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

NCT ID: NCT05673616

Last Updated: 2023-01-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-09-30

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.

Conditions

Mechanical Low Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Interventional group

Mckenzie Extension Exercises

Group Type: EXPERIMENTAL

Mckenzie Extension Exercises

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fauji Foundation Hospital

Rawalpindi, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Madiha Ashfaq, DPT, MS-CPPT

Role: CONTACT

madiha.ashfaq@fui.edu.pk

+923325143479

Sidra Qureshi, DPT,MS-WHPT

Role: CONTACT

Sidra.qureshi@fui.edu.pk

03338223868

Facility Contacts

Madiha Ashfaq, DPT, MS-CPPT

Role: primary

madiha.ashfaq@fui.edu.pk

+923325143479

Other Identifiers

FUI/CTR/2022/3

Identifier Type: -

Identifier Source: org_study_id