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

NCT02128607 | Completed DMC

• 1 other identifier: IoNS-UCL-Hidalgo-02
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Manual Therapy; Sustained Natural Apophyseal Glide (SNAG)

Keywords

low back pain; manual therapy; Mulligan; sustained natural apophyseal glide (SNAG); Kinematic spine model

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (2)

Real SNAG

ACTIVE COMPARATOR

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

Sham SNAG

PLACEBO COMPARATOR

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

Interventions

SNAG DEVICE

sustained natural apophyseal glide: SNAG / Mulligan technique

Real SNAG

Sham DEVICE

Sham SNAG

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• non-specific LBP, mechanical LBP with a pain in flexion direction, the pain in flexion is reduce with the application of SNAG therapy

You may not qualify if:

• specific LBP, non-mechanical LBP, the pain is not release in a flexion direction when SNAG is appllied

Sponsors & Collaborators

• Université Catholique de Louvain: lead

Study Sites (1)

READ LAB / Tour Pasteur / Saint-Luc Hospital

Brussels, 1200, Belgium

Location

Related Publications (4)

• 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.

  PMID: 24401656 BACKGROUND

• 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.

  PMID: 23948825 BACKGROUND

• 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.

  PMID: 22847223 BACKGROUND

• 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.

  PMID: 18828921 BACKGROUND

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD-s, assistant-teacher

Study Record Dates

• First Submitted: April 29, 2014
• First Posted: May 1, 2014
• Study Start: February 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 15, 2014

Record last verified: 2014-08

Locations

BE (1)