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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02128607
• Other study ID #: IoNS-UCL-Hidalgo-02
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: August 13, 2014
• Start date: February 2014
• Est. completion date: July 2014

Study information

• Verified date: August 2014
• Source: Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• SNAG
sustained natural apophyseal glide: SNAG / Mulligan technique
• Sham

Locations

Country	Name	City	State
Belgium	READ LAB / Tour Pasteur / Saint-Luc Hospital	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Oswestry Disability questionnaire		change from baseline until 2 weeks after treatment	No
Secondary	present pain with visual analog scale (VAS)		change from baseline and after treatment the same day (single session)	No
Secondary	Tampa scale for kinesiophobia		change from baseline until two weeks after treatment	No