A Randomized Placebo Controlled Trial on the Efficacy of Sustained Natural Apophyseal Glide (SNAG) in Low Back Pain Patients
Primary Purpose
Low Back Pain, Manual Therapy, Sustained Natural Apophyseal Glide (SNAG)
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
SNAG
Sham
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, manual therapy, Mulligan, sustained natural apophyseal glide (SNAG), Kinematic spine model
Eligibility Criteria
Inclusion Criteria:
- non-specific LBP, mechanical LBP with a pain in flexion direction, the pain in flexion is reduce with the application of SNAG therapy
Exclusion Criteria:
- specific LBP, non-mechanical LBP, the pain is not release in a flexion direction when SNAG is appllied
Sites / Locations
- READ LAB / Tour Pasteur / Saint-Luc Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Real SNAG
Sham SNAG
Arm Description
A real sustained natural apophyseal glide (SNAG / Mulligan technique) applied on the lumbar spine from a sitting position, and in a trunk flexion direction with the use of the belt.
A sham (placebo) sustained natural apophyseal glide (SNAG / Mulligan technique) applied on the lumbar spine from a sitting position, and in a trunk flexion direction with the use of the belt.
Outcomes
Primary Outcome Measures
Kinematic spine model (Hidalgo et al 2012 Journal of rehabilitation medicine)
Use of quantitative variables for ROM and SPEED kinematic (Logit scores index)
Secondary Outcome Measures
Oswestry Disability questionnaire
present pain with visual analog scale (VAS)
Tampa scale for kinesiophobia
Full Information
NCT ID
NCT02128607
First Posted
April 29, 2014
Last Updated
August 13, 2014
Sponsor
Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT02128607
Brief Title
A Randomized Placebo Controlled Trial on the Efficacy of Sustained Natural Apophyseal Glide (SNAG) in Low Back Pain Patients
Official Title
Immediate and Short-term Effects of Mulligan "Sustained Natural Apophyseal Glides" for a Subgroup of Low Back Pain Patients: A Randomized Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université Catholique de Louvain
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Objectives:
Determine the efficacy of the SNAG technique (Mulligan) applied to a subgroup of people with non-specific low back pain (LBP) on two new kinematic-algorythms, on pain, functional disability and kinesiophobia.
Design:
A randomized double blinded placebo controlled trial with double arms in accordance with the CONSORT statement.
Subjects:
Patients with non-specific low back pain will be recruting from Saint-Luc hospital, only a subgroup of them will be included according to specific inclusion criteria tailored for indication of application of SNAG's therapy (Mulligan technique applied on the lumbar spine).
Method:
Subjects will be randomized in 2 groups; real-SNAG and sham-SNAG groups. All patients will be treated during a single session, and real/sham SNAG will be applied from a sitting position with the belt, and in a flexion direction. Two kinematic-algorythms (ROM and Speed) from a validated kinematic spine model will be used and recorded with an opto-electronic device (BTS-Elite). Pain at rest and during flexion, as well as functional disability and kinesiophobia will be recorded by self-reported measures. These outcomes will be blindly evaluated before and after treatment to compare both groups with " Two-Way-ANOVA " statistic with for factors; time and groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Manual Therapy, Sustained Natural Apophyseal Glide (SNAG)
Keywords
low back pain, manual therapy, Mulligan, sustained natural apophyseal glide (SNAG), Kinematic spine model
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real SNAG
Arm Type
Active Comparator
Arm Description
A real sustained natural apophyseal glide (SNAG / Mulligan technique) applied on the lumbar spine from a sitting position, and in a trunk flexion direction with the use of the belt.
Arm Title
Sham SNAG
Arm Type
Placebo Comparator
Arm Description
A sham (placebo) sustained natural apophyseal glide (SNAG / Mulligan technique) applied on the lumbar spine from a sitting position, and in a trunk flexion direction with the use of the belt.
Intervention Type
Device
Intervention Name(s)
SNAG
Intervention Description
sustained natural apophyseal glide: SNAG / Mulligan technique
Intervention Type
Device
Intervention Name(s)
Sham
Primary Outcome Measure Information:
Title
Kinematic spine model (Hidalgo et al 2012 Journal of rehabilitation medicine)
Description
Use of quantitative variables for ROM and SPEED kinematic (Logit scores index)
Time Frame
Change from baseline until discharge of treatment (same day, single session)
Secondary Outcome Measure Information:
Title
Oswestry Disability questionnaire
Time Frame
change from baseline until 2 weeks after treatment
Title
present pain with visual analog scale (VAS)
Time Frame
change from baseline and after treatment the same day (single session)
Title
Tampa scale for kinesiophobia
Time Frame
change from baseline until two weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
non-specific LBP, mechanical LBP with a pain in flexion direction, the pain in flexion is reduce with the application of SNAG therapy
Exclusion Criteria:
specific LBP, non-mechanical LBP, the pain is not release in a flexion direction when SNAG is appllied
Facility Information:
Facility Name
READ LAB / Tour Pasteur / Saint-Luc Hospital
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
24401656
Citation
Hidalgo B, Hall T, Nielens H, Detrembleur C. Intertester agreement and validity of identifying lumbar pain provocative movement patterns using active and passive accessory movement tests. J Manipulative Physiol Ther. 2014 Feb;37(2):105-15. doi: 10.1016/j.jmpt.2013.09.006. Epub 2014 Jan 6.
Results Reference
background
PubMed Identifier
23948825
Citation
Hidalgo B, Gobert F, Bragard D, Detrembleur C. Effects of proprioceptive disruption on lumbar spine repositioning error in a trunk forward bending task. J Back Musculoskelet Rehabil. 2013;26(4):381-7. doi: 10.3233/BMR-130396.
Results Reference
background
PubMed Identifier
22847223
Citation
Hidalgo B, Gilliaux M, Poncin W, Detrembleur C. Reliability and validity of a kinematic spine model during active trunk movement in healthy subjects and patients with chronic non-specific low back pain. J Rehabil Med. 2012 Sep;44(9):756-63. doi: 10.2340/16501977-1015.
Results Reference
background
PubMed Identifier
18828921
Citation
Moutzouri M, Billis E, Strimpakos N, Kottika P, Oldham JA. The effects of the Mulligan Sustained Natural Apophyseal Glide (SNAG) mobilisation in the lumbar flexion range of asymptomatic subjects as measured by the Zebris CMS20 3-D motion analysis system. BMC Musculoskelet Disord. 2008 Oct 1;9:131. doi: 10.1186/1471-2474-9-131.
Results Reference
background
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A Randomized Placebo Controlled Trial on the Efficacy of Sustained Natural Apophyseal Glide (SNAG) in Low Back Pain Patients
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