Chronic Pain (Back / Neck)AP-AADCNCT07133607
Effectiveness of a Pain Neuroscience Education and Therapeutic Exercise Program Delivered by Primary Care Physiotherapists to Patients With Chronic Nociplastic Spinal Pain
A study testing education about pain and physical excersice, education about pain and physical excersice with somatosensorial treatment and Classic physiotherapy treatment with physical exercise, analgesic electrotherapy and thermotherapy in people with Chronic Pain (Back / Neck), run by Distrito de Atención Primaria Sevilla.
Trial summary
The main objective of the project is to evaluate the effectiveness, in terms of quality of life, of a therapy based on an Active Coping Protocol for Non-Cancer Chronic Pain in the Primary Care setting. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain (Back / Neck)
- What is being tested?
- education about pain and physical excersice, education about pain and physical excersice with somatosensorial treatment and Classic physiotherapy treatment with physical exercise, analgesic electrotherapy and thermotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Users of the Public Health System of Andalusia, registered in the User Database (BDU) of the Sevilla Health District.
- Ages between 18 and 70.
- Chronic lumbar pain lasting more than 3 months, likely due to central sensitization (likely nociplastic pain).
- The diagnosis of Central Sensitization will be made according to the most recent algorithm published by Nijs et al. in Lancet.
Who cannot join
- Oncological pain (pain related to cancer)
- Spinal fracture or spinal surgery in the previous year.
- Neurological cognitive impairment that prevents understanding of pain neuroeducation (if in doubt, the Minimental Test will be performed, requiring a minimum score of 25)
- Physical conditioning deficit that prevents the execution of the Physical --Education program (minimum requirement: normal execution time of <10 seconds for the timed "Up and Go" test).
- Pregnancy
- Cauda equina syndrome
Show all 13Show fewer
- Chronic fatigue syndrome
- Fibromyalgia
- Complex Regional Pain Syndrome
- Clinical conditions that may aggravate chronic spinal pain.
- Associated pathologies that prevent the performance of a physical exercise program (myopathies and neurological disorders).
- Currently undergoing alternative therapies.
- The presence of pain in other anatomical regions, apart from spinal pain, is not a reason for exclusion.
About this study
Official title: Effectiveness of a Pain Neuroscience Education and Therapeutic Exercise Program Delivered by Primary Care Physiotherapists to Patients With Chronic Nociplastic Spinal Pain: a Multicenter Randomized Controlled Trial.
The main objective of the project is to evaluate the effectiveness, in terms of quality of life, of a therapy based on an Active Coping Protocol for Non-Cancer Chronic Pain in the Primary Care setting. This approach involves no medications or invasive procedures and is based on pain neuroscience education and physical exercise, either alone or combined with treatment targeting body schema and somatosensory disturbances. The comparison will be made against a treatment involving thermotherapy and traditional physical exercise.
One of the most well-documented national primary care experiences combining pain neuroeducation and physical exercise, with a detailed methodology, was carried out by the Health System of Castilla y León (Sacyl) in Valladolid. It yielded significant results using a protocol consisting of 6 sessions of pain neuroscience education and 18 sessions of group exercise.
Read more
Based on this reference study, two hypotheses are proposed: the first is that reducing the number of sessions in the Active Coping Protocol for Chronic Pain would maintain treatment effectiveness. The second hypothesis suggests the potential for improved outcomes by combining the Active Coping Protocol with body schema and somatosensory disturbance treatment.
To test these hypotheses, a randomized experimental study with three parallel groups will be conducted on patients aged 18 to 70, referred to Physiotherapy from health centers in the Sevilla Health District. These patients experience daily spinal chronic pain for more than 3 months or on at least half of the days over more than 6 months, with central sensitization as the underlying cause.
Effectiveness will be measured in terms of quality of life (SF-36), pain intensity (Visual Analog Scale), satisfaction level, kinesiophobia, catastrophizing, pressure pain threshold, disability index (NDI/Oswestry), medication reduction, and number of monthly medical appointments.
Secondary objectives include evaluating, in both experimental groups compared to the control, the outcome variables: pain intensity, treatment adherence, kinesiophobia, catastrophizing, pressure pain threshold, descending modulation system, lumbar disability index, severity level, anxiety, sleep quality, analgesic consumption, healthcare visits, and satisfaction with care received.
