Effect of Mulligan Mobilization in Chronic Non-Spesific Low Back Pain
May 2, 2020 updated by: Şule, Pamukkale University
Efficacy of Mulligan Mobilization Technique in Chronic Non-Spesific Low Back Pain
Fifty five participants diagnosed with CNSLBP, will randomized into three groups.
Group I (18 subjects) will receive 15 sessions of Conventional Physiotherapy program (CPP) 5 times per week, Group II (19 subjects) will receive 9 sessions of SNAGs, and Group III will receive CPP plus SNAGs.
Outcome measures are pain, ROM, spinal mobility, fear avoidance behaviour and function.
Measurements will record before, after and 6 month after the end of the treatment.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Inclussion criterias are; low back pain for at least 3 months, intensity of pain ranges from 3 to 6 according to VAS.
Exclussion criterias are; undergoing surgical operation in the lumbar region or having a surgical indication, having an exercise therapy and / or physical therapy in the last 1 year, a history of trauma involving lumbar region and systemic and inflammatory disease targeting this region, participants using corticosteroids for a long time and being pregnant.Acording to our criterias 55 participants diagnosed with CNSLBP will randomised into three groups.
Group 1 will receive Conventional Physiotherapy programme consisting of Hot pack, US and TENS applications.
Group II aill receive Lumbar SNAGS consisting of Lumbar Extension SNAGS in prone, SNAGS in lion position and Lumbar flexion SNAGS in sitting, techniques.
Group III will receive 9 sessions of SNAGs, and Group III will receive CPP plus SNAGs.Outcome measures are pain, ROM, spinal mobility, fear avoidance behaviour and function.
Measurements will record before, after and 6 month after the end of the treatment.
All treatment groups were treated with the same researcher.
All assessments were made by another blind researcher three times at before, after and 6 month after treatment.
Study Type
Interventional
Enrollment (Anticipated)
55
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Denizli, Turkey, 20040
- Recruiting
- Denizli State Hospital
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Contact:
- Merve Bergin Korkmaz, Dr.
- Phone Number: +905469114635
- Email: mbergina@hotmail.com
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Sub-Investigator:
- Şule Şimşek, Pdh.
-
Principal Investigator:
- Nesrin Yağcı, Prof.
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-
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
20 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- low back pain for at least 3 months
- intensity of pain ranges from 3 to 6 according to VAS
Exclusion Criteria:
- undergoing surgical operation in the lumbar region or having a surgical indication having an exercise therapy and / or physical therapy in the last 1 year
- a history of trauma involving lumbar region and systemic and inflammatory disease targeting this region
- corticosteroids consumption for a long time
- being pregnant.
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: Conventional Physiotherapy Group
Group I (18 subjects) received 15 sessions of Conventional Physiotherapy program (CPP) 5 times per week.
|
Conventional Physiotherapy consist of Hotpacks, TENS and US.The participants were positioned in prone and supported with a pillow under the abdomen, 20 min hot pack was applied.
Therapatic Ultrason were applied with the frequency of 1 MHz, intensity of 1,5 watt/cm² and duration of 5 minute.
TENS was applied to the lumbar region with 2-channel, 4 surface electrodes at 60-120 Hz, and 50-100 pulse duration for 20 minutes.
|
|
Experimental: Mulligan Mobilization Group
Mulligan Mobilization was administered 9 sessions (3 days a week, for 3 weeks). .
|
Extension SNAGS in prone, SNAGS in lion position and Lumbar flexion SNAGS in sitting, techniques were used.
The techniques were applied in 3 sets with 10 repetitions and 60 seconds rest between sets.
Other Names:
|
|
Experimental: Conventional Physiotherapy plus Mulligan Mobilization Group
Conventional Physiotherapy (15 session) plus Mulligan Mobilization Programme (9 session) were applied in this group.
CP were applied 5 days a week and CP+MM 3 days a week for 3 weeks.
|
Conventional Physiotherapy consist of Hotpacks, TENS and US.The participants were positioned in prone and supported with a pillow under the abdomen, 20 min hot pack was applied.
Therapatic Ultrason were applied with the frequency of 1 MHz, intensity of 1,5 watt/cm² and duration of 5 minute.
TENS was applied to the lumbar region with 2-channel, 4 surface electrodes at 60-120 Hz, and 50-100 pulse duration for 20 minutes.
Extension SNAGS in prone, SNAGS in lion position and Lumbar flexion SNAGS in sitting, techniques were used.
The techniques were applied in 3 sets with 10 repetitions and 60 seconds rest between sets.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change of Range of Motion from baseline at 3 weeks and from baseline at 6 months
Time Frame: Baseline, 3 weeks,6 months
|
ROM is measured by BROM II device during flexion and extension activity.
|
Baseline, 3 weeks,6 months
|
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Change of Spinal Mobility from baseline at 3 weeks and from baseline at 6 months
Time Frame: Baseline, 3 weeks,6 months
|
Spinal mobility measured by Schober test.
|
Baseline, 3 weeks,6 months
|
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Change from Pain Intensity from baseline at 3 weeks and from baseline at 6 months
Time Frame: Baseline, 3 weeks,6 months
|
Pain intensity during flexion and extension activity in lumbar region is measured by Numeric pain scale in which "0" shows No pain while "10" shows worst pain.
|
Baseline, 3 weeks,6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Fear Avoidance Behaviour from baseline at 3 weeks and from baseline at 6 months
Time Frame: Baseline, 3 weeks,6 months
|
It ıs measured by Fear Avoidance Behaviour Questionnaire-Turkish.The total score ranges from 0 to 96.
Maximum score indicates increased fear avoidanve behaviour
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Baseline, 3 weeks,6 months
|
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Change from Disability level from baseline at 3 weeks and from baseline at 6 months
Time Frame: Baseline, 3 weeks,6 months
|
It ıs measured by measured by Rolland Morris Disability Questionnaire-Turkish.Total score ranked from 0 to 24.
İncreased score represents disability in functional activities
|
Baseline, 3 weeks,6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Nesrin Yağcı, Prof. Dr., Pamukkale University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hidalgo B, Pitance L, Hall T, Detrembleur C, Nielens H. Short-term effects of Mulligan mobilization with movement on pain, disability, and kinematic spinal movements in patients with nonspecific low back pain: a randomized placebo-controlled trial. J Manipulative Physiol Ther. 2015 Jul-Aug;38(6):365-74. doi: 10.1016/j.jmpt.2015.06.013. Epub 2015 Jul 26.
- Vicenzino B, Paungmali A, Teys P. Mulligan's mobilization-with-movement, positional faults and pain relief: current concepts from a critical review of literature. Man Ther. 2007 May;12(2):98-108. doi: 10.1016/j.math.2006.07.012. Epub 2006 Sep 7.
- Hussien HM, Abdel-Raoof NA, Kattabei OM, Ahmed HH. Effect of Mulligan Concept Lumbar SNAG on Chronic Nonspecific Low Back Pain. J Chiropr Med. 2017 Jun;16(2):94-102. doi: 10.1016/j.jcm.2017.01.003. Epub 2017 Mar 30.
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)
June 14, 2017
Primary Completion (Anticipated)
June 1, 2020
Study Completion (Anticipated)
July 1, 2020
Study Registration Dates
First Submitted
February 24, 2020
First Submitted That Met QC Criteria
March 3, 2020
First Posted (Actual)
March 5, 2020
Study Record Updates
Last Update Posted (Actual)
May 5, 2020
Last Update Submitted That Met QC Criteria
May 2, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15.11.2016/20
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Because there is no web site to share my data
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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