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Failed Back Surgery SyndromeNCT06272539

Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome

A study testing Exercise and Spinal Cord Stimulation in people with Failed Back Surgery Syndrome, run by Fundación Universidad Católica de Valencia San Vicente Mártir at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction. At the neurophysiological level, it is possible to observe an increase in the central processing of pain in patients diagnosed with persistent Spinal Pain Syndrome (PSPS-T1/2), potentially stemming from dysfunctions in the endogenous facilitation and inhibition of pain. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Failed Back Surgery Syndrome
What is being tested?
Exercise and Spinal Cord Stimulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteSpain
Study dates
9 Apr 2024to 9 Jun 2026
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have a diagnostic of PSPS-T1/2 with leg pain and back pain,
  • Patients older than 18 years
  • 6 months with pain
  • Visual Analogue Scale score >7
  • Spanish native language

Who cannot join

  • Previous 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.

Spain1 site

  • Juan Vicente-Mampel

    Torrent, Valencia, 46900

Other trials in Spain

About this study

Official title: Spinal Cord Stimulation Combined With Exercise in Patients Diagnosed With Persistent Spinal Pain Syndrome. A Randomized Control Trial (RCT)

Introduction. At the neurophysiological level, it is possible to observe an increase in the central processing of pain in patients diagnosed with persistent Spinal Pain Syndrome (PSPS-T1/2), potentially stemming from dysfunctions in the endogenous facilitation and inhibition of pain. Administration of high doses of spinal cord stimulation to individuals with PSPS-T1/2 may induce supraspinal descending activation. Similarly, exercise is recognized as a fundamental aspect of spinal pain management. Studies have demonstrated its impact on neurophysiological factors, including the release of spinal and supraspinal beta-endorphins, which activate μ-opioid receptors. Therefore, the purpose of this study will be to examine the effect of SCS in combination with lumbo-pelvic stability core training on perceived low back pain, quality of life and disability in failed back surgery syndrome (FBSS) patients. Methods/Materials. A double-blind randomized clinical trial (RCT) has been designed. All participants will be randomized from a pre-set sequence. The intervention design has been elaborated from the CONSORT guidelines. This study protocol has been approved by the Ethics Committee in research of Salamanca Health Area (protocol number PI 2023 101435 in (24/01/2024) in accordance with the ethical guidelines of the Helsinki declaration. Sample size was calculated using G Power® Sample size software (University of Düsseldorf). The calculation was based on a moderate effect size of 0.4 (partial η2 = 0.40, α = .05, power = 0.90), resulting in a total of 28 patients. Assuming a 30% dropout rate, 36 participants will be recruited in total. Two sessions per week will be scheduled for 8 weeks with a total of 16 sessions. Each work session will have a duration of 60 minutes. The exercise will be adapted according to the phases based on the results already published, limiting in each phase the degrees of flexion and extension of the spine in order to avoid the risk of electrode migration. Primary outcomes will be functionality, satisfaction, strength, psychosocial variables, quality of life and pain perception.

Being tested
Exercise, Spinal Cord Stimulation
Keywords
Spinal Cord Stimulation, Exercise
Medical subject headings
Failed Back Surgery Syndrome, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ExerciseProcedure or surgery

    The exercise The exercise will be adapted according to the phases based on the results already published, limiting in each phase the degrees of flexion and extension of the spine in order to avoid the risk of electrode migration.

  • Spinal Cord StimulationProcedure or surgery

    Spinal cord stimulation (SCS) involves an implantable pulse generator with the potential for enhanced therapeutic success through stimulation algorithms and parameters (28). Spinal cord stimulation (SCS) targeting distal areas, such as the dorsal root ganglion, may offer greater anatomical specificity in therapy

Study groups in NCT06272539
Study groupRoleWhat they receive
Spinal Cord StimulationActive comparatorSpinal cord stimulation (SCS) involves an implantable pulse generator with the potential for enhanced therapeutic success through stimulation algorithms and parameters (28). Spinal cord stimulation (SCS) targeting distal areas, such as the dorsal root ganglion, may offer greater anatomical specificity in therapy. Subthreshold stimulation, utilizing high-frequency or burst energy delivery, has the potential to eliminate noxious and off-target paresthesiae. Recent studies have demonstrated that subthreshold stimulation at high frequencies and/or utilizing different stimulation paradigms can provide equal or even superior pain relief compared to standard SCS (29). The procedure entails the placement of two octapolar electrodes inserted through the epidural space, positioned beneath the dorsal area posterior to the spinal cord's posterior horn.
Receives: Procedure: Spinal Cord Stimulation
Spinal Cord Stimulation+ExerciseExperimentalThe experimental group will perform a Lumbo-pelvic core stability training program combined with motor control exercises through specific therapeutic exercises of the lumbopelvic centre combined with neurostimulation treatment. The exercise will be adapted according to the phases based on the results already published, the following intervention plan has been designed. Additionally, in each of the phases, the exercises were designed, limiting the degree of flexion/extension and lumbar traction of the exercises. Two weekly sessions will be scheduled during 8 weeks with a total of 24 sessions, each one of 60 minutes of duration. A certified physiotherapist in exercised with at least 10 years of clinical practice has applied treatment.
Receives: Procedure: Exercise; Procedure: Spinal Cord Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disability (Oswestry Disability Index)

    The Oswestry Disability Index (ODI) is the most used and validated assessment test for lumbar pain. Is a self-assessment test divided in ten sections designed to assess the limitations in daily life

    Measured: at baseline, Post3weeks, Post2months, Post6months

  2. Perception Pain (Visual analogue scale)

    This scale is an efficient tool to quantify in a subjective and selective way this range in which 0 is considered a total absence of pain and 10 the worst pain imaginable

    Measured: at baseline, Post3weeks, Post2months, Post6months

Secondary outcomes (6)

  1. Quality of life (Short Form 36 Health Survey, SF36)

    The measures the quality of life and comprises several dimensions: (a) physical functioning, (b) role physical, (c) role emotional, (d) social functioning, (e) bodily pain and (f) vitality. Scores for each component summary are calculated based on responses to the twelve items, with higher scores indicating better health-related quality of life.

