MedDataX Logo

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

NCT ID: NCT03356886

Last Updated: 2023-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-30

Study Completion Date

2020-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Spinal Manipulative Technique

Intervention Type PROCEDURE

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).

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

Group Type ACTIVE_COMPARATOR

Spinal Manipulative Technique

Intervention Type PROCEDURE

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).

Pain Neuroscience Education

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type PROCEDURE

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

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)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thais C Chaves, Doctor

Role: STUDY_CHAIR

University São Paulo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Sao Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 26428467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21721995 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22688603 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27351541 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25426289 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24976749 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21705261 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

20112017

Identifier Type: -

Identifier Source: org_study_id