Clinical trial NCT06272539: Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome
Official title: Spinal Cord Stimulation Combined With Exercise in Patients Diagnosed With Persistent Spinal Pain Syndrome. A Randomized Control Trial (RCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Failed Back Surgery Syndrome
Keywords: Spinal Cord Stimulation
Exercise
Lead sponsor: Fundación Universidad Católica de Valencia San Vicente Mártir
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Biomédica de Salamanca
First posted: 2024-02-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Previous surgeries in abdominal area
* Pregnant or lactating
* Severe fractures or pathologies
* Spine structural deformity
* Neurologic or psychiatric issues.

Primary outcomes:
measure: Disability (Oswestry Disability Index)
timeFrame: at baseline, Post3weeks, Post2months, Post6months
measure: Perception Pain (Visual analogue scale)
timeFrame: at baseline, Post3weeks, Post2months, Post6months
Secondary outcomes:
measure: Quality of life (Short Form 36 Health Survey, SF36)
timeFrame: at baseline, Post3weeks, Post2months, Post6months
measure: Patient's satisfaction
timeFrame: at baseline, Post3weeks, Post2months, Post6months
measure: Strength (Sorensen Test)
timeFrame: at baseline, Post3weeks, Post2months, Post6months
measure: Fear of Movement (Tampa Scale of Kinesiophobia, TSK)
timeFrame: at baseline, Post3weeks, Post2months, Post6months
measure: Individual's belief in their own ability to successfully execute tasks (Self-efficacy Scale)
timeFrame: at baseline, Post3weeks, Post2months, Post6months
measure: Catastrophic thinking (Pain Catastrophizing Scale)
timeFrame: at baseline, Post3weeks, Post2months, Post6months
Other outcomes:
Locations:
city: Torrent
country: Spain
facility: Juan Vicente-Mampel
state: Valencia
Study officials:
affiliation: Complejo Asistencial Universitario de Salamanca. Unidad del Dolor
name: Francisco J Sanchez Montero
role: PRINCIPAL_INVESTIGATOR
affiliation: Catholic University of Valencia
name: Juan Vicente-Mampel
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.