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Investigation of Immediate, Short and Long Term Effects of Mulligan Mobilization With Movement Techniques in Nonspesific Chronic Low Back Pain

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mulligan mobilization with movement
Sponsored by
Suleyman Demirel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Having 3 months' continuous or intermittent LBP symptoms, without leg pain above the knee
  • Pain at VAS > 3/10,
  • Back pain increased by active lumbar flexion movement

Exclusion Criteria:

  • Confirmed nerve root compression
  • Neurological symptoms
  • Lumbar spine stenosis
  • Back surgery history
  • Chronic pain syndrome
  • LBP from fracture
  • Infection
  • Visceral disease
  • Pregnancy
  • Major clinical depression
  • Cauda equina syndrome
  • Significant osteoporosis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Real MWM

    Sham MWM

    Arm Description

    Real mobilization with movement

    sham or placebo mobilization with movement

    Outcomes

    Primary Outcome Measures

    Flexibility
    Change of lumbar flexibility with sit and reach objective test( cm)
    Endurance
    Change of endurance of lumbar extensors with Sorensen endurance test(sn)
    Functionality with patient specific function scale
    Change of function
    Disabilities with Oswestry disability index(scale)
    Change of disabilities

    Secondary Outcome Measures

    range of motion with goniometer
    change of range of motion

    Full Information

    First Posted
    March 6, 2021
    Last Updated
    March 15, 2021
    Sponsor
    Suleyman Demirel University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04802850
    Brief Title
    Investigation of Immediate, Short and Long Term Effects of Mulligan Mobilization With Movement Techniques in Nonspesific Chronic Low Back Pain
    Official Title
    Investigation of Immediate, Short and Long Term Effects of Mulligan Mobilization With Movement Techniques in Nonspesific Chronic Low Back Pain: a Randomized Placebo-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2013 (Actual)
    Primary Completion Date
    April 1, 2014 (Actual)
    Study Completion Date
    April 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Suleyman Demirel University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Introduction: Although the effectiveness of many mobilization methods in chronic low back pain (CLBP) was shown, these effects were not monitored in the long term. The aim of this study was to identify the immediate, short and long-term effects of mulligan mobilization with movement (MWM) in terms of pain, range of motion (ROM), flexibility, endurance, functionality and disabilities in patients with CLBP. Methods: The study was designed in randomized-placebo controlled with 36 people randomly distributed into 2 groups. Sustained natural apophyseal glide (SNAG) was applied to the lumbar region, straight leg raise (SLR) with traction to the hip, and internal rotational mobilization techniques and home exercise program were applied in Group 1 (n=19); and the same techniques were applied as sham mobilization in Group 2 (n=17). The evaluations were made as post-intervention for immediate effect, and were also made at the 5th week, 3rd month, and 6th months for short and long-term effect. Evaluation was also made for pain in 12th month.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Low Back Pain

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    36 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Real MWM
    Arm Type
    Experimental
    Arm Description
    Real mobilization with movement
    Arm Title
    Sham MWM
    Arm Type
    Sham Comparator
    Arm Description
    sham or placebo mobilization with movement
    Intervention Type
    Other
    Intervention Name(s)
    Mulligan mobilization with movement
    Primary Outcome Measure Information:
    Title
    Flexibility
    Description
    Change of lumbar flexibility with sit and reach objective test( cm)
    Time Frame
    immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
    Title
    Endurance
    Description
    Change of endurance of lumbar extensors with Sorensen endurance test(sn)
    Time Frame
    immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
    Title
    Functionality with patient specific function scale
    Description
    Change of function
    Time Frame
    immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
    Title
    Disabilities with Oswestry disability index(scale)
    Description
    Change of disabilities
    Time Frame
    immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
    Secondary Outcome Measure Information:
    Title
    range of motion with goniometer
    Description
    change of range of motion
    Time Frame
    immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)-12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Having 3 months' continuous or intermittent LBP symptoms, without leg pain above the knee Pain at VAS > 3/10, Back pain increased by active lumbar flexion movement Exclusion Criteria: Confirmed nerve root compression Neurological symptoms Lumbar spine stenosis Back surgery history Chronic pain syndrome LBP from fracture Infection Visceral disease Pregnancy Major clinical depression Cauda equina syndrome Significant osteoporosis.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Investigation of Immediate, Short and Long Term Effects of Mulligan Mobilization With Movement Techniques in Nonspesific Chronic Low Back Pain

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