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

Sponsor
Université Catholique de Louvain (Other)
Overall Status
Completed
CT.gov ID
NCT02128607
Collaborator
(none)
32
1
2
4.9
6.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: SNAG
  • Device: Sham
N/A

Study Design

Study Type:
Interventional
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 :
Feb 1, 2014
Actual Primary Completion Date :
Jul 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Oswestry Disability questionnaire [change from baseline until 2 weeks after treatment]

  2. present pain with visual analog scale (VAS) [change from baseline and after treatment the same day (single session)]

  3. Tampa scale for kinesiophobia [change from baseline until two weeks after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 READ LAB / Tour Pasteur / Saint-Luc Hospital Brussels Belgium 1200

Sponsors and Collaborators

  • Université Catholique de Louvain

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Benjamin Hidalgo, PhD-s, assistant-teacher, Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT02128607
Other Study ID Numbers:
  • IoNS-UCL-Hidalgo-02
First Posted:
May 1, 2014
Last Update Posted:
Aug 15, 2014
Last Verified:
Aug 1, 2014
Keywords provided by Benjamin Hidalgo, PhD-s, assistant-teacher, Université Catholique de Louvain
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2014