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

Study Overview
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Brief Summary
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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.

Official Title
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Immediate and Short-term Effects of Mulligan Sustained Natural Apophyseal Glides for a Subgroup of Low Back Pain Patients: A Randomized Placebo Controlled Trial

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

Intervention / Treatment
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* Device: SNAG
* Device: Sham


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Real SNAG<br>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<br>* sustained natural apophyseal glide: SNAG / Mulligan technique<br>|
| Placebo Comparator: Sham SNAG<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low back pain, manual therapy, Mulligan, sustained natural apophyseal glide (SNAG), Kinematic spine model