Clinical trial NCT03356886: Additional Effect of Pain Neuroscience Education to Spinal Manipulative Therapy in Chronic Low Back Pain
Official title: Additional Effect of Pain Neuroscience Education to Spinal Manipulative Therapy on Pain And Disability in Chronic Low Back Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Chronic Low Back Pain
Pain Neuroscience Education
Spinal Manipulative Techniques
Psychosocial Factors
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. who present chronic, non-specific, continuous and recurrent low back pain lasting at least three months and
2. 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:

1. pregnant women;
2. red flags (neoplasia, vertebral column fracture, vertebral osteomyelitis, infection or equine tail syndrome, rheumatic diseases, diseases that compromise cognition);
3. disc herniation;
4. women in the luteal phase will be rescheduled;
5. 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
6. 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.

Primary outcomes:
measure: Change in pain intensity after the end and at 1 month follow-up
timeFrame: Baseline (before the initial treatment session), Immediately after the end of the last session and after the one-month follow-up.
measure: Change in low back pain Disability after the end and at 1 month follow-up
timeFrame: Baseline (before the initial treatment session), Immediately after the end of the last session and after the one-month follow-up.
Secondary outcomes:
measure: Global Perceived Effect of treatment
timeFrame: Immediately after the end of the last session and after the one-month follow-up.
measure: Change in Fear Avoidance Beliefs after the end and at 1 month follow-up
timeFrame: Baseline (before the initial treatment session), Immediately after the end of the last session and after the one-month follow-up.
Other outcomes:
measure: Cognitive Performance
timeFrame: Baseline
measure: Pain catastrophizing
timeFrame: Baseline
measure: Pain Self-Efficacy Scale - PSES
timeFrame: Baseline
measure: Hospital Anxiety and Depression Scale - HADS
timeFrame: Baseline
measure: STarT Back Screening Tool (SBST)
timeFrame: Baseline
Locations:
city: Ribeirão Preto
country: Brazil
facility: University of Sao Paulo
state: São Paulo
Study officials:
affiliation: University São Paulo
name: Thais C Chaves, Doctor
role: STUDY_CHAIR
References:
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citation: Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
citation: Dougherty PE, Karuza J, Savino D, Katz P. Evaluation of a modified clinical prediction rule for use with spinal manipulative therapy in patients with chronic low back pain: a randomized clinical trial. Chiropr Man Therap. 2014 Nov 18;22(1):41. doi: 10.1186/s12998-014-0041-8. eCollection 2014.
citation: Hidalgo B, Detrembleur C, Hall T, Mahaudens P, Nielens H. The efficacy of manual therapy and exercise for different stages of non-specific low back pain: an update of systematic reviews. J Man Manip Ther. 2014 May;22(2):59-74. doi: 10.1179/2042618613Y.0000000041.
citation: Clarke CL, Ryan CG, Martin DJ. Pain neurophysiology education for the management of individuals with chronic low back pain: systematic review and meta-analysis. Man Ther. 2011 Dec;16(6):544-9. doi: 10.1016/j.math.2011.05.003. Epub 2011 Jun 25.