Pain Neuroscience Education and Physical Exercise Program in Chronic Back Pain
1 other identifier
interventional
170
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable chronic-pain
Started Feb 2017
Longer than P75 for not_applicable chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 24, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedFebruary 21, 2020
February 1, 2020
3.8 years
August 24, 2018
February 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Change in Pain assessment at different time points
Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Pressure pain threshold.
Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Change in Pain Catastrophism at different time points
Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Change in Kinesiophobia at different time points
Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Change in Disability at different time points
Change from baseline to post-treatment, to 6 months and at 12 months follow-up
- +4 more secondary outcomes
Study Arms (2)
PNE and PE program
EXPERIMENTALPain neuroscience education (Health education) and Physical exercise program.
Usual care in Primary Care Physiotherapy
ACTIVE COMPARATORUsual care in Primary Care Physiotherapy Units
Interventions
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
Eligibility Criteria
You may qualify if:
- Nonspecific back pain of at least 6 months.
- Accept to participate in the study and sign the informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unidad de estrategias de Afrontamiento Activo para el dolor. Sacyl
Valladolid, 47011, Spain
Related Publications (1)
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.
PMID: 31679512DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miguel A. Galán Martín
Castilla-León Health Service
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Patients Evaluator and Outcomes Assessor are masked
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 24, 2018
First Posted
August 31, 2018
Study Start
February 1, 2017
Primary Completion
November 30, 2020
Study Completion
December 30, 2020
Last Updated
February 21, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share