A sample size of 135 patients has been calculated and will be randomized into the three study groups. The control group will receive thermotherapy-electrotherapy and conventional therapeutic exercise. Experimental group 1 will follow the Active Coping Program for Chronic Pain (4 education sessions and 12 physical exercise sessions). Experimental group 2 will receive somatosensory and body schema treatment along with the Active Coping Program.
The study is evaluator-blinded. Statistical analysis will be performed using SPSS version 28 and R Core Team (2023). Statistical significance will be set at p-values <0.05. Authorization will be requested from the relevant Research Ethics Committee.
The results of this study may lead to updates of existing protocols, development of guidelines and manuals for managing chronic musculoskeletal pain, ongoing training for primary care professionals, and publication in high-impact scientific journals to disseminate knowledge.
- Conditions
- Chronic Pain (Back / Neck)
- Being tested
- education about pain and physical excersice, education about pain and physical excersice with somatosensorial treatment, Classic physiotherapy treatment with physical exercise, analgesic electrotherapy and thermotherapy
- Keywords
- pain chronic, central sensibilitation, public health system, pain education, physiotherapy, somatosensory, body outline, therapeutic physical exercise
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education about pain and physical excersiceOther
The sessions will be conducted in groups of 10 to 15 patients.
- 4 pain science education sessions, each lasting 1.5 hours (6 hours), with one session per week, for 4 weeks.
- 12 therapeutic physical exercise program sessions, each lasting 1 hour, to be conducted over 6 weeks (12 hours), with two sessions per week. Although the intervention is group-based, individual instructions will be given to patients. Reference will be made to the content learned in the neuroeducation sessions. The exercise dose must be adjusted to the patient's condition, keeping in mind that, due to the inhibition of the descending pain modulation system, they may experience an initial increase in pain during the first sessions, so as not to alarm the patient and prevent the activity from being discontinued. The main objective is to increase the patient's functionality, an aspect that will be constantly reinforced.
The session structure will be as recommended by the American College of Sports Medicine, with se
education about pain and physical excersice with somatosensorial treatmentOther
Patients assigned to this group will receive, in addition to the same intervention as the AADC study group "intervention type 2" (education about pain), somatosensory and body schema treatment for the changes observed in an initial assessment during the 4 weeks prior.
The prescribed treatment will be repeated daily at home. To facilitate
the progress of the treatment, it is recommended that a companion participate in the first session, when possible, where the daily intervention to be performed at home will be explained.
If the participation of a companion is not possible, the patient will attend the Health Center's physiotherapy room once a day to be accompanied by the physiotherapist and offered the same treatment opportunities.
As a control and monitoring measure, the patient will attend the physiotherapy room once a week and will be called again weekly to verify that the treatment is being performed correctly. They will also be provided with a form to record their home treatment.
Classic physiotherapy treatment with physical exercise, analgesic electrotherapy and thermotherapyOther
The patients will receive the usual physiotherapy treatment provided in Primary Care Physiotherapy units, supported by the current Primary Care Physiotherapy protocols of Castilla y León, since Andalusia does not currently have any published. The patient will receive 12 sessions of thermotherapy (Infrared/Microwave) and analgesic electrotherapy (analgesic Tens currents) in the painful area(s), and will be prescribed exercises recommended by the Spanish Society of Physical Medicine and Rehabilitation (SERMEF). The learning and execution of the exercises will be supervised by a Primary Care physiotherapist. The sessions will be with a frequency of 2 per week on alternate days for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | The patients will receive the usual physiotherapy treatment provided in Primary Care Physiotherapy units, supported by the current Primary Care Physiotherapy protocols of Castilla y León (33), since Andalusia does not currently have any published. The patient will receive 12 sessions of thermotherapy (Infrared/Microwave) and analgesic electrotherapy (analgesic Tens currents) in the painful area(s), and will be prescribed exercises recommended by the Spanish Society of Physical Medicine and Rehabilitation (SERMEF) (34). The learning and execution of the exercises will be supervised by a Primary Care physiotherapist. The sessions will be with a frequency of 2 per week on alternate days for 6 weeks. Receives: Other: Classic physiotherapy treatment with physical exercise, analgesic electrotherapy and thermotherapy |
| intervention type 1, education to pain and physical exercise | Experimental | The sessions will be conducted in groups of 10 to 15 patients.
* 4 pain science education sessions, each lasting 1.5 hours (6 hours), with one session per week, for 4 weeks.
