NCT03654235

Pain Neuroscience Education and Physical Exercise Program in Chronic Back Pain

Pain Neuroscience Education and Physical Exercise Program in Patients With Chronic Back Pain. Intervention From Primary Care Physiotherapy Units

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 170 (estimated)
• Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Chronic Pain
• Musculoskeletal Pain
• Back Pain

Interventions

Type	Name	Description
OTHER	Health Education	6 pain neuroscience education sessions (10 hours) and delivery of printed reinforcement material.
OTHER	Physical exercise	Group physical exercise program (18 sessions; 3 sessions/week) leaded by a physiotherapist. It includes exercises to improve strength, coordination, balance and aerobic capacity. Work with double tasks, recreational activities to overcome kinesiophobia and activities to do at home are used in the program.
OTHER	Usual care in Primary Care Physiotherapy Units	Treatment supported by the protocol of primary care of physiotherapy in the health service of Castilla y León that was in force at the time of the intervention. Patients receive 15 sessions of analgesic electrotherapy, thermotherapy and standardized physical exercise

Timeline

• Start date: 2017-02-01
• Primary completion: 2020-11-30
• Completion: 2020-12-30
• First posted: 2018-08-31
• Last updated: 2020-02-21

Locations

1 site across 1 country: Spain