Pain Neuroscience Education and Physical Exercise Program in Chronic Back Pain

Fundacion para la Investigacion y Formacion en Ciencias de la Salud

Status: Unknown

Conditions: Musculoskeletal Pain; Back Pain; Chronic Pain

Treatments: Other: Usual care in Primary Care Physiotherapy Units; Other: Physical exercise; Other: Health Education

Study type: Interventional

Funder types: Other

Identifiers

NCT03654235

GRS 1396/A/16

Details and patient eligibility

About

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.

Full 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

Enrollment: 170 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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170 participants in 2 patient groups

PNE and PE program

Experimental group

Description:

Pain neuroscience education (Health education) and Physical exercise program.

Treatment:

Other: Health Education

Other: Physical exercise

Usual care in Primary Care Physiotherapy

Active Comparator group

Description:

Usual care in Primary Care Physiotherapy Units

Treatment:

Other: Usual care in Primary Care Physiotherapy Units