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

University of Sao Paulo

Status: Completed

Conditions: Low Back Pain

Treatments: Procedure: Spinal Manipulative Technique; Behavioral: Pain Neuroscience Education

Study type: Interventional

Funder types: Other

Identifiers

NCT03356886

20112017

Details and patient eligibility

About

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).

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

104 participants in 2 patient groups

Spinal Manipulative Technique (SMT)

Experimental group

Description:

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.

Treatment:

Procedure: Spinal Manipulative Technique

SMT + Pain Neuroscience Education

Active Comparator group

Description:

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

Treatment:

Procedure: Spinal Manipulative Technique

Behavioral: Pain Neuroscience Education