Chronic PainNCT03654235
Pain Neuroscience Education and Physical Exercise Program in Chronic Back Pain
A study testing Health Education and Physical exercise in people with Chronic Pain and Musculoskeletal Pain, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain, Musculoskeletal Pain, Back Pain
- What is being tested?
- Health Education and Physical exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2017to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nonspecific back pain of at least 6 months.
- Accept to participate in the study and sign the informed consent.
Who cannot join
- 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.
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- 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 locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Unidad de estrategias de Afrontamiento Activo para el dolor. Sacyl
Valladolid, 47011
Miguel Angel Galán-Martín, 983255400 ext. 88870, magalanm@saludcastillayleon.es
Federico Montero Cuadrado
About this study
Official title: Pain Neuroscience Education and Physical Exercise Program in Patients With Chronic Back Pain. Intervention From Primary Care Physiotherapy Units
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.
Read the 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
- Being tested
- Health Education, Physical exercise, Usual care in Primary Care Physiotherapy Units
- Medical subject headings
- Chronic Pain, Musculoskeletal Pain, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health EducationOther
6 pain neuroscience education sessions (10 hours) and delivery of printed reinforcement material.
Physical exerciseOther
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 UnitsOther
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
| Study group | Role | What they receive |
|---|---|---|
| PNE and PE program | Experimental | Pain neuroscience education (Health education) and Physical exercise program. Receives: Other: Health Education; Other: Physical exercise |
| Usual care in Primary Care Physiotherapy | Active comparator | Usual care in Primary Care Physiotherapy Units Receives: Other: Usual care in Primary Care Physiotherapy Units |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start1 Feb 2017
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Castilla-León Health Service, University of Valladolid
- Responsible party
- Sponsor
- Investigators
- Miguel A. Galán Martín, Principal investigator, Castilla-León Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03654235
- Sponsor's protocol ID
- GRS 1396/A/16
- Status last verified
- Feb 2020
- First submitted
- 24 Aug 2018
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31679512
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuroscience Education and Physical Exercise Program in Patients With Chronic Back Pain. Intervention From Primary Care Physiotherapy Units
- ClinicalTrials.gov ID
- NCT03654235
- Acronym / sponsor ID
- GRS 1396/A/16
- Conditions
- Chronic Pain, Musculoskeletal Pain, Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Collaborators
- Castilla-León Health Service, University of Valladolid
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNE and PE program | Experimental | Other: Health Education, Other: Physical exercisePain neuroscience education (Health education) and Physical exercise program. |
| Usual care in Primary Care Physiotherapy | Active comparator | Other: Usual care in Primary Care Physiotherapy UnitsUsual care in Primary Care Physiotherapy Units |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Nonspecific back pain of at least 6 months.
- Accept to participate in the study and sign the informed consent.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Education6 pain neuroscience education sessions (10 hours) and delivery of printed reinforcement material. | Other | PNE and PE program |
| Physical exerciseGroup 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 | PNE and PE program |
| Usual care in Primary Care Physiotherapy UnitsTreatment 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 | Other | Usual care in Primary Care Physiotherapy |
Primary outcome
Change in Health-related Quality of Life at different time points
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
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.
9 secondary outcomes
Change in Pain assessment at different time points
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Pressure pain threshold.
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
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Change in Kinesiophobia at different time points
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Change in Disability at different time points
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
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Change in Drugs consumption
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Satisfaction survey. Satisfaction with the treatment
Time frame: at 10 weeks
Modifications of body mass index.
Time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Derived from this study: PubMed 31679512Galan-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miguel A. Galán Martín principal investigator
Castilla-León Health Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Education and Physical exercise in people with Chronic Pain and Musculoskeletal Pain, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Federico Montero Cuadrado (+34 651529993, fmonteroc@saludcastillayleon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health-related Quality of Life at different time points (time frame: Change from baseline to post-treatment, to 6 months and at 12 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03654235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.