NCT04802850

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Typical duration for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
5.9 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 17, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

March 6, 2021

Last Update Submit

March 15, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Flexibility

    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

    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

    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)

    Change of disabilities

    immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)

Secondary Outcomes (1)

  • range of motion with goniometer

    immediate(post intervention)-5 weeeks(after 5 week treatment)-3 months(after 3 months)-6 months(after 6 months)-12 months

Study Arms (2)

Real MWM

EXPERIMENTAL

Real mobilization with movement

Other: Mulligan mobilization with movement

Sham MWM

SHAM COMPARATOR

sham or placebo mobilization with movement

Other: Mulligan mobilization with movement

Interventions

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Movement

Intervention Hierarchy (Ancestors)

Physiological PhenomenaMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

March 6, 2021

First Posted

March 17, 2021

Study Start

January 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2015

Last Updated

March 17, 2021

Record last verified: 2021-03