- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04802850
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
Conditions
Intervention / Treatment
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.
Sponsor
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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