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

Not Applicable

Completed

• Conditions: Low Back Pain; Manual Therapy; Sustained Natural Apophyseal Glide (SNAG)
• Interventions: Device: Sham; Device: SNAG

• Registration Number: NCT02128607
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-04-29
• Study First Submitted QC: 2014-04-30
• Study First Posted: 2014-05-01
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-13
• Last Update Posted: 2014-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham SNAG	Sham	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.
Real SNAG	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.

Primary Outcome Measures

Name	Time	Method
Kinematic spine model (Hidalgo et al 2012 Journal of rehabilitation medicine)	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

Name	Time	Method
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

Trial Locations

Locations (1)

READ LAB / Tour Pasteur / Saint-Luc Hospital; 🇧🇪 Brussels, Belgium