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Completed

NCT Number: NCT02128607

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

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.

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Key information

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

READ LAB / Tour Pasteur / Saint-Luc Hospital

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SNAG

Device

sustained natural apophyseal glide: SNAG / Mulligan technique

SHAM

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Université Catholique de Louvain

Other

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 1, 2014
Registry last updated
Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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