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

Sponsor
Foundation University Islamabad (Other)
Overall Status
Recruiting
CT.gov ID
NCT05673616
Collaborator
(none)
40
1
1
7
5.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mckenzie Extension Exercises
N/A

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.

  1. 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.

  2. 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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Inclusion Criteria Patients having Discogenic LBP referred from hospital. Male and female both Ptients hving Modic changes in MRI. 3.Otherwise, healthy patients with age range from 18 to 55 years. Exclusion criteria: Patients with non-mechanical LBP Patients not meeting age range Patients with any major co-morbidity Any type of systemic illnessInclusion Criteria Patients having Discogenic LBP referred from hospital. Male and female both Ptients hving Modic changes in MRI. 3.Otherwise, healthy patients with age range from 18 to 55 years.Exclusion criteria:Patients with non-mechanical LBP Patients not meeting age range Patients with any major co-morbidity Any type of systemic illness
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
MRI-Based Structural Changes in Lumber Spine in Subjects With Discogenic Low Back Pain After Mckenzie Exercises.
Anticipated Study Start Date :
Feb 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Interventional group

Mckenzie Extension Exercises

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.

Outcome Measures

Primary Outcome Measures

  1. MRI changes [At baseline and 4 weeks]

    fatty infiltration and modic changes

Secondary Outcome Measures

  1. Pain intensity assessed by numeric pain rating scale [At baseline and 4 weeks]

    Pain will be assessed by numeric pain rating scale

  2. Disability will be assessed by Roland-Morris Low Back Pain and Disability Questionnaire (RMQ) [At baseline and 4 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fauji Foundation Hospital Rawalpindi Punjab Pakistan 46000

Sponsors and Collaborators

  • Foundation University Islamabad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Foundation University Islamabad
ClinicalTrials.gov Identifier:
NCT05673616
Other Study ID Numbers:
  • FUI/CTR/2022/3
First Posted:
Jan 6, 2023
Last Update Posted:
Jan 6, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Foundation University Islamabad
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 6, 2023