* 12 therapeutic physical exercise program sessions, each lasting 1 hour, to be conducted over 6 weeks (12 hours), with two sessions per week. Although the intervention is group-based, individual instructions will be given to patients. Reference will be made to the content learned in the neuroeducation sessions. The exercise dose must be adjusted to the patient's condition, keeping in mind that, due to the inhibition of the descending pain modulation system, they may experience an initial increase in pain during the first sessions, so as not to alarm the patient and prevent the activity from being discontinued. The main objective is to increase the patient's functionality, an aspect that will be constantly reinforced.
The session structure will be as recommended by the American College of Sports Medicine, with se Receives: Other: education about pain and physical excersice |
| intervention type 2, education to pain and physical exercise with somatosensorial treatment | Experimental | Patients assigned to this group will receive, in addition to the same intervention as the AADC study group "intervention type 2", somatosensory and body schema treatment for the changes observed in an initial assessment during the 4 weeks prior.
The prescribed treatment will be repeated daily at home. To facilitate
the progress of the treatment, it is recommended that a companion participate in the first session, when possible, where the daily intervention to be performed at home will be explained.
If the participation of a companion is not possible, the patient will attend the Health Center's physiotherapy room once a day to be accompanied by the physiotherapist and offered the same treatment opportunities.
As a control and monitoring measure, the patient will attend the physiotherapy room once a week and will be called again weekly to verify that the treatment is being performed correctly. They will also be provided with a form to record their home treatment. Receives: Other: education about pain and physical excersice with somatosensorial treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the value of quality of life measured Trough sf 36 questionnaire at 6 Months
0 equals very poor quality of life and 100 very good quality of life
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Secondary outcomes (16)
Change from Baseline in the value of pain intensitivity measured trough AVS scale at 6 Months
0 equals absence of pain and 10 a lot of pain
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of regular physical activity measured Trough international physical activity questionnaire (IPAQ)at 6 Months
low/moderate/high
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of kinesophobia measured Trough kinesophobia questionnaireTampa-TSK-11SV at 6 Months
The lowest possible score, 11, denotes negligible or nonexistent kinesiophobia. The highest possible score, 44, denotes a severe fear of experiencing pain when moving.
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of Pain Catastrophizing measured Trough Pain Catastrophizing Scale (PCS) at 6 Months
Together with three subscale scores assessing rumination, magnification, and helplessness, the overall score has a range of 0-52.
Higher scores indicate a greater degree of pain catastrophizing. A total score >30 represents a clinically significant level of pain catastrophizing.
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of pain threshold to pressure at 6 Months trough the protocol described in the study by Neziri et al, measuring four points using the procedure described by Fisher
A pain threshold below 4 kg/cm2 identifies increased sensitivity to pressure.
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of Conditional pain modulation system at 6 Months trough Protocol validated by Larsen et al.
The UDP is assessed in the anterior tibial muscle (three times to calculate the mean), then, using a conditioning clamp, a tonic pain stimulus is applied by pinching the earlobe for 60 seconds (10). When the VAS of earlobe pain exceeds 60 mm, the pressure pain threshold in the anterior tibial muscle is assessed again three times. The CPM effect is calculated as the percentage change [(conditioning/baseline × 100) - 100] and the difference [conditioning-baseline] in the pressure pain threshold as recommended by Yamitsky D. et al.
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of lumbar disability index measured Trough Rolland Morris Scale at 6 Months
The final score, out of 24 represents the degree of disability due to low back pain. A maximum score of 24 indicates the greatest degree of disability from back pain.
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of Level of severity of the case at 6 Months trough the Central Sensitization Inventory
0 equals absence of severity associated with central sensitization and 100 a lot of severity associated
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of sleep quality and patterns in adults of the case at 6 Months trough The Pittsburgh Sleep Quality Questionnaire (PSQI)
It provides a global measure of sleep quality, with a range of 0 to 21, where scores greater than 5 suggest significant alterations in sleep quality
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of Medication intake of the case at 6 Months trough a survey
The results will be expressed in weekly doses according to the type of drug taken.
Measured: from the start of treatment, at 11 weeks and at 26 weeks
During the follow-up period, visits to the family doctor, emergency services, and specialists will be recorded using the Digital Health Record.
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of satisfaction with health services of the case at 6 Months trough The Spanish version of the Client Satisfaction Questionnaire (CSQ-8)
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of Regular physical activity of the case at 6 Months trough International Physical Activity Questionnaire (IPAQ).
