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

Immediate and Short-term Effects of Mulligan "Sustained Natural Apophyseal Glides" for a Subgroup of Low Back Pain Patients: A Randomized Placebo Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Manual Therapy; Sustained Natural Apophyseal Glide (SNAG)
• Intervention / Treatment: Device: SNAG; Device: Sham

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • READ LAB / Tour Pasteur / Saint-Luc Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Oswestry Disability questionnaire	change from baseline until 2 weeks after treatment
present pain with visual analog scale (VAS)	change from baseline and after treatment the same day (single session)
Tampa scale for kinesiophobia	change from baseline until two weeks after treatment

Collaborators and Investigators

• Sponsor: Université Catholique de Louvain

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: April 30, 2014
• First Posted (Estimate): May 1, 2014

Study Record Updates

• Last Update Posted (Estimate): August 15, 2014
• Last Update Submitted That Met QC Criteria: August 13, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Keywords: low back pain; manual therapy; Mulligan; sustained natural apophyseal glide (SNAG); Kinematic spine model
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IoNS-UCL-Hidalgo-02