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

Primary Purpose

Mechanical Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mckenzie Extension Exercises
Sponsored by
Foundation University Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Mechanical Low Back Pain focused on measuring Physical therapy; Intervertebral disc; Magnetic resonance imaging; Low Back Pain

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fauji Foundation HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional group

Arm Description

Mckenzie Extension Exercises

Outcomes

Primary Outcome Measures

MRI changes
fatty infiltration and modic changes

Secondary Outcome Measures

Pain intensity assessed by numeric pain rating scale
Pain will be assessed by numeric pain rating scale
Disability will be assessed by Roland-Morris Low Back Pain and Disability Questionnaire (RMQ)

Full Information

First Posted
January 4, 2023
Last Updated
January 5, 2023
Sponsor
Foundation University Islamabad
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1. Study Identification

Unique Protocol Identification Number
NCT05673616
Brief Title
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

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Foundation University Islamabad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mechanical Low Back Pain
Keywords
Physical therapy; Intervertebral disc; Magnetic resonance imaging; Low Back Pain

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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 illness
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
Mckenzie Extension Exercises
Intervention Type
Other
Intervention Name(s)
Mckenzie Extension Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
MRI changes
Description
fatty infiltration and modic changes
Time Frame
At baseline and 4 weeks
Secondary Outcome Measure Information:
Title
Pain intensity assessed by numeric pain rating scale
Description
Pain will be assessed by numeric pain rating scale
Time Frame
At baseline and 4 weeks
Title
Disability will be assessed by Roland-Morris Low Back Pain and Disability Questionnaire (RMQ)
Time Frame
At baseline and 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madiha Ashfaq, DPT, MS-CPPT
Phone
+923325143479
Email
madiha.ashfaq@fui.edu.pk
First Name & Middle Initial & Last Name or Official Title & Degree
Sidra Qureshi, DPT,MS-WHPT
Phone
03338223868
Email
Sidra.qureshi@fui.edu.pk
Facility Information:
Facility Name
Fauji Foundation Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madiha Ashfaq, DPT, MS-CPPT
Phone
+923325143479
Email
madiha.ashfaq@fui.edu.pk

12. IPD Sharing Statement

Learn more about this trial

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

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