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of fatigue intensitivity measured trough AVS scale at 6 Months
0 equals absence of fatigue and 10 a lot of fatigue
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of short stress test at 6 Months trough number of squats in 30 seconds, 60 seconds, and modified Borg scale of perceived exertion
0 equals absence of perceived exertion and 10 a lot of perceived exertion
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of Flamingo Balance Test at 6 Months trough number of times you need to land in 30"
Measured: from the start of treatment, at 11 weeks and at 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (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 Pain (Back / Neck)Studies 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
- Model description
- parallel study for three interventions groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Distrito de Atención Primaria Sevilla
- Sponsor type
- University, hospital or other
- Collaborators
- Junta de Andalucia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133607
- Sponsor's protocol ID
- FISIOTERAPIA3
- Other IDs
- AP-AADC
- Acronym
- AP-AADC
- Status last verified
- Jun 2025
- First submitted
- 22 Jul 2025
- Last updated
- 11 Sep 2025
- 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 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Pain Neuroscience Education and Therapeutic Exercise Program Delivered by Primary Care Physiotherapists to Patients With Chronic Nociplastic Spinal Pain: a Multicenter Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT07133607
- Acronym / sponsor ID
- AP-AADC / FISIOTERAPIA3
- Conditions
- Chronic Pain (Back / Neck)
- Keywords
- pain chronic, central sensibilitation, public health system, pain education, physiotherapy, somatosensory, body outline, therapeutic physical exercise
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Distrito de Atención Primaria SevillaUniversity, hospital or other
- Collaborators
- Junta de Andalucia
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Aug 2025 (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.
The main objective of the project is to evaluate the effectiveness, in terms of quality of life, of a therapy based on an Active Coping Protocol for Non-Cancer Chronic Pain in the Primary Care setting. This approach involves no medications or invasive procedures and is based on pain neuroscience education and physical exercise, either alone or combined with treatment targeting body schema and somatosensory disturbances. The comparison will be made against a treatment involving thermotherapy and traditional physical exercise.
One of the most well-documented national primary care experiences combining pain neuroeducation and physical exercise, with a detailed methodology, was carried out by the Health System of Castilla y León (Sacyl) in Valladolid. It yielded significant results using a protocol consisting of 6 sessions of pain neuroscience education and 18 sessions of group exercise.
Based on this reference study, two hypotheses are proposed: the first is that reducing the number of sessions in the Active Coping Protocol for Chronic Pain would maintain treatment effectiveness. The second hypothesis suggests the potential for improved outcomes by combining the Active Coping Protocol with body schema and somatosensory disturbance treatment.
To test these hypotheses, a randomized experimental study with three parallel groups will be conducted on patients aged 18 to 70, referred to Physiotherapy from health centers in the Sevilla Health District. These patients experience daily spinal chronic pain for more than 3 months or on at least half of the days over more than 6 months, with central sensitization as the underlying cause.
Effectiveness will be measured in terms of quality of life (SF-36), pain intensity (Visual Analog Scale), satisfaction level, kinesiophobia, catastrophizing, pressure pain threshold, disability index (NDI/Oswestry), medication reduction, and number of monthly medical appointments.
Secondary objectives include evaluating, in both experimental groups compared to the control, the outcome variables: pain intensity, treatment adherence, kinesiophobia, catastrophizing, pressure pain threshold, descending modulation system, lumbar disability index, severity level, anxiety, sleep quality, analgesic consumption, healthcare visits, and satisfaction with care received.
A sample size of 135 patients has been calculated and will be randomized into the three study groups. The control group will receive thermotherapy-electrotherapy and conventional therapeutic exercise. Experimental group 1 will follow the Active Coping Program for Chronic Pain (4 education sessions and 12 physical exercise sessions). Experimental group 2 will receive somatosensory and body schema treatment along with the Active Coping Program.
The study is evaluator-blinded. Statistical analysis will be performed using SPSS version 28 and R Core Team (2023). Statistical significance will be set at p-values <0.05. Authorization will be requested from the relevant Research Ethics Committee.