    Measured: at baseline, Post3weeks, Post2months, Post6months

  2. Patient's satisfaction

    There are already published studies about diagnosed patients that evaluate their satisfaction using a numeric scale of 11 (-5 to 5) (37,38). High scores show the patient's satisfaction with the treatment.

    Measured: at baseline, Post3weeks, Post2months, Post6months

  3. Strength (Sorensen Test)

    Sorensen test it measures the amount of strength and resistance of the back extensors

    Measured: at baseline, Post3weeks, Post2months, Post6months

  4. Fear of Movement (Tampa Scale of Kinesiophobia, TSK)

    The Tampa Scale of Kinesiophobia (TSK) was used to measure fear of movement or reinjury. Scores on the TSK are calculated by summing responses to individual items, with higher scores indicating greater levels of kinesiophobia. The scale has been validated and widely used in research and clinical settings to assess and monitor fear of movement in individuals with chronic pain conditions, musculoskeletal injuries, and other conditions where fear of movement may impact rehabilitation or daily functioning.

    Measured: at baseline, Post3weeks, Post2months, Post6months

  5. Individual's belief in their own ability to successfully execute tasks (Self-efficacy Scale)

    The Self-Efficacy Scale is a tool used to measure an individual's belief in their own ability to successfully execute tasks and achieve goals in specific situations.

    The scale typically consists of items that assess an individual's perceived self-efficacy in various domains or activities, such as academic performance, athletic ability, social interactions, or coping with challenges. Respondents rate their confidence levels on a Likert scale, indicating the extent to which they believe they can successfully perform tasks or overcome obstacles.

    Scores on the Self-Efficacy Scale are calculated by summing responses to individual items, with higher scores indicating greater perceived self-efficacy in the specified domains.

    Measured: at baseline, Post3weeks, Post2months, Post6months

  6. Catastrophic thinking (Pain Catastrophizing Scale)

    The Pain Catastrophizing Scale (PCS), a self-administered questionnaire (13 items on a Likert-type scale from 0 to 4) was used in this study to assess the level of catastrophizing in the presence of pain

    Measured: at baseline, Post3weeks, Post2months, Post6months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2024
  2. Study start9 Apr 2024
  3. Primary completion1 Jan 2026
  4. Study completion9 Jun 2026

Resources

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
Care provider, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06272539
Sponsor's protocol ID
2023 101435
Other IDs
2023
Status last verified
Aug 2024
First submitted
15 Feb 2024
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Othman R, Dassanayake S, Jayakaran P, Tumilty S, Swain N, Mani R. Relationships Between Psychological, Social, Physical Activity, and Sleep Measures and Somatosensory Function in Individuals With Spinal Pain: A Systematic Review and Meta-analysis. Clin J Pain. 2020 Feb;36(2):124-134. doi: 10.1097/AJP.0000000000000775.

    PubMed 31764166

  • Baber Z, Erdek MA. Failed back surgery syndrome: current perspectives. J Pain Res. 2016 Nov 7;9:979-987. doi: 10.2147/JPR.S92776. eCollection 2016.

    PubMed 27853391

  • Christelis N, Simpson B, Russo M, Stanton-Hicks M, Barolat G, Thomson S, Schug S, Baron R, Buchser E, Carr DB, Deer TR, Dones I, Eldabe S, Gallagher R, Huygen F, Kloth D, Levy R, North R, Perruchoud C, Petersen E, Rigoard P, Slavin K, Turk D, Wetzel T, Loeser J. Persistent Spinal Pain Syndrome: A Proposal for Failed Back Surgery Syndrome and ICD-11. Pain Med. 2021 Apr 20;22(4):807-818. doi: 10.1093/pm/pnab015.

    PubMed 33779730

  • Nijs J, Meeus M, Cagnie B, Roussel NA, Dolphens M, Van Oosterwijck J, Danneels L. A modern neuroscience approach to chronic spinal pain: combining pain neuroscience education with cognition-targeted motor control training. Phys Ther. 2014 May;94(5):730-8. doi: 10.2522/ptj.20130258. Epub 2014 Jan 30.

    PubMed 24481595

  • Cho JH, Lee JH, Song KS, Hong JY. Neuropathic Pain after Spinal Surgery. Asian Spine J. 2017 Aug;11(4):642-652. doi: 10.4184/asj.2017.11.4.642. Epub 2017 Aug 7.

    PubMed 28874984

Questions about this trial

What is this clinical trial studying?

A study testing Exercise and Spinal Cord Stimulation in people with Failed Back Surgery Syndrome, 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: finished, as of the sponsor's last update on 7 Jul 2026. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Disability (Oswestry Disability Index) (time frame: at baseline, Post3weeks, Post2months, Post6months). The study lists 2 primary outcomes in all. 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 NCT06272539, which also lists 5 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 7 Jul 2026; AzTrials last refreshed its copy on 31 Oct 2026.

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