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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
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

14 Years - 18 Years (Child, Adult)MaleAccepts Healthy Volunteers

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

    First Posted
    March 15, 2022
    Last Updated
    October 14, 2022
    Sponsor
    Cairo University
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    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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