The results of this study may lead to updates of existing protocols, development of guidelines and manuals for managing chronic musculoskeletal pain, ongoing training for primary care professionals, and publication in high-impact scientific journals to disseminate knowledge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- parallel study for three interventions groups
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: Classic physiotherapy treatment with physical exercise, analgesic electrotherapy and thermotherapyThe patients will receive the usual physiotherapy treatment provided in Primary Care Physiotherapy units, supported by the current Primary Care Physiotherapy protocols of Castilla y León (33), since Andalusia does not currently have any published. The patient will receive 12 sessions of thermotherapy (Infrared/Microwave) and analgesic electrotherapy (analgesic Tens currents) in the painful area(s), and will be prescribed exercises recommended by the Spanish Society of Physical Medicine and Rehabilitation (SERMEF) (34). The learning and execution of the exercises will be supervised by a Primary Care physiotherapist. The sessions will be with a frequency of 2 per week on alternate days for 6 weeks. |
| intervention type 1, education to pain and physical exercise | Experimental | Other: education about pain and physical excersiceThe sessions will be conducted in groups of 10 to 15 patients. * 4 pain science education sessions, each lasting 1.5 hours (6 hours), with one session per week, for 4 weeks. * 12 therapeutic physical exercise program sessions, each lasting 1 hour, to be conducted over 6 weeks (12 hours), with two sessions per week. Although the intervention is group-based, individual instructions will be given to patients. Reference will be made to the content learned in the neuroeducation sessions. The exercise dose must be adjusted to the patient's condition, keeping in mind that, due to the inhibition of the descending pain modulation system, they may experience an initial increase in pain during the first sessions, so as not to alarm the patient and prevent the activity from being discontinued. The main objective is to increase the patient's functionality, an aspect that will be constantly reinforced. The session structure will be as recommended by the American College of Sports Medicine, with se |
| intervention type 2, education to pain and physical exercise with somatosensorial treatment | Experimental | Other: education about pain and physical excersice with somatosensorial treatmentPatients assigned to this group will receive, in addition to the same intervention as the AADC study group "intervention type 2", somatosensory and body schema treatment for the changes observed in an initial assessment during the 4 weeks prior. The prescribed treatment will be repeated daily at home. To facilitate the progress of the treatment, it is recommended that a companion participate in the first session, when possible, where the daily intervention to be performed at home will be explained. If the participation of a companion is not possible, the patient will attend the Health Center's physiotherapy room once a day to be accompanied by the physiotherapist and offered the same treatment opportunities. As a control and monitoring measure, the patient will attend the physiotherapy room once a week and will be called again weekly to verify that the treatment is being performed correctly. They will also be provided with a form to record their home treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Users of the Public Health System of Andalusia, registered in the User Database (BDU) of the Sevilla Health District.
- Ages between 18 and 70.
- Chronic lumbar pain lasting more than 3 months, likely due to central sensitization (likely nociplastic pain).
- The diagnosis of Central Sensitization will be made according to the most recent algorithm published by Nijs et al. in Lancet.
Key exclusion criteria (13 listed)
- Oncological pain (pain related to cancer)
- Spinal fracture or spinal surgery in the previous year.
- Neurological cognitive impairment that prevents understanding of pain neuroeducation (if in doubt, the Minimental Test will be performed, requiring a minimum score of 25)
- Physical conditioning deficit that prevents the execution of the Physical --Education program (minimum requirement: normal execution time of <10 seconds for 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 |
|---|---|---|
| education about pain and physical excersiceThe sessions will be conducted in groups of 10 to 15 patients. * 4 pain science education sessions, each lasting 1.5 hours (6 hours), with one session per week, for 4 weeks. * 12 therapeutic physical exercise program sessions, each lasting 1 hour, to be conducted over 6 weeks (12 hours), with two sessions per week. Although the intervention is group-based, individual instructions will be given to patients. Reference will be made to the content learned in the neuroeducation sessions. The exercise dose must be adjusted to the patient's condition, keeping in mind that, due to the inhibition of the descending pain modulation system, they may experience an initial increase in pain during the first sessions, so as not to alarm the patient and prevent the activity from being discontinued. The main objective is to increase the patient's functionality, an aspect that will be constantly reinforced. The session structure will be as recommended by the American College of Sports Medicine, with se | Other | intervention type 1, education to pain and physical exercise |
