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Effect of Mulligan Mobilization in Chronic Non-Spesific Low Back Pain

Primary Purpose

Chronic Pain

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Conventional Physiotherapy
Mulligan Mobilization
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Lumbal SNAGs, efficiency

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Denizli State HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Conventional Physiotherapy Group

Mulligan Mobilization Group

Conventional Physiotherapy plus Mulligan Mobilization Group

Arm Description

Group I (18 subjects) received 15 sessions of Conventional Physiotherapy program (CPP) 5 times per week.

Mulligan Mobilization was administered 9 sessions (3 days a week, for 3 weeks). .

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.

Outcomes

Primary Outcome Measures

Change of Range of Motion from baseline at 3 weeks and from baseline at 6 months
ROM is measured by BROM II device during flexion and extension activity.
Change of Spinal Mobility from baseline at 3 weeks and from baseline at 6 months
Spinal mobility measured by Schober test.
Change from Pain Intensity from baseline at 3 weeks and from baseline at 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.

Secondary Outcome Measures

Change from Fear Avoidance Behaviour from baseline at 3 weeks and from baseline at 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
Change from Disability level from baseline at 3 weeks and from baseline at 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

Full Information

First Posted
February 24, 2020
Last Updated
May 2, 2020
Sponsor
Pamukkale University
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1. Study Identification

Unique Protocol Identification Number
NCT04297527
Brief Title
Effect of Mulligan Mobilization in Chronic Non-Spesific Low Back Pain
Official Title
Efficacy of Mulligan Mobilization Technique in Chronic Non-Spesific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 14, 2017 (Actual)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Lumbal SNAGs, efficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
All assessments were made by another blind researcher three times at before, after and 6 month after treatment.
Allocation
Randomized
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Physiotherapy Group
Arm Type
Experimental
Arm Description
Group I (18 subjects) received 15 sessions of Conventional Physiotherapy program (CPP) 5 times per week.
Arm Title
Mulligan Mobilization Group
Arm Type
Experimental
Arm Description
Mulligan Mobilization was administered 9 sessions (3 days a week, for 3 weeks). .
Arm Title
Conventional Physiotherapy plus Mulligan Mobilization Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional Physiotherapy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Mulligan Mobilization
Other Intervention Name(s)
Lumbal SNAGs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Range of Motion from baseline at 3 weeks and from baseline at 6 months
Description
ROM is measured by BROM II device during flexion and extension activity.
Time Frame
Baseline, 3 weeks,6 months
Title
Change of Spinal Mobility from baseline at 3 weeks and from baseline at 6 months
Description
Spinal mobility measured by Schober test.
Time Frame
Baseline, 3 weeks,6 months
Title
Change from Pain Intensity from baseline at 3 weeks and from baseline at 6 months
Description
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.
Time Frame
Baseline, 3 weeks,6 months
Secondary Outcome Measure Information:
Title
Change from Fear Avoidance Behaviour from baseline at 3 weeks and from baseline at 6 months
Description
It ıs measured by Fear Avoidance Behaviour Questionnaire-Turkish.The total score ranges from 0 to 96. Maximum score indicates increased fear avoidanve behaviour
Time Frame
Baseline, 3 weeks,6 months
Title
Change from Disability level from baseline at 3 weeks and from baseline at 6 months
Description
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
Time Frame
Baseline, 3 weeks,6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Şule ŞİMŞEK, Dr.
Phone
+9005058099914
Email
suleserefsimsek@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Merve Bergin Korkmaz, Dr.
Phone
+905469114635
Email
mbergina@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nesrin Yağcı, Prof. Dr.
Organizational Affiliation
Pamukkale University
Official's Role
Study Director
Facility Information:
Facility Name
Denizli State Hospital
City
Denizli
ZIP/Postal Code
20040
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merve Bergin Korkmaz, Dr.
Phone
+905469114635
Email
mbergina@hotmail.com
First Name & Middle Initial & Last Name & Degree
Şule Şimşek, Pdh.
First Name & Middle Initial & Last Name & Degree
Nesrin Yağcı, Prof.

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Because there is no web site to share my data
Citations:
PubMed Identifier
26215900
Citation
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.
Results Reference
background
PubMed Identifier
16959529
Citation
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.
Results Reference
background
PubMed Identifier
28559749
Citation
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.
Results Reference
background

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Effect of Mulligan Mobilization in Chronic Non-Spesific Low Back Pain

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