Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03356886
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Thais Cristina Chaves, University of Sao Paulo

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).

Condition or disease Intervention/treatment Phase
Low Back Pain Procedure: Spinal Manipulative Technique Behavioral: Pain Neuroscience Education Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 104 participants
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)
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.
Primary Purpose: Treatment
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
Actual Study Start Date : November 30, 2017
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Spinal Manipulative Technique (SMT)
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
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).

Active Comparator: SMT + Pain Neuroscience Education
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
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).

Behavioral: Pain 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.




Primary Outcome Measures :
  1. Change in pain intensity after the end and at 1 month follow-up [ Time Frame: 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".

  2. Change in low back pain Disability after the end and at 1 month follow-up [ Time Frame: 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 Outcome Measures :
  1. Global Perceived Effect of treatment [ Time Frame: 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.

  2. Change in Fear Avoidance Beliefs after the end and at 1 month follow-up [ Time Frame: 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 Outcome Measures:
  1. Cognitive Performance [ Time Frame: 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.

  2. Pain catastrophizing [ Time Frame: 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.

  3. Pain Self-Efficacy Scale - PSES [ Time Frame: 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.

  4. Hospital Anxiety and Depression Scale - HADS [ Time Frame: 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.

  5. STarT Back Screening Tool (SBST) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03356886


Contacts
Layout table for location contacts
Contact: Thais C Chaves, Doctor 55 016 3602.4694 chavestc@fmrp.usp.br
Contact: Fernando AG Tavares, Specialist 55 017 98122.9897 osteopatia@allivium.com

Locations
Layout table for location information
Brazil
University of Sao Paulo Recruiting
Ribeirão Preto, São Paulo, Brazil, 14049-900
Contact: Thais C Chaves, PhD    55 016 3315 4413    chavestc@fmrp.usp.br   
Contact: Fernando AG Tavares, Doctor    55 17 98122.9897    osteopatia@allivium.com   
Sponsors and Collaborators
University of Sao Paulo
Investigators
Layout table for investigator information
Study Chair: Thais C Chaves, Doctor University São Paulo

Publications:

Layout table for additonal information
Responsible Party: Thais Cristina Chaves, Professor of the Department of Neurosciences and Behavioural Sciences of the Faculty of Medicine of Ribeirão Preto, University de São Paulo - FMRP/USP, Coordinator of the Laboratory of Research in Movement and Pain (LabMovPain), University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03356886     History of Changes
Other Study ID Numbers: 20112017
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Thais Cristina Chaves, University of Sao Paulo:
Chronic Low Back Pain
Pain Neuroscience Education
Spinal Manipulative Techniques
Psychosocial Factors

Additional relevant MeSH terms:
Layout table for MeSH terms
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms