Clinical trial NCT05673616: MRI-Based Structural Changes in Lumber Spine in Subjects With Discogenic Low Back Pain After Mckenzie Exercises.
Official title: MRI-Based Structural Changes in Lumber Spine in Subjects With Discogenic Low Back Pain After Mckenzie Exercises.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mechanical Low Back Pain
Keywords: Physical therapy; Intervertebral disc; Magnetic resonance imaging; Low Back Pain
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2023-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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:

1. To determine the effects of McKenzie Mechanical Diagnosis and Therapy (MDT) on MRI-based structural changes in Pateints with mechanical low back pain.
2. To determine the effects of McKenzie MDT on Pain and Disabaility scores in patients with mechanical low back pain.
3. 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:

1. 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.
2. 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.
3. 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.

Eligibility criteria: Inclusion Criteria:

Both genders having low back pain. Patients having modic changes in MRI. Otherwise healthy patients with age range from 18 - 55 years.

Exclusion Criteria:

Patients with non-mechanical LBP Patients not meeting age range Patients with any major co-morbidity

Primary outcomes:
measure: MRI changes
timeFrame: At baseline and 4 weeks
Secondary outcomes:
measure: Pain intensity assessed by numeric pain rating scale
timeFrame: At baseline and 4 weeks
measure: Disability will be assessed by Roland-Morris Low Back Pain and Disability Questionnaire (RMQ)
timeFrame: At baseline and 4 weeks
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Fauji Foundation Hospital
state: Punjab
Study officials:
References: