- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05340894
Mckenzie Versus William Exercise for Non Specific Low Back Pain in Adolescents
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Mckenzie group
|
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
|
ACTIVE_COMPARATOR: William's group
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS)
Time Frame: changes in pain at 4 weeks
|
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 .
|
changes in pain at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ModifiedSchober's Test(MSchober test)
Time Frame: changes in back flexibility in 4 weeks
|
The mSchober test is frequently used method for assessing lumbar flexion range of motion (ROM). Test will be done as follows:
|
changes in back flexibility in 4 weeks
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
YMED TEST Balance Test
Time Frame: changes in balance in 4 weeks
|
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. |
changes in balance in 4 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/003327
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Non Specific Low Back Pain
-
McMaster UniversityCanadian Institutes of Health Research (CIHR); University of Alberta; Laval University and other collaboratorsRecruitingNon-specific Low Back PainCanada
-
Riphah International UniversityCompletedNon-specific Low Back PainPakistan
-
University of UtahCompletedNon-specific Low Back PainUnited States
-
Obafemi Awolowo UniversityCompletedNon-specific Low Back PainNigeria
-
University of Central FloridaActive, not recruitingNon-specific Low Back PainUnited States
-
Riphah International UniversityCompletedNon-specific Low Back PainPakistan
-
Fundacion Rioja SaludHospital San PedroCompleted
-
Riphah International UniversityCompleted
-
Glostrup University Hospital, CopenhagenUniversity of Bergen; National Research Centre for the Working Environment,... and other collaboratorsCompletedNon-specific Low Back PainDenmark
-
Universiti Sains MalaysiaNot yet recruiting
Clinical Trials on MCKENZIE exercises
-
Riphah International UniversityRecruitingForward Head Posture | Neck SyndromePakistan
-
Firat UniversityRecruiting
-
Foundation University IslamabadRecruitingMechanical Low Back PainPakistan
-
Superior UniversityNot yet recruitingSacroiliac Joint Somatic DysfunctionPakistan
-
Neuro Counsel Hospital, PakistanNational Institute of Rehabilitation Medicine, Islamabad, PakistanRecruitingLumbosacral RadiculopathyPakistan
-
Riphah International UniversityRecruiting
-
Istinye UniversityCompleted
-
Back and Rehabilitation Center, CopenhagenThe Danish Rheumatism Association; Foundation for Chiropractic Research and... and other collaboratorsCompletedLow Back PainDenmark
-
Riphah International UniversityRecruitingForward Head PosturePakistan
-
Riphah International UniversityNot yet recruitingMechanical Neck PainPakistan