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Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Mulligan techniques with manual traction
McKenzie extension exercises with manual traction
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, Range of Motion, Manual Therapy, Pain, Mobilization

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age range 28-50 years Patients of both gender Clinically diagnosed patient with Lumbar radiculopathy Exclusion Criteria: Subject with chronic radicular low back pain with the history of spinal surgery Patients who have recently received corticosteroids Diagnosed cases of osteoporosis History of recent Fracture Lumber instability Trauma Inflammatory disorders Acute disc bulge

Sites / Locations

  • Jinnah Hospital Lahore, Rehab CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Arm Description

Mulligan techniques with manual traction

McKenzie extension exercises with manual traction

Outcomes

Primary Outcome Measures

NPRS
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.
Oswestry Disability Scale (ODI)
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools.
Range of Motion
Assessment of range of motion (ROM) of the lumbar spine is an important part lumbar spine examination. Range of motion will be measured with inclinometer. Aberrant spinal motion is associated with faulty spinal mechanics. Motion of the lumbar spine will be assessed in all planes including flexion, extension, side bending, and rotation. Variables affect lumbar range of motion

Secondary Outcome Measures

Full Information

First Posted
September 15, 2023
Last Updated
October 11, 2023
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT06049277
Brief Title
Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain
Official Title
Effects of Mulligan Technique Versus McKenzie Extension Exercise With Manual Traction in Patients With Chronic Unilateral Radicular Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2023 (Actual)
Primary Completion Date
February 15, 2024 (Anticipated)
Study Completion Date
March 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

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
This project will be a Randomized clinical trial conducted to determine effects of Mulligan technique versus McKenzie extension exercise with manual traction in patients with chronic unilateral radicular low back pain. Sample will be collected through non-probability convenient sampling, following eligibility criteria from Rehab Care and Jinnah Hospital Lahore. Eligibility criteria will be both gender and age range 28-50 years, clinically diagnosed patient with Lumbar radiculopathy after exclusion of the patients with Fracture, Trauma, Inflammatory disorder, acute disc bulge, Lumbar instability. Participants will be randomly allocated in two groups via sealed envelope method, baseline assessment will be done, Group A participants will be given baseline treatment along with Mulligan techniques, Group B participants will be given baseline treatment along with McKenzie protocol. Pre and post intervention assessment will be done via, Numeric pain rating scale(NPRS), Oswestry Disability Scale (ODI) and lumber Range of Motion, 2 sessions per week will be given for 4 weeks, data will be analyzed by using SPSS version 29.
Detailed Description
Chronic mechanical low back pain is common among different age groups and genders. Different manual therapy techniques combined with exercise therapy and electrotherapy modalities play an important role in its management. Our objective was to compare the effects of McKenzie extension exercises program versus Mulligan Techniques for chronic unilateral radicular low back pain. The primary objective of my study is to evaluate the outcome of Mulligan technique versus McKenzie extension exercise with manual traction in patients with chronic unilateral radicular low back pain in terms of pain reduction and ROM. A randomized control trial will be conducted at Rehab Care and Jinnah Hospital Lahore, from 1st June - 31st January 2024. Both genders and age range 28-50 years clinically diagnosed patient with Lumbar radiculopathy will be included. The patients with Fracture, Trauma, Inflammatory disorder, acute disc bulge, Lumbar instability will be excluded. Subjects will be divided into two equal groups through a computer-generated random number. Sixteen patients in group A will be treated with Mulligan techniques and Sixteen patients in group B with McKenzie for four weeks at two session per week and single session per day. Visual Analogue Scale, Oswestry Disability Scale and lumbar Range of Motion will be used as an assessment tool and were measured at baseline and at the completion 4 weeks intervention. The data will be entered and analyzed with SPSS to draw the statistical and clinical significance of both interventions. Results will be presented as mean and standard deviation for numerical variables like Visual Analogue Scale, Oswestry Disability Scale and lumber Range of Motion. Analysis will be done by statistical package for social sciences SPSS 29

