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

Sponsor

Riphah International University (Other)

Overall Status

Recruiting

CT.gov ID

NCT06049277

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

5.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain	Other: baseline physical therapy treatment along with Mulligan techniques with manual traction protocol. Other: baseline physical therapy treatment along with McKenzie extension exercises with manual traction	N/A

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. We will include patients of both genders and age range 28-50 years clinically diagnosed patient with Lumbar radiculopathy. 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Mulligan Technique Versus McKenzie Extension Exercise With Manual Traction in Patients With Chronic Unilateral Radicular Low Back Pain

Actual Study Start Date :

Sep 15, 2023

Anticipated Primary Completion Date :

Feb 15, 2024

Anticipated Study Completion Date :

Mar 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mulligan techniques with manual traction baseline physical therapy treatment along with Mulligan techniques with manual traction protocol	Other: baseline physical therapy treatment along with Mulligan techniques with manual traction protocol. 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.
Active Comparator: McKenzie extension exercises with manual traction baseline physical therapy treatment along with McKenzie extension exercises with manual traction	Other: baseline physical therapy treatment along with McKenzie extension exercises with manual traction 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.

Arm

Intervention/Treatment

Experimental: Mulligan techniques with manual traction

baseline physical therapy treatment along with Mulligan techniques with manual traction protocol

Other: baseline physical therapy treatment along with Mulligan techniques with manual traction protocol.

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.

Active Comparator: McKenzie extension exercises with manual traction

baseline physical therapy treatment along with McKenzie extension exercises with manual traction

Other: baseline physical therapy treatment along with McKenzie extension exercises with manual traction

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.

Outcome Measures

Primary Outcome Measures

NPRS [4th Week]
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) [4th Week]
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 [4th Week]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jinnah Hospital Lahore, Rehab Care	Lahore	Punjab	Pakistan

Sponsors and Collaborators

Riphah International University

Investigators

Principal Investigator: Syed Shakil ur Rehman, Riphah International University, Lahore, Pakistan
Principal Investigator: Maira Saeed, Riphah International University, Lahore, Pakistan