Spinal Pain SyndromeUCV/PSPSNCT06969456
Managing Chronic Spinal Pain With Exercise and Neuromodulation
A study testing Exercise and TDCS in people with Spinal Pain Syndrome and Chronic Pain (Back / Neck), run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.
Trial summary
Chronic spinal pain is a multifaceted condition frequently characterized by an absence of discernible structural causes, manifesting in symptoms such as significant disability and diminished quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Pain Syndrome, Chronic Pain (Back / Neck)
- What is being tested?
- Exercise and TDCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 27 Oct 2025to 1 Jan 2027
- 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
- Have a diagnostic of PSPS-T2
- Neuropathic pain (DNA4 ≥ 4)
- Patients older than 18 years
- ≥ 6 months with pain
- VAS score ≥ 7
Who cannot join
- Previous or programmed surgeries in abdominal area
- Pregnant or lactating
- Severe fractures or pathologies
- Spine structural deformity
- Neurologic or psychiatric issues
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Borja Huertas Ramirez Juan Vicente Mampel, Phd Studente contact
Spain1 site, 1 recruiting
- Recruiting
Catholic Univerity of Valencia
Valencia, Valencia, 46001
Borja Huertas Ramirez, PhD Student, +34 684098665, juan.vicente@ucv.es
Juan V-M Vicente Mampel, PhD, +34 674177877, juan.vicente@ucv.es
About this study
Official title: Patient-centered Management of Chronic Spinal Pain by Addressing the Peripheral and Central Component With Exercise and Non-invasive Neuromodulation: A Randomized Control Trial (RCT)
Chronic spinal pain is a multifaceted condition frequently characterized by an absence of discernible structural causes, manifesting in symptoms such as significant disability and diminished quality of life. Persistent Spinal Pain Syndrome Type 2 (PSPS-T2) represents a common variant, implicating both peripheral and central nervous system mechanisms. This study investigates the synergistic effects of transcranial direct current stimulation (tDCS) in conjunction with motor control exercises on PSPS-T2 patients who have not responded to conventional treatments. A randomized controlled trial (RCT) will be conducted to compare an experimental group (tDCS + exercise) with a control group (exercise only), with the objective of enhancing functionality, alleviating pain levels, and improving psychological well-being. The findings may contribute to the development of more effective, patient-centered treatment strategies.
Read the detailed description
Chronic spinal pain, characterized by persistent discomfort, frequently lacks discernible structural abnormalities and represents a complex, multifactorial condition. This disorder, manifested by symptoms such as lumbar pain, severe disability, diminished quality of life, and elevated unemployment rates, poses a substantial challenge for treatment. Therapeutic strategies encompass surgical intervention, pharmacological treatments, and conservative methods emphasizing exercise and behavioral therapies. However, the heterogeneous nature of these patients complicates both diagnosis and the assessment of clinical outcomes. Among the diagnostic terms for chronic spinal pain, Persistent Spinal Pain Syndrome (PSPS), particularly PSPS-T2, has garnered attention due to its high prevalence and recurrence in clinical pain management. The complexity of PSPS necessitates a multidisciplinary approach, with a recent shift towards patient-centered care, which has proven effective in reducing both direct and indirect costs associated with these patients. PSPS-T2 has the potential to affect a significant portion of the population, influenced by biological, psychological, and social components. The condition's neuroplasticity involves both peripheral and central mechanisms, which alter the central nervous system's state, contributing to the persistence of pain. Recent advancements in neuromodulatory strategies, such as non-invasive brain stimulation (NIBS), have shown promise in treating spinal pain, particularly in cases associated with neuropathic pain and comorbidities like depression. Additionally, motor control exercises and spinal stabilization have demonstrated efficacy in reducing pain and disability, supporting self-management and improving biopsychosocial beliefs. Combining exercise with NIBS may enhance outcomes, offering an alternative for patients resistant to conventional treatments. This study aims to evaluate the effects of combining neuromodulation (tDCS) with motor control exercises in PSPS-T2 patients. Specifically, we hypothesize that this combined intervention will lead to improvements in functionality, pain reduction, and psychological outcomes, benefiting patients who have not responded to other treatments. A randomized controlled trial (RCT) will be conducted with two groups: an experimental group receiving both tDCS and exercise, and a control group receiving only exercise. The primary objective is to assess baseline characteristics and the effects of the intervention on functionality, pain, psychosocial variables, depression, and quality of life. Secondary objectives include identifying clinical profiles and evaluating the impact of gender, age, and BMI on treatment outcomes. This study is expected to provide valuable insights into the efficacy of combined neuromodulation and exercise for managing PSPS-T2, with potential applications in clinical practice.
