Pain Neuroscience Education and Physical Exercise Program in Chronic Back Pain

Last updated: February 19, 2020
Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Overall Status: Active - Recruiting

Phase

N/A

Condition

Chronic Pain

Pain

Acute Pain

Treatment

N/A

Clinical Study ID

NCT03654235
GRS 1396/A/16
  • Ages 18-70
  • All Genders

Study Summary

This study evaluates the effects of a pain neuroscience education (PNE) and physical exercise (PE) program in patients with chronic back pain. Half of participants receive PNE and PE program supervised by a physiotherapist and the other half receive usual physiotherapy care supported by physiotherapy protocols in primary care.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Nonspecific back pain of at least 6 months.

  • Accept to participate in the study and sign the informed consent.

Exclusion

Exclusion Criteria:

  • Oncological pain.

  • Spine fracture or surgical intervention in last year.

  • Neurological cognitive alteration that prevents understanding the contents of PNEprogram (In case of doubt, assesment with Minimental test)

  • Motor control alteration that prevents the execution of the planned PE program (Minimum requirement: execution in normal time of the Timed Up and Go test)

  • Pregnancy.

  • Bladder or bowel incontinence.

  • Saddle anesthesia.

  • Patients presenting other clinical conditions that may aggravate chronic spinal pain (chronic fatigue syndrome, fibromyalgia and complex regional pain syndrome).

  • Patients with associated pathologies that make it impossible to perform physicalexercise program.

  • Patients under treatment with alternative therapies.

Study Design

Total Participants: 170
Study Start date:
February 01, 2017
Estimated Completion Date:
December 30, 2020

Study Description

Justification: Chronic musculoskeletal pain (CMP) affects more than 20% of the population, its prevalence is increasing, generating suffering and high health expenditure. The current knowledge of neurophysiology of pain shows that the painful experience in CMP is not necessarily associated with peripheral tissue damage and is due more to an alteration of central mechanisms of pain processing and to the dysfunction of endogenous pain inhibitory mechanisms. Physical exercise (PE) has been shown to be effective in CMP. Pain neuroscience education (PNE) improves the levels of pain catastrophism, Kinesiophobia, quality of life, disability and also modifies maladaptive cognitions that favour a painful response.

Objectives: To evaluate the efficacy of a PNE and PE in patients with chronic back pain (CBP). Changes in pain intensity, pain thresholds, Catastrophism, kinesiophobia, disability, central sensitization and quality of are measured.

Material and methods: Multicenter randomized clinical trial (RCT) with 170 patients. Intervention group receive 6 sessions of PNE and a 6 weeks PE program (18 sessions) aimed at improving functional capacity, neurogenesis and cerebral plasticity. Control group receive usual physiotherapy treatment (supported by the current protocols in Primary Care in the Health System of Castilla y León). The outcome variables are measured by Visual Analog Scale (EVA), Pressure Pain Threshold (PPT), Kinesiophobia Tampa Scale (TKS-11), Central Sensitization Questionnaire (CSC), Pain Catastrophism Questionnaire (CCD), disability (Roland-Morris), Quality of life (SF-36) and satisfaction (CSQ-8). An initial assessment, post-intervention (week 10), at six months and at year is performed. Patients Evaluator and Outcomes Assessor are masked.

Applicability of results: The proposed intervention is simple and reproducible. It can be performed in the Primary Care Physiotherapy Units. It requires few resources, and it can produce changes in pain intensity, functionality and quality of life of patients with CBP

Connect with a study center

  • Unidad de estrategias de Afrontamiento Activo para el dolor. Sacyl

    Valladolid, 47011
    Spain

    Active - Recruiting

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