Managing Chronic Spinal Pain With Exercise and Neuromodulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFundación Universidad Católica de Valencia San Vicente Mártir
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a diagnostic of PSPS-T2
Neuropathic pain (DNA4 ≥ 4)
Patients older than 18 years
≥ 6 months with pain
Disqualifiers
Previous or programmed surgeries in abdominal area
Pregnant or lactating
Severe fractures or pathologies
Spine structural deformity
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise
Procedure/SurgeryStructured 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
TDCS
Procedure/SurgeryThe 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.
ShamTDCS
Procedure/SurgeryThe 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.
Treatment groups
42 Participants
are divided into 2 treatment groupsGroup A: Exercise + TDCSExperimental treatment 2 interventions
Group B: Exercise + ShamTDCSPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-upSecondary outcomes
1
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.
Time frame
Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up2
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
Time frame
Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up3
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.
Time frame
Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-up4
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) \[95% CI = 0.96 to 0.98\].
Time frame
Pre-treatment, 1-month follow-up, 3-month follow-up, 6-month follow-upSponsors and contacts
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Source ClinicalTrials.gov