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

Primary Purpose

Low Back Pain

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Spinal Manipulative Technique

Pain Neuroscience Education

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Chronic Low Back Pain, Pain Neuroscience Education, Spinal Manipulative Techniques, Psychosocial Factors

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of Sao PauloRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Spinal Manipulative Technique (SMT)

SMT + Pain Neuroscience Education

Arm 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.

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

Outcomes

Primary Outcome Measures

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".

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT03356886

First Posted

November 20, 2017

Last Updated

February 27, 2019

Sponsor

University of Sao Paulo

1. Study Identification

Unique Protocol Identification Number

NCT03356886

Brief Title

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

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Unknown status

Study Start Date

November 30, 2017 (Actual)

Primary Completion Date

July 2020 (Anticipated)

Study Completion Date

July 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Sao Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Low Back Pain

Keywords

Chronic Low Back Pain, Pain Neuroscience Education, Spinal Manipulative Techniques, Psychosocial Factors

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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

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.

Allocation

Randomized

Enrollment

104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Spinal Manipulative Technique (SMT)

Arm Type

Experimental

Arm Description

Arm Title

SMT + Pain Neuroscience Education

Arm Type

Active Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Spinal Manipulative Technique

Intervention Description

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).

Intervention Type

Behavioral

Intervention Name(s)

Pain Neuroscience Education

Intervention Description

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 Measure Information:

Title

Change in pain intensity after the end and at 1 month follow-up

Description

Time Frame

Baseline (before the initial treatment session), Immediately after the end of the last session and after the one-month follow-up.

Title

Change in low back pain Disability after the end and at 1 month follow-up

Description

Time Frame

Baseline (before the initial treatment session), Immediately after the end of the last session and after the one-month follow-up.

Secondary Outcome Measure Information:

Title

Global Perceived Effect of treatment

Description

Time Frame

Immediately after the end of the last session and after the one-month follow-up.

Title

Change in Fear Avoidance Beliefs after the end and at 1 month follow-up

Description

Time Frame

Baseline (before the initial treatment session), Immediately after the end of the last session and after the one-month follow-up.

Other Pre-specified Outcome Measures:

Title

Cognitive Performance

Description

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.

Time Frame

Baseline

Title

Pain catastrophizing

Description

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.

Time Frame

Baseline

Title

Pain Self-Efficacy Scale - PSES

Description

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.

Time Frame

Baseline

Title

Hospital Anxiety and Depression Scale - HADS

Description

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.

Time Frame

Baseline

Title

STarT Back Screening Tool (SBST)

Description

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.

Time Frame

Baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Thais C Chaves, Doctor

Phone

55 016 3602.4694

chavestc@fmrp.usp.br

First Name & Middle Initial & Last Name or Official Title & Degree

Fernando AG Tavares, Specialist

Phone

55 017 98122.9897

osteopatia@allivium.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thais C Chaves, Doctor

Organizational Affiliation

University São Paulo

Official's Role

Study Chair

Facility Information:

Facility Name

University of Sao Paulo

City

Ribeirão Preto

State/Province

São Paulo

ZIP/Postal Code

14049-900

Country

Brazil

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Thais C Chaves, PhD

Phone

55 016 3315 4413

chavestc@fmrp.usp.br

First Name & Middle Initial & Last Name & Degree

Fernando AG Tavares, Doctor

Phone

55 17 98122.9897

osteopatia@allivium.com

12. IPD Sharing Statement

Citations:

PubMed Identifier

26428467

Citation

Geneen LJ, Martin DJ, Adams N, Clarke C, Dunbar M, Jones D, McNamee P, Schofield P, Smith BH. Effects of education to facilitate knowledge about chronic pain for adults: a systematic review with meta-analysis. Syst Rev. 2015 Oct 1;4:132. doi: 10.1186/s13643-015-0120-5.

Results Reference

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PubMed Identifier

21721995

Citation

Louw A, Puentedura EL, Mintken P. Use of an abbreviated neuroscience education approach in the treatment of chronic low back pain: a case report. Physiother Theory Pract. 2012 Jan;28(1):50-62. doi: 10.3109/09593985.2011.562602. Epub 2011 Jul 3.

Results Reference

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PubMed Identifier

22688603

Citation

Gallagher L, McAuley J, Moseley GL. A randomized-controlled trial of using a book of metaphors to reconceptualize pain and decrease catastrophizing in people with chronic pain. Clin J Pain. 2013 Jan;29(1):20-5. doi: 10.1097/AJP.0b013e3182465cf7.

Results Reference

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PubMed Identifier

27351541

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.

Results Reference

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PubMed Identifier

25426289

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.

Results Reference

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PubMed Identifier

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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.

Results Reference

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PubMed Identifier

21705261

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.

Results Reference

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

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