Additional Effect of Pain Neuroscience Education to Spinal Manipulative Therapy in Chronic Low Back Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Additional Effect of Pain Neuroscience Education to Spinal Manipulative Therapy on Pain And Disability in Chronic Low Back Pain: A Randomized Clinical Trial

Conditions
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Low Back Pain

Intervention / Treatment
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* Procedure: Spinal Manipulative Technique
* Behavioral: Pain Neuroscience Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: who present chronic, non-specific, continuous and recurrent low back pain lasting at least three months and contemplate at least three of the following criteria: 1-hip internal rotation with> 35 °; 2-lumbar spine hypomobility; 3-absence of distal knee symptoms and 4-point FABQ Work score 19. Exclusion Criteria: pregnant women; red flags (neoplasia, vertebral column fracture, vertebral osteomyelitis, infection or equine tail syndrome, rheumatic diseases, diseases that compromise cognition); disc herniation; women in the luteal phase will be rescheduled; patients with cognitive deficits evaluated according to the Mini Mental State Examination with score less than or equal to 24 points or 22 points (low education level) and previous physical therapy for low back in the past year or submitted to any health/pain education strategy. Patients will be instructed to not use pain relief medications during the intervention period of this trial and if any medication be used, participants will be encouraged to report.

Ages Eligible for Study
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Minimum Age: 18 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
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Manipulative Technique (SMT)<br>This protocol of combined manipulation and mobilization techniques was adopted in view of the previous findings of a systematic review in which the combination of thrust mobilization and non-thrust techniques showed greater (moderate) evidence for chronic low back pain when compared to each technique alone (limited evidence). In addition, the thrust manipulation will be administered at the thoracic spine considering that a previous study found no differences in pain intensity after lumbar spine high-velocity manipulation versus non-region-specific manipulation in patients with chronic low back pain. | Procedure: Spinal Manipulative Technique<br>* 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).<br>|
| Active Comparator: SMT + Pain Neuroscience Education<br>Content: 1) Contextualization on the importance of the program; 2) Initial concepts on neuroscience and pain, 3) How context can influence pain perception; 5) human beings as a multisensory complex; 6) Pain and memory; 7) Nociception and nociceptors; 8) The incorrect concepts on pain; 9) Concepts on pain neurophysiology; 10) Types of sensitization; 11) Descending inhibitory system; 12) The danger message and the brain processing; 13) The sensitized brain and its relationship to chronic pain; 14) The contribution of other systems to pain experience; 15) How bone, muscles and nerves send sensory information all the time; 16) Fear avoidance model revisited; 17) Encouragement to change; 18) How to develop positive attitudes and 19) Concepts of gradual exposition and gradual activity | Procedure: Spinal Manipulative Technique<br>* 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).<br>Behavioral: Pain Neuroscience Education<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity after the end and at 1 month follow-up | The Numerical Pain Rating Scale (NPRS) used to assess pain intensity in this trial will consist in a sequence of numbers from 0 to 10, in which 0 represents no pain and 10 represents worst pain imaginable. | Baseline (before the initial treatment session), Immediately after the end of the last session and after the one-month follow-up. | 
| Change in low back pain Disability after the end and at 1 month follow-up | The Brazilian Portuguese version of Oswestry Disability Index (ODI) will be used to assess low back pain related disability. This instrument consists of 10 items, each of which has six response options. The total score will be calculated by summing up all the points, with the largest possible sum being 50. This sum will be transformed into a percentage by multiplying it by two. | Baseline (before the initial treatment session), Immediately after the end of the last session and after the one-month follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global Perceived Effect of treatment | The global perceived effect (GPE) used for this trial is an 11-point scale that ranges from -5 (vastly worse) through 0 (no change) to +5 (completely recovered) and participants are asked: Compared to when this episode first started, how would you describe your back these days?. A higher score indicates higher perception of recovery from the condition. | Immediately after the end of the last session and after the one-month follow-up. | 
| Change in Fear Avoidance Beliefs after the end and at 1 month follow-up | The fear avoidance beliefs questionnaire (FABQ) adapted for Brazilian Portuguese consists of 16 self-response items, rated on a seven-point ordinal scale from 0 (completely disagree) to 6 (completely agree). The score is obtained for each separate subscale: one that addressed the fears and beliefs of individuals in relation to work and one that addressed their fears and beliefs about physical activities. As the content of PNE included topics about fear-avoidance, the construct will be assessed. A recent systematic review showed an association between baseline fear avoidance belief and worst levels of pain and disability as treatment outcome in chronic low back pain and showed that interventions that addressed FABs were more effective than others based on biomedical concepts. | Baseline (before the initial treatment session), Immediately after the end of the last session and after the one-month follow-up. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Low Back Pain, Pain Neuroscience Education, Spinal Manipulative Techniques, Psychosocial Factors