Low Back Pain
Conditions
Keywords
Chronic Low Back Pain, Pain Neuroscience Education, Spinal Manipulative Techniques, Psychosocial Factors
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.
Interventions
PROCEDURESpinal Manipulative Technique
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).
BEHAVIORALPain Neuroscience Education
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.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Once the patient has accepted the invitation to participate, the same researcher (FAGT) will gather the clinical assessment and determine eligibility. After this initial assessment, participants will be randomly assigned following simple computerized randomisation procedures to one of the two treatment groups through the use of cards previously placed in opaque sealed envelopes. The allocation sequence will be generated by a researcher (TCC) not involved in the assessment and interventions, and another research assistant will assign participants to interventions.
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain intensity after the end and at 1 month follow-up | Baseline (before the initial treatment session), Immediately after the end of the last session and after the one-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. |
| Change in low back pain Disability after the end and at 1 month follow-up | Baseline (before the initial treatment session), Immediately after the end of the last session and after the one-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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Global Perceived Effect of treatment | Immediately after the end of the last session and after the one-month follow-up. | 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. |
| Change in Fear Avoidance Beliefs after the end and at 1 month follow-up | Baseline (before the initial treatment session), Immediately after the end of the last session and after the one-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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Cognitive Performance | Baseline | The MMSE is a tool that can be used to systematically and thoroughly assess mental status. We used the Brazilian-Portuguese version of the tool. It is an 11-question measure that tests 5 areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The maximum score is 30. A score of ≤22 is indicative of cognitive impairment. The Mini-Mental State Examination (MMSE) was used to exclude cognitive impairment. |
| STarT Back Screening Tool (SBST) | Baseline | The SBST questionnaire was translated to Brazilian Portuguese and its psychometric measurements were checked. The questionnaire is comprised of 9 items. For the purposes of scoring and classification, respondents were given answer options of I agree and I disagree for the first 8 items, which were scored 1 and 0 points, respectively. For total scores greater than 3, classification was based on the psychosocial subscale score (items 5 to 9) as follows: scores ≤3 corresponded to medium risk and scores \>3 corresponded to high risk. |
| Pain catastrophizing | Baseline | The Pain Catastrophizing Scale (PCS) translated and validated to Brazilian Portuguese will be used. The scale is composed of 13 items staggered on 6-point ordinal scale (0-5). The total score is the sum of the items divided by the number of items answered, with the minimum score being 0 and the maximum being 5 for each item. Higher scores indicated a greater presence of catastrophic thoughts. The total score of the scale could vary between 0 and 52 points. A recent systematic review found that catastrophizing to be associated with pain and disability at follow-up in CLBP patients. |
| Pain Self-Efficacy Scale - PSES | Baseline | Study participants will be evaluated on self-efficacy related to chronic pain, which can be defined as an individual's confidence he/she can successfully produce desirable results related to living with chronic pain. The Pain Self-Efficacy Scale (PSES) has 10 items which are rated on a 7-point ordinal scale (ranging from 0: not at all confident to 6: completely confident). It was adapted and validated to Brazilian Portuguese. Previous research showed an effect on self-efficacy using a PNE intervention based on metaphors compared to an intervention using cognitive-behavioral concepts. |
| Hospital Anxiety and Depression Scale - HADS | Baseline | The HADS will be employed to identify anxiety disorders and depression. It was translated and validated into Portuguese. The HADS is divided into the anxiety subscale (HADS-A) and the depression subscale (HADS-D), both containing seven interspersed items. It is composed of seven items for depression and seven items for anxiety, each item including four response options ranging from 0 to 3. A cutoff of ≥8 was described with good sensitivity and specificity values (0.70-0.90) for anxiety and depression symptoms. |
Countries
Brazil
Outcome results
None listed