Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Randomized Placebo Controlled Trial on the Efficacy of Sustained Natural Apophyseal Glide (SNAG) in Low Back Pain Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02128607
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Benjamin Hidalgo, Université Catholique de Louvain

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.


Condition or disease Intervention/treatment Phase
Low Back Pain Manual Therapy Sustained Natural Apophyseal Glide (SNAG) Device: SNAG Device: Sham Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : February 2014
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Active Comparator: Real SNAG
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.
Device: SNAG
sustained natural apophyseal glide: SNAG / Mulligan technique

Placebo Comparator: Sham SNAG
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.
Device: Sham



Primary Outcome Measures :
  1. Kinematic spine model (Hidalgo et al 2012 Journal of rehabilitation medicine) [ Time Frame: Change from baseline until discharge of treatment (same day, single session) ]
    Use of quantitative variables for ROM and SPEED kinematic (Logit scores index)


Secondary Outcome Measures :
  1. Oswestry Disability questionnaire [ Time Frame: change from baseline until 2 weeks after treatment ]
  2. present pain with visual analog scale (VAS) [ Time Frame: change from baseline and after treatment the same day (single session) ]
  3. Tampa scale for kinesiophobia [ Time Frame: change from baseline until two weeks after treatment ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128607


Locations
Layout table for location information
Belgium
READ LAB / Tour Pasteur / Saint-Luc Hospital
Brussels, Belgium, 1200
Sponsors and Collaborators
Université Catholique de Louvain

Publications:
Layout table for additonal information
Responsible Party: Benjamin Hidalgo, PhD-s, assistant-teacher, Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT02128607     History of Changes
Other Study ID Numbers: IoNS-UCL-Hidalgo-02
First Posted: May 1, 2014    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014

Keywords provided by Benjamin Hidalgo, Université Catholique de Louvain:
low back pain
manual therapy
Mulligan
sustained natural apophyseal glide (SNAG)
Kinematic spine model

Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms