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Researchers are investigating the effects of combining spinal cord stimulation (SCS) with lumbo-pelvic stability core exercise training on patients diagnosed with persistent spinal pain syndrome (PSPS-T1/2), also known as failed back surgery syndrome. This condition involves increased central processing of pain, potentially due to dysfunctions in the body's natural pain control mechanisms. The study aims to evaluate how this combined approach impacts perceived low back pain, quality of life, and disability in these patients. The study is a double-blind randomized clinical trial involving 36 participants aged 18 to 80 years with persistent pain for at least 6 months and a pain score above 7 on the Visual Analogue Scale. Participants will receive two sessions per week for eight weeks, totaling 16 sessions of 60 minutes each. The exercise program will be carefully adapted in phases to limit spinal flexion and extension, reducing the risk of electrode migration from the implanted spinal cord stimulator. The spinal cord stimulation device used includes an implantable pulse generator targeting specific areas such as the dorsal root ganglion for enhanced therapy. Throughout the study, researchers will assess disability using the Oswestry Disability Index and measure pain perception with the Visual Analogue Scale at baseline, after 3 weeks, 2 months, and 6 months. Other outcomes include functionality, satisfaction, strength, psychosocial factors, and quality of life. The trial follows ethical guidelines and has been approved by the relevant ethics committee. The total study duration includes the 8-week treatment period and follow-up assessments extending to 6 months post-treatment.

Age: 18Years - 80YearsAll GendersPhase Not Applicable
1 location
Clinical trials in Torrent | DecenTrialz