MRI-Based Structural Changes in Lumber Spine in Subjects With Discogenic Low Back Pain After Mckenzie Exercises.

Mechanical Low Back Pain Clinical Trial

Official title:

MRI-Based Structural Changes in Lumber Spine in Subjects With Discogenic Low Back Pain After Mckenzie Exercises.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05673616
• Other study ID #: FUI/CTR/2022/3
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: September 2023

Study information

• Verified date: January 2023
• Source: Foundation University Islamabad
• Contact: Madiha Ashfaq, DPT, MS-CPPT
• Phone: +923325143479
• Email: madiha.ashfaq[@]fui.edu.pk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. This qausi-experimental study will provide expert-level evidence using gold standard MRI findings to add McKenzie MDT in routine treatment of the condition.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Mechanical Low Back Pain

Intervention

Other:
• Mckenzie Extension Exercises
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.

Locations

Country	Name	City	State
Pakistan	Fauji Foundation Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Foundation University Islamabad

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI changes	fatty infiltration and modic changes	At baseline and 4 weeks
Secondary	Pain intensity assessed by numeric pain rating scale	Pain will be assessed by numeric pain rating scale	At baseline and 4 weeks
Secondary	Disability will be assessed by Roland-Morris Low Back Pain and Disability Questionnaire (RMQ)		At baseline and 4 weeks