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

What this Trial Is About

Researchers are evaluating the effects of spinal cord stimulation combined with lumbo-pelvic stability core training on patients diagnosed with persistent spinal pain syndrome type 1 or 2 (PSPS-T1/2), also known as failed back surgery syndrome (FBSS). This condition involves increased central pain processing, possibly caused by dysfunction in the body's natural pain control systems. The study aims to understand how these treatments affect pain perception, quality of life, disability, and other related factors in these patients. Participants will be randomly assigned to receive either spinal cord stimulation (SCS) alone or SCS combined with specific exercise therapy. The SCS treatment involves implanting electrodes near the spinal cord to deliver electrical pulses aimed at modulating pain signals. The exercise program consists of lumbo-pelvic core stability and motor control exercises, adapted in phases to limit spinal flexion and extension to prevent electrode migration. The exercise sessions will occur twice a week for eight weeks, with each session lasting 60 minutes, totaling 24 sessions. Throughout the study, participants will undergo assessments at baseline, 3 weeks, 2 months, and 6 months. These evaluations include disability using the Oswestry Disability Index, pain perception via a visual analogue scale, quality of life surveys, patient satisfaction, muscle strength tests, and psychological measures such as fear of movement, self-efficacy, and catastrophic thinking. The research team will monitor progress closely to track changes over time and study the combined impact of the treatments on participants' wellbeing.

Spinal Cord Stimulation Combined With Exercise in Persistent Spinal Pain Syndrome