specific pathology.
Understanding back pain in adolescents is crucial to obtain timely diagnosis and determine appropriate treatment. Proper treatment and management of LBP in the adolescent years can minimize back pain lasting into adulthood Non pharmacological treatments are emphasised over pharmacological interventions in the management of persistent non-specific low back pain.
natinal institute for health and care excellence(NICE) 2016 draft guideline endorses self-management, exercise, manual therapy, psychological therapies, combined physical and psychological programmes, return-to-work programmes, and radiofrequency denervation.
Back exercises can be an inexpensive and easy option of treatment for NSLBP and proven to be effective. McKenzie extension exercise and William flexion exercise are the most common types of back exercises.
Selection the appropriate treatment method is important. So this study will be aimed to compare between Mckenzie and William's exercises in order to find which method has better effect on adolescents with NSLBP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Specific Low Back Pain
Keywords
Adolescents, Balance, Low Back Pain, McKenzie Exercises, and William's Exercises.
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mckenzie group
Arm Type
Active Comparator
Arm Description
adolescents will receive 4 weeks Mckenzie exercise program
Follow-up:pre-test (Baseline), 2 weeks post-test and 4 weeks post-test.
Arm Title
William's group
Arm Type
Active Comparator
Arm Description
adolescents will receive 4 weeks William's exercise program
Follow-up:pre-test (Baseline), 2 weeks post-test and 4 weeks post-test.
Intervention Type
Procedure
Intervention Name(s)
MCKENZIE exercises
Intervention Description
McKenzie method is popular amongst physiotherapists as a management approach for spinal pain and McKenzie exercises for LBP are beneficial treatment for increasing flexibility of spine and improving the pain with better results in pain relief
Intervention Type
Procedure
Intervention Name(s)
WILLIAM'S exercises
Intervention Description
William flexion exercise is to reduce pain or soreness and provide lower trunk stability by actively developing the abdominal muscles,gluteus maximus and hamstring, passively stretching the hip flexors and lower back muscles(sacro spinalis) and to restore or improve the work balance between the postural flexor and extensor muscle groups
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
This will be used to determine the intensity of pain.The VAS is a valid and reliable measure of chronic pain intensity . It is the amount of pain that a patient feels ranges across a continuum from none to an extreme amount of pain. Operationally, a VAS is usually a horizontal line, 100 mm in length, anchored by word descriptors at each end The patient will mark on the line at the point that he feels which represents his perception of the current state.The VAS score is determined by measuring in millimeters from the left hand end of the line to the point that the child marks .
Time Frame
changes in pain at 4 weeks
Secondary Outcome Measure Information:
Title
ModifiedSchober's Test(MSchober test)
Description
The mSchober test is frequently used method for assessing lumbar flexion range of motion (ROM).
Test will be done as follows:
The participant will stand in neutral erect position without shoes.
The assessor will marks 1 point 5 cm below and 1 point 10 cm above the lumbosacral junction(dimples of Venus), that is, 15 cm in upright position.
The participant will be asked to make 2 attempts to bend forward as far as possible, the first will be a trial attempt, and the assessor measured the distance between the marks on the second attempt
The increase in distance between the marks was then calculated as the measure of lumbar flexion ROM.
In general, the measure should increase by at least 6 cm to 21 cm. An increase of less than 6 cm suggests decreased lumbar spinal mobility.
Time Frame
changes in back flexibility in 4 weeks
Other Pre-specified Outcome Measures:
Title
YMED TEST Balance Test
Description
This smart phone application was developed by Physio tools YMED; a group from the kwangju Health College, South Korea. It allows the performance of several tests: vestibular balance test, sitting balance test, knee balance test and board balance test .
Vestibular and board balance tests will be used as the following:
• Vestibular balance test: Smart phone device will be fixed on the patient's back by strap and he will be asked firstly to keep standing with open eyes for 10 seconds and therapist click start button then to keep standing with closed eyes for 10 seconds and wait for report of test.
• Board balance test: Patient will be asked to stand on a balance board and fix the smart phone on the board and the patient will be asked to stand steady as much as can for 10 seconds then print the reports.
Time Frame
changes in balance in 4 weeks
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
adolescents male only
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age range from 14 to 18 years.
Diagnosed as non-specific low back pain.
Medically and clinically stable.
All participants are within normal range weight and height.
Exclusion Criteria:
Adolescents have one or more of the followings will be excluded:
Any spinal deformities.
History of spinal or pelvic surgery.
Specific spinal pathologies as cauda equina syndrome, cord compression, infection, fracture, neoplasm, inflammatory disease, whiplash associated disorders and vertebro-basilar insufficiency.
Any visual or auditory problems that interfere with the rehabilitation program.
Children with significant mental or psychological problems that interfere with understanding instructions.
12. IPD Sharing Statement
Learn more about this trial
Mckenzie Versus William Exercise for Non Specific Low Back Pain in Adolescents
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