Additional Effect of Pain Neuroscience Education to Spinal Manipulative Therapy in Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Objectives: The primary objective will be to investigate the additional effect (immediate and
      after one-month follow up) of pain neuroscience education (PNE) to Spinal Manipulative
      Therapy (SMT) on primary outcomes of pain intensity and disability in patients with chronic
      nonspecific low back pain (CLBP).
    

Detailed description: 
      Design: This study will be a blinded randomized controlled clinical trial. Participants: One
      hundred and four participants with CLBP (18 and 55 years) both genders. Interventions:
      Individuals included will be randomized into two possible treatment arms: PNE+SMT or SMT
      alone. Each treatment will last for 8 sessions. The group submitted to PNE+SMT will received
      in the first two initial sessions an individual face-to-face PNE program of 40 minutes.Main
      outcome measures: Pain intensity and low back pain-related disability will be adopted as
      primary outcomes and as secondary outcomes we will assess fear-avoidance, pain self-efficacy
      and global perceived effect of improvement. The outcomes will be assessed on three occasions:
      pre-intervention, immediately after 8 sessions of intervention and after one-month follow-up
      period. All statistical analysis will be conducted following the principles of intention to
      treat, and the effects of treatment will be calculated using linear mixed models. Discussion:
      This study will help to better understand if PNE -a psychosocial cognitive intervention- will
      add significant effect (immediate and at follow-up) to a movement therapy protocol based on
      manual therapy.
    

Intervention name(s): Spinal Manipulative Technique; Pain Neuroscience Education
Intervention type(s): Procedure; Behavioral
Intervention description(s): 1) The application of a global low-amplitude and high-speed manipulation at the upper thoracic region between T1 and T5 levels in the dorsal decubitus position and 2) Techniques of post-anterior central mobilization applied for 30 seconds with an average of 30 repetitions in each lumbar vertebra, from L5 to L1, using grade II joint mobilization (patients positioned in the ventral decubitus position).; All participants in the PNE + SMT group will initially receive a workshop on PNE in which different concepts of pain neuroscience and pain reconceptualization will be discussed and a power-point presentation with metaphors and animated videos on the topic will be employed. The PNE program will be held in 2 sessions of 40 minutes each. The topics of the intervention program will be divided into four thematic topics according to Explain Pain concepts.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The recruited subjects will be randomized through the use of randomizer software in two groups of 52 individuals: SMT group which will receive PNE + SMT interventions or SMT alone. Both groups will be assessed at baseline (before the initial treatment session) by a blinded investigator. Immediately after the end of the last session and after the one-month follow-up, the primary outcomes and secondary outcomes will be re assessed. A single blinded investigator for the interventions administered will accomplish the assessment protocol. Another trained researcher (physiotherapist trained in SMT - 8 years of clinical experience) will administer the SMT maneuvers and a third researcher will be involved in the administration of the PNE. The treatment will last at least 8 sessions. The treatment will last at least 8 sessions lasting between 20 and 30 minutes each.
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Chronic Low Back Pain; Pain Neuroscience Education; Spinal Manipulative Techniques; Psychosocial Factors