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, Range of Motion, Manual Therapy, Pain, Mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
Mulligan techniques with manual traction
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
McKenzie extension exercises with manual traction
Intervention Type
Other
Intervention Name(s)
Mulligan techniques with manual traction
Intervention Description
group A will be treated with Mulligan techniques with manual traction.16 patients in group A will be treated with Mulligan Techniques SNAGS in sitting, standing and prone position by applying Antero cranial glide in the direction of treatment plane over the spinous or transverse process and Spinal mobilization with leg movement at 6 to 8 repetitions per sessions and spinal mobilization with leg movement will be performed in side lying, patient facing the physiotherapist while the leg movement may assisted by another person (Physiotherapist/assistant). Sustained transverse glide is given on the desired spinous process with 10 repetitions of offending movement in first session while 10 reps in each of 3 sets in further sessions.
Intervention Type
Other
Intervention Name(s)
McKenzie extension exercises with manual traction
Intervention Description
group B will be treated McKenzie extension exercises with manual traction.16 patients in group B will be treated with McKenzie active EEP in prone position with repeated movements along with standard protocols. McKenzie Extension Exercises performed actively in prone position. Extension exercises performed in three stages, initially patient instructed to be just lift the neck and look on front at the eye level, then progressed next and weight bearing on the elbow by lifting up the shoulder and then moved on third and final steps in which complete trunk extension is performed and weight bearing is on the hands.
Primary Outcome Measure Information:
Title
NPRS
Description
Changes from base Line Numeric Pain rating scale is a scale for pain starting from 0-10. where 0 indicate no pain and 10 indicate severe pain.
Time Frame
4th Week
Title
Oswestry Disability Scale (ODI)
Description
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools.
Time Frame
4th Week
Title
Range of Motion
Description
Assessment of range of motion (ROM) of the lumbar spine is an important part lumbar spine examination. Range of motion will be measured with inclinometer. Aberrant spinal motion is associated with faulty spinal mechanics. Motion of the lumbar spine will be assessed in all planes including flexion, extension, side bending, and rotation. Variables affect lumbar range of motion
Time Frame
4th Week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age range 28-50 years Patients of both gender Clinically diagnosed patient with Lumbar radiculopathy Exclusion Criteria: Subject with chronic radicular low back pain with the history of spinal surgery Patients who have recently received corticosteroids Diagnosed cases of osteoporosis History of recent Fracture Lumber instability Trauma Inflammatory disorders Acute disc bulge
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Imran Amjad
Phone
03324390125
Email
imran.amjad@riphah.edu.pk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syed Shakil ur Rehman
Organizational Affiliation
Riphah International University, Lahore, Pakistan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maira Saeed
Organizational Affiliation
Riphah International University, Lahore, Pakistan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jinnah Hospital Lahore, Rehab Care
City
Lahore
State/Province
Punjab
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Syed Shakil ur Rehman
Phone
0320-7866611
Email
shakil.urrehman@riphah.edu.pk
First Name & Middle Initial & Last Name & Degree
Maira Saeed

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34456042
Citation
Buran Cirak Y, Yurdaisik I, Elbasi ND, Tutuneken YE, Koce K, Cinar B. Effect of Sustained Natural Apophyseal Glides on Stiffness of Lumbar Stabilizer Muscles in Patients With Nonspecific Low Back Pain: Randomized Controlled Trial. J Manipulative Physiol Ther. 2021 Jul-Aug;44(6):445-454. doi: 10.1016/j.jmpt.2021.06.005. Epub 2021 Aug 26.
Results Reference
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PubMed Identifier
31740859
Citation
Tul Ain SQ, Shakil Ur Rehman S, Maryam M, Kiani SK. Effects of Sustained Natural Apophyseal Glides with and without thoracic posture correction techniques on mechanical back pain: a randomized control trial. J Pak Med Assoc. 2019 Nov;69(11):1584-1587. doi: 10.5455/JPMA.274875..
Results Reference
background
PubMed Identifier
27182265
Citation
Waqqar S, Shakil-Ur-Rehman S, Ahmad S. McKenzie treatment versus mulligan sustained natural apophyseal glides for chronic mechanical low back pain. Pak J Med Sci. 2016 Mar-Apr;32(2):476-9. doi: 10.12669/pjms.322.9127.
Results Reference
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PubMed Identifier
24405779
Citation
Cuesta-Vargas A, Farasyn A, Gabel CP, Luciano JV. The mechanical and inflammatory low back pain (MIL) index: development and validation. BMC Musculoskelet Disord. 2014 Jan 9;15:12. doi: 10.1186/1471-2474-15-12.
Results Reference
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PubMed Identifier
9431633
Citation
O'Sullivan PB, Phyty GD, Twomey LT, Allison GT. Evaluation of specific stabilizing exercise in the treatment of chronic low back pain with radiologic diagnosis of spondylolysis or spondylolisthesis. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2959-67. doi: 10.1097/00007632-199712150-00020.
Results Reference
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PubMed Identifier
36134056
Citation
Chitale N Jr, Patil DS, Phansopkar P, Joshi A. A Review on Treatment Approaches for Chronic Low Back Pain via Mulligans Movement With Mobilization and Physical Therapy. Cureus. 2022 Aug 18;14(8):e28127. doi: 10.7759/cureus.28127. eCollection 2022 Aug.
Results Reference
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Citation
Salik S RS, Hayaat R, Manzoor S, Malik AU, Maqbool S. Comparison of Mulligan sustained natural apophyseal glides verses Mckenzie extension exercises on disability and functional outcomes in patients with acute nonspecific low back pain. PJMHS. 2022;16(10):1:5.
Results Reference
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PubMed Identifier
18164461
Citation
May S, Donelson R. Evidence-informed management of chronic low back pain with the McKenzie method. Spine J. 2008 Jan-Feb;8(1):134-41. doi: 10.1016/j.spinee.2007.10.017.
Results Reference
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PubMed Identifier
37017272
Citation
Almeida MO, Narciso Garcia A, Menezes Costa LC, van Tulder MW, Lin CC, Machado LA. The McKenzie method for (sub)acute non-specific low back pain. Cochrane Database Syst Rev. 2023 Apr 5;4(4):CD009711. doi: 10.1002/14651858.CD009711.pub2.
Results Reference
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Mulligan Technique Versus McKenzie Extension Exercise Chronic Unilateral Radicular Low Back Pain

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