- Conditions
- Spinal Pain Syndrome, Chronic Pain (Back / Neck)
- Being tested
- Exercise, TDCS, ShamTDCS
- Keywords
- Chronic spinal pain, neuromodulation, motor control exercises, biopsychosocial approach, disability, quality of life
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
Structured treatment sessions, each lasting 30 minutes, will be organized into distinct blocks. In the initial phases, participants will engage in exercises emphasizing core stabilization and general strength training, with a particular focus on forced expiration as a technique to ensure the proper activation of the transversus abdominis muscle. This methodology aims to mitigate adverse effects associated with increased intra-abdominal pressure. To optimize the activation of the transversus abdominis, patients will be instructed to perform a forced expiration while concurrently drawing the navel inward and upward toward the spine, maintaining the lumbar spine in a neutral position. During the initial exercises, ultrasound imaging of the transversus abdominis will be employed as visual feedback, enabling patients to observe muscle thickening during forced expiration. This visual feedback enhances the accuracy of muscle activation and exercise technique. Exercises will be progressively s
TDCSProcedure or surgery
The transcranial direct current stimulation (tDCS) protocol will involve the application of a continuous current for 30 minutes, with an intensity ranging from 1 to 1.5 mA, targeting the left dorsolateral prefrontal cortex (DLPFC) during each session. Two saline-soaked sponge electrodes, each measuring 35 cm², will be employed to ensure adequate skin contact. In accordance with the international 10-20 EEG electrode placement system, the anodal electrode will be positioned at the F3 location, specifically targeting the left DLPFC. The reference electrode will be placed above the left eye to facilitate efficient current flow through the prefrontal region of the brain. To enhance both safety and efficacy, a 30-second ramp-up and ramp-down period will be incorporated at the commencement and conclusion of the stimulation session. This methodology is intended to minimize potential adverse effects and ensure an optimal stimulation experience for participants.
ShamTDCSProcedure or surgery
The device will be configured to produce an upward gradient for 30 seconds, identical to that used in the experimental group, followed by a downward gradient for another 30 seconds. Consequently, the control group will feel a similar tingling on their scalp as the experimental group. This stimulation will occur for a total of 60 seconds, which is insufficient to induce changes in cortical excitability. Studies have demonstrated that this approach effectively ensures patient blinding.
| Study group | Role | What they receive |
|---|---|---|
| Exercise + TDCS | Experimental | The transcranial direct current stimulation (tDCS) group will undergo 20 minutes of continuous stimulation at an intensity of 1.5 mA over the left dorsolateral prefrontal cortex (DLPFC) during each session. Two saline-soaked sponge electrodes, each measuring 35 cm², will be utilized. In accordance with the international 10-20 EEG electrode placement system, the anodal electrode will be positioned over F3 to specifically target the left DLPFC. The reference electrode will be placed over the left eye to ensure that the current traverses the prefrontal area. A 30-second ramp-up period will be implemented at the commencement of the tDCS stimulation, followed by a 30-second ramp-down period at its conclusion. Receives: Procedure: Exercise; Procedure: TDCS |
| Exercise + ShamTDCS | Placebo comparator | The device will be configured to produce an upward gradient for 30 seconds, identical to that used in the experimental group, followed by a downward gradient for another 30 seconds. Consequently, the control group will feel a similar tingling on their scalp as the experimental group. This stimulation will occur for a total of 60 seconds, which is insufficient to induce changes in cortical excitability. Studies have demonstrated that this approach effectively ensures patient blinding . Receives: Procedure: Exercise; Procedure: ShamTDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is the most widely used and validated assessment tool for low back pain. It is a self-administered questionnaire divided into ten sections designed to evaluate limitations in activities of daily living. Each section is scored on a scale from 0 to 5, with 5 indicating the highest level of disability. The total index score is calculated by dividing the sum of the section scores by the maximum possible score and multiplying by 100, yielding a percentage. The ODI has been validated in Spanish, demonstrating high sensitivity and specificity for functional assessment.
