Clinical trial NCT03654235: Pain Neuroscience Education and Physical Exercise Program in Chronic Back Pain
Official title: Pain Neuroscience Education and Physical Exercise Program in Patients With Chronic Back Pain. Intervention From Primary Care Physiotherapy Units
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Musculoskeletal Pain
Back Pain
Lead sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Sponsor class: OTHER
Collaborators: name: Castilla-León Health Service
name: University of Valladolid
First posted: 2018-08-31
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

* Nonspecific back pain of at least 6 months.
* Accept to participate in the study and sign the informed consent.

Exclusion Criteria:

* Oncological pain.
* Spine fracture or surgical intervention in last year.
* Neurological cognitive alteration that prevents understanding the contents of PNE program (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 physical exercise program.
* Patients under treatment with alternative therapies.

Primary outcomes:
measure: Change in Health-related Quality of Life at different time points
timeFrame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Secondary outcomes:
measure: Change in Pain assessment at different time points
timeFrame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
measure: Pressure pain threshold.
timeFrame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
measure: Change in Pain Catastrophism at different time points
timeFrame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
measure: Change in Kinesiophobia at different time points
timeFrame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
measure: Change in Disability at different time points
timeFrame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
measure: Change in Central sensitization levels at different time points
timeFrame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
measure: Change in Drugs consumption
timeFrame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
measure: Satisfaction survey. Satisfaction with the treatment
timeFrame: at 10 weeks
measure: Modifications of body mass index.
timeFrame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Unidad de estrategias de Afrontamiento Activo para el dolor. Sacyl
Study officials:
affiliation: Castilla-León Health Service
name: Miguel A. Galán Martín
role: PRINCIPAL_INVESTIGATOR
References:
citation: Galan-Martin MA, Montero-Cuadrado F, Lluch-Girbes E, Coca-Lopez MC, Mayo-Iscar A, Cuesta-Vargas A. Pain neuroscience education and physical exercise for patients with chronic spinal pain in primary healthcare: a randomised trial protocol. BMC Musculoskelet Disord. 2019 Nov 3;20(1):505. doi: 10.1186/s12891-019-2889-1.