Mechanical Low Back PainNCT05673616
MRI-Based Structural Changes in Lumber Spine in Subjects With Discogenic Low Back Pain After Mckenzie Exercises.
A study testing Mckenzie Extension Exercises in people with Mechanical Low Back Pain, run by Foundation University Islamabad at 1 site in Pakistan.
Trial summary
In the rehabilitation department, we are working with patients of low back pain for routine management and as well as for research. Still now, the biomechanical ground proofing the beneficial effects of McKenzie Mechanical diagnosis and therapy on non-mechanical low back pain has not been studied in depth. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Mechanical Low Back Pain
- What is being tested?
- Mckenzie Extension Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2023to Sep 2023
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders having low back pain. Patients having modic changes in MRI. Otherwise healthy patients with age range from 18 - 55 years.
Who cannot join
- Patients with non-mechanical LBP Patients not meeting age range Patients with any major co-morbidity
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Fauji Foundation Hospital
Rawalpindi, Punjab Province, 46000
Madiha Ashfaq, DPT, MS-CPPT, +923325143479, madiha.ashfaq@fui.edu.pk
About this study
In the rehabilitation department, we are working with patients of low back pain for routine management and as well as for research. Still now, the biomechanical ground proofing the beneficial effects of McKenzie Mechanical diagnosis and therapy on non-mechanical low back pain has not been studied in depth. This qausi-experimental study will provide expert-level evidence using gold standard MRI findings to add McKenzie MDT in routine treatment of the condition.
Read the detailed description
OBJECTIVES:
The objectives of this study will be:
- To determine the effects of McKenzie Mechanical Diagnosis and Therapy (MDT) on MRI-based structural changes in Pateints with mechanical low back pain.
- To determine the effects of McKenzie MDT on Pain and Disabaility scores in patients with mechanical low back pain.
- To determine the effects of McKenzie MDT on Disabaility scores in patients with mechanical low back pain.
HYPOTHESIS:
Alternate Hypothesis:
The Mckenzie MDT will be effective in improving the MRI-based structural changes, pain and disability caused by the mechanical low back pain.
Null Hypothesis:
The Mckenzie MDT will not be effective in improving the MRI-based structural changes, pain and disability caused by the mechanical low back pain.
Research Design: Quasi - experimental Study.
Clinical setting: Foundation University College of Physical Therapy, Foundation University Islamabad.
Study duration: 12 months
Sampling technique: Non-probability Purposive sampling
Intervention to be given
After assessing the patient for eligibility, following intervention regime will be followed:
- st consultation-Day 1: In standing right side gliding will be repeated for ten to twenty times. Afterwards, extension will be repeated in lying position for ten to twenty times. The protocol will be repeated after every three hours.
- nd consultation- Day 3: Extension will be repeated in lying position for ten to twenty times. The protocol will be repeated after every three hours.
- rd consultation- Day 15: After two weeks of initial consultation, the patient will be taught to perform slouch-overcorrect on day 1 followed by flexion on day 2 in lying position and accompanied by flexion for 5 days in sitting position and finally flexion in standing will be performed.
The exercises will be repeated for 10 times and followed by extension in standing exercises.
Significance:
McKenzie mechanical diagnosis and therapy (MDT) is more effective than other therapeutic physiotherapies. But, the biomechanical ground proofing of the beneficial effects of MDT on non-mechanical low back pain has not been studied in depth. This gap will be filled by the gold standard MRI imaging technology that allows non-invasive and more detailed view of intervertebral disc. This study will emphasize the healthcare practitioners regarding the cellular level benefits of said intervention and hence decrease the surgical cost by early treatment through physical therapy and rehabilitation.
This study will emphasize the healthcare practitioners regarding the cellular level benefits of said intervention and hence decrease the surgical cost by early treatment through physical therapy and rehabilitation.
- Conditions
- Mechanical Low Back Pain
- Being tested
- Mckenzie Extension Exercises
- Keywords
- Physical therapy; Intervertebral disc; Magnetic resonance imaging; Low Back Pain
- 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 Extension ExercisesOther
After two weeks of initial consultation, the patient will be taught to perform slouch-overcorrect on day 1 followed by flexion on day 2 in lying position and accompanied by flexion for 5 days in sitting position and finally flexion in standing will be performed.
The exercises will be repeated for 10 times and followed by extension in standing exercises.
| Study group | Role | What they receive |
|---|---|---|
| Interventional group | Experimental | Mckenzie Extension Exercises Receives: Other: Mckenzie Extension Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI changes
fatty infiltration and modic changes
Measured: At baseline and 4 weeks
Secondary outcomes (2)
Pain intensity assessed by numeric pain rating scale
Pain will be assessed by numeric pain rating scale
Measured: At baseline and 4 weeks
Disability will be assessed by Roland-Morris Low Back Pain and Disability Questionnaire (RMQ)
Measured: At baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2023
- Study start1 Feb 2023 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Low Back PainStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Inclusion Criteria 1. Patients having Discogenic LBP referred from hospital. 2. Male and female both 3. Ptients hving Modic changes in MRI. 3.Otherwise, healthy patients with age range from 18 to 55 years. Exclusion criteria: 1. Patients with non-mechanical LBP 2. Patients not meeting age range 3. Patients with any major co-morbidity 4. Any type of systemic illness
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05673616
- Sponsor's protocol ID
- FUI/CTR/2022/3
- Status last verified
- Jan 2023
- First submitted
- 4 Jan 2023
- Last updated
- 6 Jan 2023
- 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 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-Based Structural Changes in Lumber Spine in Subjects With Discogenic Low Back Pain After Mckenzie Exercises.
