A Randomized Placebo Controlled Trial on the Efficacy of Sustained Natural Apophyseal Glide (SNAG) in Low Back Pain Patients
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|ClinicalTrials.gov Identifier: NCT02128607|
Recruitment Status : Completed
First Posted : May 1, 2014
Last Update Posted : August 15, 2014
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.
A randomized double blinded placebo controlled trial with double arms in accordance with the CONSORT statement.
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).
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|
|Low Back Pain Manual Therapy Sustained Natural Apophyseal Glide (SNAG)||Device: SNAG Device: Sham||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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 :||February 2014|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
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.
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.
- 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)
- Oswestry Disability questionnaire [ Time Frame: change from baseline until 2 weeks after treatment ]
- present pain with visual analog scale (VAS) [ Time Frame: change from baseline and after treatment the same day (single session) ]
- Tampa scale for kinesiophobia [ Time Frame: change from baseline until two weeks after treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02128607
|READ LAB / Tour Pasteur / Saint-Luc Hospital|
|Brussels, Belgium, 1200|