NCT06049277

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable low-back-pain

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2024

Completed
Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

September 15, 2023

Last Update Submit

January 28, 2024

Conditions

Keywords

Low Back PainRange of MotionManual TherapyPainMobilization

Outcome Measures

Primary Outcomes (3)

  • 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.

    4th Week

  • 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.

    4th Week

  • 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

    4th Week

Study Arms (2)

Mulligan techniques with manual traction

EXPERIMENTAL

Mulligan techniques with manual traction

Other: Mulligan techniques with manual traction

McKenzie extension exercises with manual traction

ACTIVE COMPARATOR

McKenzie extension exercises with manual traction

Other: McKenzie extension exercises with manual traction

Interventions

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.

Mulligan techniques 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.

McKenzie extension exercises with manual traction

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age range 28-50 years
  • Patients of both gender
  • Clinically diagnosed patient with Lumbar radiculopathy

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Hospital Lahore, Rehab Care

Lahore, Punjab Province, Pakistan

Location

Related Publications (9)

  • 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.

    PMID: 34456042BACKGROUND
  • 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..

    PMID: 31740859BACKGROUND
  • 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.

    PMID: 27182265BACKGROUND
  • 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.

    PMID: 24405779BACKGROUND
  • 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.

    PMID: 9431633BACKGROUND
  • 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.

    PMID: 36134056BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 18164461BACKGROUND
  • 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.

    PMID: 37017272BACKGROUND

MeSH Terms

Conditions

Low Back PainPain

Condition Hierarchy (Ancestors)

Back PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Syed Shakil ur Rehman

    Riphah International University, Lahore, Pakistan

    PRINCIPAL INVESTIGATOR
  • Maira Saeed

    Riphah International University, Lahore, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2023

First Posted

September 22, 2023

Study Start

September 25, 2023

Primary Completion

January 10, 2024

Study Completion

January 15, 2024

Last Updated

January 30, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations