Non Specific Low Back PainNCT05340894
Mckenzie Versus William Exercise for Non Specific Low Back Pain in Adolescents
A study testing MCKENZIE exercises and WILLIAM'S exercises in people with Non Specific Low Back Pain, run by Cairo University.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 18 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Non Specific Low Back Pain
- What is being tested?
- MCKENZIE exercises and WILLIAM'S exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2022to 10 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
Read more
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.
- Conditions
- Non Specific Low Back Pain
- Being tested
- MCKENZIE exercises, WILLIAM'S exercises
- Keywords
- Adolescents, Balance, Low Back Pain, McKenzie Exercises, and William's Exercises.
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCKENZIE exercisesProcedure or surgery
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
WILLIAM'S exercisesProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Mckenzie group | Active comparator | * adolescents will receive 4 weeks Mckenzie exercise program
* Follow-up:pre-test (Baseline), 2 weeks post-test and 4 weeks post-test. Receives: Procedure: MCKENZIE exercises |
| William's group | Active comparator | * adolescents will receive 4 weeks William's exercise program
* Follow-up:pre-test (Baseline), 2 weeks post-test and 4 weeks post-test. Receives: Procedure: WILLIAM'S exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: changes in pain at 4 weeks
Secondary outcomes (1)
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.
Measured: changes in back flexibility in 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start10 Oct 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion10 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Specific Low Back PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hesham Hany Mohamed Mahmoued Elmahdy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340894
- Sponsor's protocol ID
- P.T.REC/012/003327
- Status last verified
- Aug 2022
- First submitted
- 15 Mar 2022
- Last updated
- 17 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05340894
- Acronym / sponsor ID
- P.T.REC/012/003327
- Conditions
- Non Specific Low Back Pain
- Keywords
- Adolescents, Balance, Low Back Pain, McKenzie Exercises, and William's Exercises.
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Oct 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 10 Dec 2022 (estimated)
- First posted
- 22 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mckenzie group | Active comparator | Procedure: MCKENZIE exercises* adolescents will receive 4 weeks Mckenzie exercise program * Follow-up:pre-test (Baseline), 2 weeks post-test and 4 weeks post-test. |
| William's group | Active comparator | Procedure: WILLIAM'S exercises* adolescents will receive 4 weeks William's exercise program * Follow-up:pre-test (Baseline), 2 weeks post-test and 4 weeks post-test. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MCKENZIE exercisesMcKenzie 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 | Procedure or surgery | Mckenzie group |
| WILLIAM'S exercisesWilliam 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 | Procedure or surgery | William's group |
Primary outcome
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 .
1 secondary outcome
ModifiedSchober's Test(MSchober test)
Time frame: changes in back flexibility in 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing MCKENZIE exercises and WILLIAM'S exercises in people with Non Specific Low Back Pain, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analogue Scale (VAS) (time frame: changes in pain at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2022.