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

• ClinicalTrials.gov Identifier: NCT06049277
• Recruitment Status: Completed
• First Posted: September 22, 2023
• Last Update Posted: January 30, 2024
• Sponsor: Riphah International University
• Information provided by (Responsible Party): Riphah International University

Tracking Information

• First Submitted Date: September 15, 2023
• First Posted Date: September 22, 2023
• Last Update Posted Date: January 30, 2024
• Actual Study Start Date: September 25, 2023
• Actual Primary Completion Date: January 10, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 15, 2023)

• NPRS [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Low Back Pain

Intervention

• Other: Mulligan techniques with manual traction
  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.
• Other: 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.

Study Arms

• Experimental: Mulligan techniques with manual traction
  Mulligan techniques with manual traction
  Intervention: Other: Mulligan techniques with manual traction
• Active Comparator: McKenzie extension exercises with manual traction
  McKenzie extension exercises with manual traction
  Intervention: Other: McKenzie extension exercises with manual traction

Publications *

• 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.
• 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..
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 15, 2023): 32
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 15, 2024
• Actual Primary Completion Date: January 10, 2024 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Pakistan

Administrative Information

• NCT Number: NCT06049277
• Other Study ID Numbers: REC/RCR&AHS/23/0133 Maira
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Riphah International University
• Original Responsible Party: Same as current
• Current Study Sponsor: Riphah International University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Riphah International University
• Verification Date: January 2024