Burst Spinal Cord Stimulation (Burst-SCS) Study

Change in Short-Form McGill Pain Questionnaire (SFMPQ) Score

The Short-Form McGill Pain Questionnaire (SFMPQ) assesses the quality and intensity of pain using 15 descriptors representing sensory (11 items) and affective (4 items) dimensions of pain. Each descriptor is rated on a 4-point intensity scale where 0=none, 1=mild, 2=moderate, and 3=severe. The total scores are calculated by summing the intensity ratings for each of the 15 descriptors (possible score range 0 to 45). Higher scores indicate more severe pain symptoms. Change from baseline scores are calculated as the follow-up score minus the baseline score, where negative values indicate improvement (reduced pain; better outcome) and positive values indicate worsening (increased pain; worse outcome). Results were aggregated from all interventions regardless of treatment order and reflect the total difference from baseline.

Time frame: Up to one month following the pre-implant visit.

Change in General Pain Disability Index (PDI) Score

Pain-related disability was assessed using the six-item General Pain Disability Index (PDI) Questionnaire, which measures the degree to which chronic pain disrupts various aspects of daily life. Each item is rated on a 0-10 scale where 0 indicates no disability and 10 indicates total disability in that activity due to pain. The total score ranges from 0 to 60, with higher scores indicating greater pain-related disability. Change from baseline scores are calculated as the follow-up score minus the baseline score, where negative values indicate improvement (reduced pain-disability) and positive values indicate worsening (increased pain-related disability). Results were aggregated from all interventions regardless of treatment order and reflect the total difference from baseline.

Time frame: Up to one month following the pre-implant visit.

Change in Brief Pain Inventory-Short Form (BPI-SF) Score

The Brief Pain Inventory-Short Form (BPI-SF) assesses pain severity and pain interference with daily functioning. It includes four items assessing pain severity (worst, least, average, current) and seven items assessing interference (general activity, mood, walking, work, relations, sleep, enjoyment of life). Each item is rated 0 (no pain/interference) to 10 (worst pain/interferes completely). A total composite BPI-SF score was calculated by summing severity (range 0-40) and interference (range 0-70) domains for a total score of 0-110. Higher scores indicate greater pain burden and impairment. Change from baseline was calculated as follow-up score minus baseline score, where negative values indicate improvement. Results were aggregated from all interventions regardless of treatment order and reflect the total difference from baseline.

Time frame: Up to one month following the pre-implant visit.

Michigan Body Map (MBM)

MBM was used to assess body areas where chronic pain was experienced and quantify the degree of widespread body pain (i.e. pain centralization). Pain spread was collected by having participants check all areas of the body as outlined on the body map where they felt persistent or recurrent pain. A checked box meant pain was present in that region of the body. The MBM had 35 boxes total participants could check, which were summed together to assess participants' pain. Lower number of checked boxes indicated less widespread pain; higher number of checked boxes indicated more widespread pain. Change from baseline scores are calculated as the follow-up score minus the baseline score, where negative values indicate improvement (reduced pain areas) and positive values indicate worsening (increased pain areas). Results were aggregated from all interventions regardless of treatment order and reflect the total difference from baseline.

Time frame: Up to one month following the pre-implant visit.

Fibromyalgia Survey Questionnaire (FSQ) - Widespread Pain Index

Pain distribution was assessed using the Widespread Pain Index (WPI) component of the Fibromyalgia Survey Questionnaire (FSQ). The WPI is a 19-item checklist that evaluates the presence of pain or tenderness in specific body regions experienced during the past 7 days. Participants indicate whether they experienced pain in each of 19 anatomical areas including: bilateral shoulder, upper arm, lower arm, hip, upper leg, lower leg, and jaw; plus neck, upper back, lower back, chest, and abdomen. Each painful area receives a score of 1, with the total WPI score ranging from 0 to 19, where higher scores indicate more widespread pain distribution. Change from baseline scores are calculated as the follow-up score minus the baseline score, where negative values indicate improvement (reduced pain areas) and positive values indicate worsening (increased pain areas). Results were aggregated from all interventions regardless of treatment order and reflect the total diff

Time frame: Up to one month following the pre-implant visit.

Fibromyalgia Survey Questionnaire (FSQ) - Symptom Severity Index

Symptom severity was assessed using the Symptom Severity Index component of the Fibromyalgia Survey Questionnaire (FSQ). The Symptom Severity Index evaluates fibromyalgia-related symptoms through two sections: (1) a three-item scale assessing fatigue, trouble thinking or remembering, and waking up tired over the past week, each rated on a 0-3 scale (0 = no problem, 1 = slight/mild, 2 = moderate, 3 = severe); and (2) a three-item checklist evaluating the presence of lower abdominal pain/cramps, depression, and headache over the past 6 months (0 = absent, 1 = present). The total Symptom Severity Index score ranges from 0 to 12, with higher scores indicating greater symptom severity. Change from baseline scores are calculated as the follow-up score minus the baseline score, where negative values indicate improvement and positive values indicate worsening. Results were aggregated from all interventions regardless of treatment order and reflect the total difference from baseline.

Time frame: Up to one month following the pre-implant visit.