Clinical trial NCT06049277: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Range of Motion
Manual Therapy
Pain
Mobilization
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2023-09-22
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: NPRS
timeFrame: 4th Week
measure: Oswestry Disability Scale (ODI)
timeFrame: 4th Week
measure: Range of Motion
timeFrame: 4th Week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah Hospital Lahore, Rehab Care
state: Punjab
Study officials:
affiliation: Riphah International University, Lahore, Pakistan
name: Syed Shakil ur Rehman
role: PRINCIPAL_INVESTIGATOR
affiliation: Riphah International University, Lahore, Pakistan
name: Maira Saeed
role: PRINCIPAL_INVESTIGATOR
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