- ClinicalTrials.gov ID
- NCT05673616
- Acronym / sponsor ID
- FUI/CTR/2022/3
- Conditions
- Mechanical Low Back Pain
- Keywords
- Physical therapy; Intervertebral disc; Magnetic resonance imaging; Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Foundation University IslamabadUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 6 Jan 2023 (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.
In the rehabilitation department, we are working with patients of low back pain for routine management and as well as for research. Still now, the biomechanical ground proofing the beneficial effects of McKenzie Mechanical diagnosis and therapy on non-mechanical low back pain has not been studied in depth. This qausi-experimental study will provide expert-level evidence using gold standard MRI findings to add McKenzie MDT in routine treatment of the condition.
Detailed description
OBJECTIVES:
The objectives of this study will be:
- To determine the effects of McKenzie Mechanical Diagnosis and Therapy (MDT) on MRI-based structural changes in Pateints with mechanical low back pain.
- To determine the effects of McKenzie MDT on Pain and Disabaility scores in patients with mechanical low back pain.
- To determine the effects of McKenzie MDT on Disabaility scores in patients with mechanical low back pain.
HYPOTHESIS:
Alternate Hypothesis:
The Mckenzie MDT will be effective in improving the MRI-based structural changes, pain and disability caused by the mechanical low back pain.
Null Hypothesis:
The Mckenzie MDT will not be effective in improving the MRI-based structural changes, pain and disability caused by the mechanical low back pain.
Research Design: Quasi - experimental Study.
Clinical setting: Foundation University College of Physical Therapy, Foundation University Islamabad.
Study duration: 12 months
Sampling technique: Non-probability Purposive sampling
Intervention to be given
After assessing the patient for eligibility, following intervention regime will be followed:
- st consultation-Day 1: In standing right side gliding will be repeated for ten to twenty times. Afterwards, extension will be repeated in lying position for ten to twenty times. The protocol will be repeated after every three hours.
- nd consultation- Day 3: Extension will be repeated in lying position for ten to twenty times. The protocol will be repeated after every three hours.
- rd consultation- Day 15: After two weeks of initial consultation, the patient will be taught to perform slouch-overcorrect on day 1 followed by flexion on day 2 in lying position and accompanied by flexion for 5 days in sitting position and finally flexion in standing will be performed.
The exercises will be repeated for 10 times and followed by extension in standing exercises.
Significance:
McKenzie mechanical diagnosis and therapy (MDT) is more effective than other therapeutic physiotherapies. But, the biomechanical ground proofing of the beneficial effects of MDT on non-mechanical low back pain has not been studied in depth. This gap will be filled by the gold standard MRI imaging technology that allows non-invasive and more detailed view of intervertebral disc. This study will emphasize the healthcare practitioners regarding the cellular level benefits of said intervention and hence decrease the surgical cost by early treatment through physical therapy and rehabilitation.
This study will emphasize the healthcare practitioners regarding the cellular level benefits of said intervention and hence decrease the surgical cost by early treatment through physical therapy and rehabilitation.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Inclusion Criteria 1. Patients having Discogenic LBP referred from hospital. 2. Male and female both 3. Ptients hving Modic changes in MRI. 3.Otherwise, healthy patients with age range from 18 to 55 years. Exclusion criteria: 1. Patients with non-mechanical LBP 2. Patients not meeting age range 3. Patients with any major co-morbidity 4. Any type of systemic illness
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Mckenzie Extension ExercisesMckenzie Extension Exercises |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Both genders having low back pain. Patients having modic changes in MRI. Otherwise healthy patients with age range from 18 - 55 years.
Key exclusion criteria (1 listed)
- Patients with non-mechanical LBP Patients not meeting age range Patients with any major co-morbidity
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 Extension ExercisesAfter two weeks of initial consultation, the patient will be taught to perform slouch-overcorrect on day 1 followed by flexion on day 2 in lying position and accompanied by flexion for 5 days in sitting position and finally flexion in standing will be performed. The exercises will be repeated for 10 times and followed by extension in standing exercises. | Other | Interventional group |
Primary outcome
MRI changes
Time frame: At baseline and 4 weeks
fatty infiltration and modic changes
2 secondary outcomes
Pain intensity assessed by numeric pain rating scale
Time frame: At baseline and 4 weeks
Disability will be assessed by Roland-Morris Low Back Pain and Disability Questionnaire (RMQ)
Time frame: At baseline and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mckenzie Extension Exercises in people with Mechanical Low Back Pain, run by Foundation University Islamabad at 1 site in Pakistan.
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 1 inclusion and 1 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 6 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Madiha Ashfaq, DPT, MS-CPPT (+923325143479, madiha.ashfaq@fui.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI changes (time frame: At baseline and 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 6 Jan 2023; AzTrials last refreshed its copy on 29 Oct 2026.