Pain Neuroscience Education and Physical Exercise Program in Chronic Back Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03654235
• Other study ID #: GRS 1396/A/16
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: December 30, 2020

Study information

• Verified date: February 2020
• Source: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Contact: Federico Montero Cuadrado
• Phone: +34 651529993
• Email: fmonteroc[@]saludcastillayleon.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Musculoskeletal Pain

Intervention

Other:
• Health Education
6 pain neuroscience education sessions (10 hours) and delivery of printed reinforcement material.
• 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.
• 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

Locations

Country	Name	City	State
Spain	Unidad de estrategias de Afrontamiento Activo para el dolor. Sacyl	Valladolid

Sponsors (3)

Lead Sponsor	Collaborator
Fundacion para la Investigacion y Formacion en Ciencias de la Salud	Castilla-León Health Service, University of Valladolid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change 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.	Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Secondary	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.	Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Secondary	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.	Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Secondary	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.	Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Secondary	Change in Kinesiophobia at different time points	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.	Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Secondary	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.	Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Secondary	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.	Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Secondary	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.	Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Secondary	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.	at 10 weeks
Secondary	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.	Change from baseline to post-treatment, to 6 months and at 12 months follow-up