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

March 15, 2021 updated by: HATİCE YAKUT, Suleyman Demirel University

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

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Real MWM
Real mobilization with movement
Sham Comparator: Sham MWM
sham or placebo mobilization with movement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flexibility
Time Frame: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
Change of lumbar flexibility with sit and reach objective test( cm)
immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
Endurance
Time Frame: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
Change of endurance of lumbar extensors with Sorensen endurance test(sn)
immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
Functionality with patient specific function scale
Time Frame: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
Change of function
immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
Disabilities with Oswestry disability index(scale)
Time Frame: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)
Change of disabilities
immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
range of motion with goniometer
Time Frame: immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)-12 months
change of range of motion
immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)-12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2013

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

March 6, 2021

First Submitted That Met QC Criteria

March 15, 2021

First Posted (Actual)

March 17, 2021

Study Record Updates

Last Update Posted (Actual)

March 17, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • study1984

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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