Measured: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
Secondary outcomes (7)
Tampa Scale 11 (TSK-11)
Kinesiophobia is defined as an excessive, irrational, and debilitating fear of physical movement and activity, stemming from a perceived vulnerability to a painful injury or reinjury. Fear of movement has been associated with disability in individuals with chronic pain. The Tampa Scale for Kinesiophobia (TSK) has been shown to predict the degree of disability in patients with chronic pain, with its scores correlating with depression, pain-related fear, and perceived pain intensity. Recently, the use of the TSK-11, a shortened version designed to identify fear-avoidance beliefs in musculoskeletal pain populations, has been recommended. The TSK-11 is scored between 11 and 44 points, with higher scores indicating greater fear of reinjury due to movement. The scale has demonstrated a 90% confidence interval and a reliability coefficient of 0.84.
Measured: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
Catastrophizing
Catastrophizing is understood as a set of negative emotional and cognitive processes that, by themselves, lead to an increase in pain symptoms and fatigue. It also involves a perceived helplessness in coping with pain and an inability to disengage from pain-related thoughts, whether in anticipation or recollection of the painful experience. Catastrophizing comprises three components: rumination, which refers to persistent worry and the inability to suppress thoughts related to pain; magnification, the tendency to exaggerate the unpleasantness of pain and amplify negative thoughts about pain relief; and helplessness, which arises from the perceived inability to cope with painful situations.
To measure the level of catastrophizing in the present study, the Spanish validated version of the Pain Catastrophizing Scale (PCS) was used. This version demonstrates an internal consistency of 0.79 and a test-retest reliability of 0.84. The PCS is a self-administered questionnaire consisting of 1
Measured: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
SF-12
The SF-12 measures Health-Related Quality of Life (HRQoL) and comprises several dimensions: (a) physical functioning, (b) physical role, (c) emotional role, (d) social functioning, (e) bodily pain, and (f) vitality. Additionally, it includes two overarching dimensions that encompass the previous ones: (a) general health and (b) mental health. It is a widely used instrument in the healthcare field and has demonstrated satisfactory psychometric properties, including internal consistency and test-retest reliability.
Measured: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
Visual Analogue Scale (VAS)
The VAS is considered the most representative scale and is regarded as the best option due to its simplicity and ease of use. The version employed in this study ranges from 0 to 10. This scale provides an effective tool for subjectively and discriminatively quantifying pain intensity. A score of 0 indicates no pain as reported by the individual, while 10 represents the worst imaginable pain. Due to these characteristics, the VAS has shown greater utility compared to descriptive or fixed-value scales. The VAS has demonstrated high reliability (Cronbach's α = 0.97) [95% CI = 0.96 to 0.98].
Measured: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
DN4 Questionnaire
The DN4 is one of the most sensitive questionnaires for diagnosing neuropathic pain, demonstrating a high capacity to distinguish between neuropathic and nociceptive pain. The DN4 has been validated in patients with low back pain (LBP) due to disc herniation, spinal stenosis, degenerative disc disease, spinal pain, lumbar spine degeneration, spinal surgery, and lumbar scoliosis. A DN4 cutoff score of 4 yielded a sensitivity of 80% and a specificity of 92% for the diagnosis of neuropathic pain in individuals with LBP. Each patient was asked to describe their pain using the first seven descriptors of neuropathic pain in the DN4, in order to calculate the DN4 interview subscore (range: 0-7).