| education about pain and physical excersice with somatosensorial treatmentPatients assigned to this group will receive, in addition to the same intervention as the AADC study group "intervention type 2" (education about pain), somatosensory and body schema treatment for the changes observed in an initial assessment during the 4 weeks prior. The prescribed treatment will be repeated daily at home. To facilitate the progress of the treatment, it is recommended that a companion participate in the first session, when possible, where the daily intervention to be performed at home will be explained. If the participation of a companion is not possible, the patient will attend the Health Center's physiotherapy room once a day to be accompanied by the physiotherapist and offered the same treatment opportunities. As a control and monitoring measure, the patient will attend the physiotherapy room once a week and will be called again weekly to verify that the treatment is being performed correctly. They will also be provided with a form to record their home treatment. | Other | intervention type 2, education to pain and physical exercise with somatosensorial treatment |
| Classic physiotherapy treatment with physical exercise, analgesic electrotherapy and thermotherapyThe patients will receive the usual physiotherapy treatment provided in Primary Care Physiotherapy units, supported by the current Primary Care Physiotherapy protocols of Castilla y León, since Andalusia does not currently have any published. The patient will receive 12 sessions of thermotherapy (Infrared/Microwave) and analgesic electrotherapy (analgesic Tens currents) in the painful area(s), and will be prescribed exercises recommended by the Spanish Society of Physical Medicine and Rehabilitation (SERMEF). The learning and execution of the exercises will be supervised by a Primary Care physiotherapist. The sessions will be with a frequency of 2 per week on alternate days for 6 weeks. | Other | control group |
Primary outcome
Change from Baseline in the value of quality of life measured Trough sf 36 questionnaire at 6 Months
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
0 equals very poor quality of life and 100 very good quality of life
16 secondary outcomes
Change from Baseline in the value of pain intensitivity measured trough AVS scale at 6 Months
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of regular physical activity measured Trough international physical activity questionnaire (IPAQ)at 6 Months
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of kinesophobia measured Trough kinesophobia questionnaireTampa-TSK-11SV at 6 Months
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of Pain Catastrophizing measured Trough Pain Catastrophizing Scale (PCS) at 6 Months
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of pain threshold to pressure at 6 Months trough the protocol described in the study by Neziri et al, measuring four points using the procedure described by Fisher
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of Conditional pain modulation system at 6 Months trough Protocol validated by Larsen et al.
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of lumbar disability index measured Trough Rolland Morris Scale at 6 Months
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of Level of severity of the case at 6 Months trough the Central Sensitization Inventory
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of sleep quality and patterns in adults of the case at 6 Months trough The Pittsburgh Sleep Quality Questionnaire (PSQI)
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of Medication intake of the case at 6 Months trough a survey
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
During the follow-up period, visits to the family doctor, emergency services, and specialists will be recorded using the Digital Health Record.
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of satisfaction with health services of the case at 6 Months trough The Spanish version of the Client Satisfaction Questionnaire (CSQ-8)
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of Regular physical activity of the case at 6 Months trough International Physical Activity Questionnaire (IPAQ).
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of fatigue intensitivity measured trough AVS scale at 6 Months
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of short stress test at 6 Months trough number of squats in 30 seconds, 60 seconds, and modified Borg scale of perceived exertion
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
Change from Baseline in the value of Flamingo Balance Test at 6 Months trough number of times you need to land in 30"
Time frame: from the start of treatment, at 11 weeks and at 26 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Background: 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
Related trials for Chronic Pain (Back / Neck)
Not yet recruiting
Virtual Pain Education for Spinal Cord Stimulation Patients
Chronic Pain, Chronic Pain Due to Injury
Not yet recruiting
Differences in Mechanistic Measures (Oxytocin and Cortisol) of Therapeutic Alliance Between A Talk-Based Therapy and Soft-Tissue Mobilization in Individuals With Chronic Spinal Pain
Spine, Low Back Pain
Not yet recruiting
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
Recruiting
A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE
Lumbosacral Radiculopathy, Sciatica
Recruiting
Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
Chronic Back Pain, Chronic Pain (Back / Neck)
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing education about pain and physical excersice, education about pain and physical excersice with somatosensorial treatment and Classic physiotherapy treatment with physical exercise, analgesic electrotherapy and thermotherapy in people with Chronic Pain (Back / Neck), run by Distrito de Atención Primaria Sevilla.
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 4 inclusion and 13 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: opening soon, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the value of quality of life measured Trough sf 36 questionnaire at 6 Months (time frame: from the start of treatment, at 11 weeks and at 26 weeks). 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 NCT07133607, 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 11 Sep 2025.