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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
170
6 pain neuroscience education sessions (10 hours) and delivery of printed reinforcement material.
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.
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
Unidad de estrategias de Afrontamiento Activo para el dolor. Sacyl
Valladolid, Spain
RECRUITINGChange in Health-related Quality of Life at different time points
Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) V2. Spanish version. The SF-36 is a 36-item scale constructed to survey health status and quality of life. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based physical and mental health summary. Each scale is directly transformed into a 0-100 scale. Higher scores indicate better overall quality of life.
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Change in Pain assessment at different time points
Visual analog scale (VAS) scale. The VAS is a 100 mm long horizontal line ranging from '0: no pain at all' on one end to '100: worst pain imaginable' on the other end. Participants mark a point along the line that best represents the pain they are experiencing at that moment. A higher score indicates a higher level of pain.
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Pressure pain threshold.
Pressure pain threshold (PPT). A digital pressure algometer is used at four standardized points to measure the pressure pain thresholds. Higher values represent a better tolerance to pressure pain.
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Change in Pain Catastrophism at different time points
Pain catastrophizing scale (PCS). Spanish version. PCS is a short 13-item measure which evaluates the pain-related catastrophizing behaviours and cognitions of individuals. Score range from 0 - 52. A higher score indicates a higher level of catastrophism.
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Change in Kinesiophobia at different time points
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Tampa Scale of Kinesiophobia (TSK-11). Spanish version. TSK-11 is a self-report measure that contains 11 questions designed to assess a client's fear of movement and re-injury. Score range from 11 - 44. A higher score indicates a higher level of Kinesiophobia.
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Change in Disability at different time points
Roland-Morris Disability Questionnaire (RMDQ). Spanish version. It is a self-administered disability questionnaire consisting of 24 questions that are specifically related to physical functions that may be affected by back pain. Score range from 0 - 24. A higher score indicates a higher level of Disability.
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Change in Central sensitization levels at different time points
Central sensitization Inventory (CSI). Spanish version. Self-report instrument to detect the presence of central sensitization. It is a 25-item questionnaire that records the frequency of each symptom on a Likert scale from 0 (never) to 4 (always), resulting in a possible total score of 100. Higher scores are associated with higher levels of central sensitization.
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Change in Drugs consumption
Record of consumption by types of drugs. Consumption is evaluated through a survey. The results are expressed in weekly doses per drug type.
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Satisfaction survey. Satisfaction with the treatment
Client Satisfaction Questionnaire (CSQ-8). Spanish version. It is is a self-report instrument used to assess satisfaction with health services and it is used to assess participant satisfaction with the treatment. Scores range from 8 - 32. Higher scores are associated with higher satisfaction.
Time frame: at 10 weeks
Modifications of body mass index.
modification of the body mass index (BMI). Weight in Kg. and Height ill be combined to report BMI in kg/m\^2.
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up