Measured: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
Beck Depression Inventory
The Beck Depression Inventory - Second Edition (BDI-II) is a self-report instrument consisting of 21 items used to measure the severity of depression in adults and adolescents over the age of 13. This version of the inventory (BDI-II) was developed to assess symptoms corresponding to the criteria for diagnosing depressive disorders outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV; 1994)
Measured: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
The Chronic Pain Self-Efficacy Questionnaire by Martín-Aragón
For this reason, a scale was designed to evaluate self-efficacy expectations regarding symptom management, physical functioning, and pain control. The Chronic Pain Self-Efficacy Questionnaire by Martín-Aragón et al. (1998), validated in Spanish, was used, as its validation results are comparable to those of the original scale by Anderson et al. (1995). This version demonstrates high internal consistency (α = 0.87). The questionnaire consists of 19 items, uses a Likert-type scale, and has a response range from 0 to 10, where 0 represents feeling completely incapable, 5 moderately capable, and 10 fully capable.
Measured: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start27 Oct 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Pain SyndromeStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente Mártir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06969456
- Sponsor's protocol ID
- UCV/2024-2025/031
- Acronym
- UCV/PSPS
- Status last verified
- Apr 2025
- First submitted
- 5 May 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sebaaly A, Lahoud MJ, Rizkallah M, Kreichati G, Kharrat K. Etiology, Evaluation, and Treatment of Failed Back Surgery Syndrome. Asian Spine J. 2018 Jun;12(3):574-585. doi: 10.4184/asj.2018.12.3.574. Epub 2018 Jun 4.
PubMed 29879788Bursali C, Ozkan FU, Kaysin MY, Dortcan N, Aktas I, Kulcu DG. Effectiveness of Repetitive Transcranial Magnetic Stimulation in Patients With Failed Back Surgery Syndrome: A Double-Blind Randomized Placebo-Controlled Study. Pain Physician. 2021 Jan;24(1):E23-E30.
PubMed 33400434Huertas-Ramirez B, Jaenada-Carrilero E, Belda-Antoli M, Leal-Garcia J, Alonso-Martin M, Mahiques-Sanchis A, Benlloch-Garcia A, Falaguera-Vera F, Vicente-Mampel J. Patient-Centered Chronic Spinal Pain Management Using Exercise and Neuromodulation: Study Protocol for a Randomized Controlled Trial. Healthcare (Basel). 2025 Nov 24;13(23):3032. doi: 10.3390/healthcare13233032.
PubMed 41373250
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-centered Management of Chronic Spinal Pain by Addressing the Peripheral and Central Component With Exercise and Non-invasive Neuromodulation: A Randomized Control Trial (RCT)
- ClinicalTrials.gov ID
- NCT06969456
- Acronym / sponsor ID
- UCV/PSPS / UCV/2024-2025/031
- Conditions
- Spinal Pain Syndrome, Chronic Pain (Back / Neck)
- Keywords
- Chronic spinal pain, neuromodulation, motor control exercises, biopsychosocial approach, disability, quality of life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Fundación Universidad Católica de Valencia San Vicente MártirUniversity, hospital or other
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 13 May 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.
Chronic spinal pain is a multifaceted condition frequently characterized by an absence of discernible structural causes, manifesting in symptoms such as significant disability and diminished quality of life. Persistent Spinal Pain Syndrome Type 2 (PSPS-T2) represents a common variant, implicating both peripheral and central nervous system mechanisms. This study investigates the synergistic effects of transcranial direct current stimulation (tDCS) in conjunction with motor control exercises on PSPS-T2 patients who have not responded to conventional treatments. A randomized controlled trial (RCT) will be conducted to compare an experimental group (tDCS + exercise) with a control group (exercise only), with the objective of enhancing functionality, alleviating pain levels, and improving psychological well-being. The findings may contribute to the development of more effective, patient-centered treatment strategies.
Detailed description
Chronic spinal pain, characterized by persistent discomfort, frequently lacks discernible structural abnormalities and represents a complex, multifactorial condition. This disorder, manifested by symptoms such as lumbar pain, severe disability, diminished quality of life, and elevated unemployment rates, poses a substantial challenge for treatment. Therapeutic strategies encompass surgical intervention, pharmacological treatments, and conservative methods emphasizing exercise and behavioral therapies. However, the heterogeneous nature of these patients complicates both diagnosis and the assessment of clinical outcomes. Among the diagnostic terms for chronic spinal pain, Persistent Spinal Pain Syndrome (PSPS), particularly PSPS-T2, has garnered attention due to its high prevalence and recurrence in clinical pain management. The complexity of PSPS necessitates a multidisciplinary approach, with a recent shift towards patient-centered care, which has proven effective in reducing both direct and indirect costs associated with these patients. PSPS-T2 has the potential to affect a significant portion of the population, influenced by biological, psychological, and social components. The condition's neuroplasticity involves both peripheral and central mechanisms, which alter the central nervous system's state, contributing to the persistence of pain. Recent advancements in neuromodulatory strategies, such as non-invasive brain stimulation (NIBS), have shown promise in treating spinal pain, particularly in cases associated with neuropathic pain and comorbidities like depression. Additionally, motor control exercises and spinal stabilization have demonstrated efficacy in reducing pain and disability, supporting self-management and improving biopsychosocial beliefs. Combining exercise with NIBS may enhance outcomes, offering an alternative for patients resistant to conventional treatments. This study aims to evaluate the effects of combining neuromodulation (tDCS) with motor control exercises in PSPS-T2 patients. Specifically, we hypothesize that this combined intervention will lead to improvements in functionality, pain reduction, and psychological outcomes, benefiting patients who have not responded to other treatments. A randomized controlled trial (RCT) will be conducted with two groups: an experimental group receiving both tDCS and exercise, and a control group receiving only exercise. The primary objective is to assess baseline characteristics and the effects of the intervention on functionality, pain, psychosocial variables, depression, and quality of life. Secondary objectives include identifying clinical profiles and evaluating the impact of gender, age, and BMI on treatment outcomes. This study is expected to provide valuable insights into the efficacy of combined neuromodulation and exercise for managing PSPS-T2, with potential applications in clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise + TDCS | Experimental | Procedure: Exercise, Procedure: TDCSThe transcranial direct current stimulation (tDCS) group will undergo 20 minutes of continuous stimulation at an intensity of 1.5 mA over the left dorsolateral prefrontal cortex (DLPFC) during each session. Two saline-soaked sponge electrodes, each measuring 35 cm², will be utilized. In accordance with the international 10-20 EEG electrode placement system, the anodal electrode will be positioned over F3 to specifically target the left DLPFC. The reference electrode will be placed over the left eye to ensure that the current traverses the prefrontal area. A 30-second ramp-up period will be implemented at the commencement of the tDCS stimulation, followed by a 30-second ramp-down period at its conclusion. |
| Exercise + ShamTDCS | Placebo comparator | Procedure: Exercise, Procedure: ShamTDCSThe device will be configured to produce an upward gradient for 30 seconds, identical to that used in the experimental group, followed by a downward gradient for another 30 seconds. Consequently, the control group will feel a similar tingling on their scalp as the experimental group. This stimulation will occur for a total of 60 seconds, which is insufficient to induce changes in cortical excitability. Studies have demonstrated that this approach effectively ensures patient blinding . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a diagnostic of PSPS-T2
- Neuropathic pain (DNA4 ≥ 4)
- Patients older than 18 years
- ≥ 6 months with pain
- VAS score ≥ 7
Key exclusion criteria (5 listed)
- Previous or programmed surgeries in abdominal area
- Pregnant or lactating
- Severe fractures or pathologies
- Spine structural deformity
- Neurologic or psychiatric issues
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 |
|---|---|---|
| ExerciseStructured treatment sessions, each lasting 30 minutes, will be organized into distinct blocks. In the initial phases, participants will engage in exercises emphasizing core stabilization and general strength training, with a particular focus on forced expiration as a technique to ensure the proper activation of the transversus abdominis muscle. This methodology aims to mitigate adverse effects associated with increased intra-abdominal pressure. To optimize the activation of the transversus abdominis, patients will be instructed to perform a forced expiration while concurrently drawing the navel inward and upward toward the spine, maintaining the lumbar spine in a neutral position. During the initial exercises, ultrasound imaging of the transversus abdominis will be employed as visual feedback, enabling patients to observe muscle thickening during forced expiration. This visual feedback enhances the accuracy of muscle activation and exercise technique. Exercises will be progressively s | Procedure or surgery | Exercise + ShamTDCS, Exercise + TDCS |
| TDCSThe transcranial direct current stimulation (tDCS) protocol will involve the application of a continuous current for 30 minutes, with an intensity ranging from 1 to 1.5 mA, targeting the left dorsolateral prefrontal cortex (DLPFC) during each session. Two saline-soaked sponge electrodes, each measuring 35 cm², will be employed to ensure adequate skin contact. In accordance with the international 10-20 EEG electrode placement system, the anodal electrode will be positioned at the F3 location, specifically targeting the left DLPFC. The reference electrode will be placed above the left eye to facilitate efficient current flow through the prefrontal region of the brain. To enhance both safety and efficacy, a 30-second ramp-up and ramp-down period will be incorporated at the commencement and conclusion of the stimulation session. This methodology is intended to minimize potential adverse effects and ensure an optimal stimulation experience for participants. | Procedure or surgery | Exercise + TDCS |
| ShamTDCSThe device will be configured to produce an upward gradient for 30 seconds, identical to that used in the experimental group, followed by a downward gradient for another 30 seconds. Consequently, the control group will feel a similar tingling on their scalp as the experimental group. This stimulation will occur for a total of 60 seconds, which is insufficient to induce changes in cortical excitability. Studies have demonstrated that this approach effectively ensures patient blinding. | Procedure or surgery | Exercise + ShamTDCS |
Primary outcome
The Oswestry Disability Index (ODI)
Time frame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
The Oswestry Disability Index (ODI) is the most widely used and validated assessment tool for low back pain. It is a self-administered questionnaire divided into ten sections designed to evaluate limitations in activities of daily living. Each section is scored on a scale from 0 to 5, with 5 indicating the highest level of disability. The total index score is calculated by dividing the sum of the section scores by the maximum possible score and multiplying by 100, yielding a percentage. The ODI has been validated in Spanish, demonstrating high sensitivity and specificity for functional assessment.
7 secondary outcomes
Tampa Scale 11 (TSK-11)
Time frame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
Catastrophizing
Time frame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
SF-12
Time frame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
Visual Analogue Scale (VAS)
Time frame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
DN4 Questionnaire
Time frame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
Beck Depression Inventory
Time frame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
The Chronic Pain Self-Efficacy Questionnaire by Martín-Aragón
Time frame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up
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 8 Dec 2025.
- Background: PubMed 29879788Sebaaly A, Lahoud MJ, Rizkallah M, Kreichati G, Kharrat K. Etiology, Evaluation, and Treatment of Failed Back Surgery Syndrome. Asian Spine J. 2018 Jun;12(3):574-585. doi: 10.4184/asj.2018.12.3.574. Epub 2018 Jun 4.
- Background: PubMed 33400434Bursali C, Ozkan FU, Kaysin MY, Dortcan N, Aktas I, Kulcu DG. Effectiveness of Repetitive Transcranial Magnetic Stimulation in Patients With Failed Back Surgery Syndrome: A Double-Blind Randomized Placebo-Controlled Study. Pain Physician. 2021 Jan;24(1):E23-E30.
- Derived from this study: PubMed 41373250Huertas-Ramirez B, Jaenada-Carrilero E, Belda-Antoli M, Leal-Garcia J, Alonso-Martin M, Mahiques-Sanchis A, Benlloch-Garcia A, Falaguera-Vera F, Vicente-Mampel J. Patient-Centered Chronic Spinal Pain Management Using Exercise and Neuromodulation: Study Protocol for a Randomized Controlled Trial. Healthcare (Basel). 2025 Nov 24;13(23):3032. doi: 10.3390/healthcare13233032.
- 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.
Borja Huertas Ramirez Juan Vicente Mampel, Phd Studente contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and TDCS in people with Spinal Pain Syndrome and Chronic Pain (Back / Neck), run by Fundación Universidad Católica de Valencia San Vicente Mártir 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 Dec 2025. 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. Some participants in this study may receive a placebo. 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?
Contact Borja Huertas Ramirez Juan Vicente Mampel, Phd Studente (+34 684098665, borja.huertas@mail.ucv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Oswestry Disability Index (ODI) (time frame: Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month 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 NCT06969456, which also lists 3 linked publications.
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 8 Dec 2025; AzTrials last refreshed its copy on 2 Nov 2026.