10-kHz High-Frequency Spinal Cord Stimulation for Adults With Chronic Noncancer Pain: A Health Technology Assessment.
Bibliographic record
Abstract
BACKGROUND: Chronic pain is costly for patients and for the health care system. It negatively affects people's physical, emotional, social, and mental health. We conducted a health technology assessment of 10-kHz high-frequency spinal cord stimulation (SCS) in adults with chronic noncancer pain that was refractory to medical management, which included an evaluation of effectiveness, safety, cost-effectiveness, the budget impact of publicly funding 10-kHz high-frequency SCS, and patient preferences and values. METHODS: We performed a systematic literature search of the clinical evidence. We assessed the risk of bias of each included study using the Cochrane Risk of Bias and ROBINS-I tools and the quality of the body of evidence according to the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) Working Group criteria. We performed a systematic economic literature search. We analyzed the 5-year budget impact of publicly funding 10-kHz high-frequency SCS in Ontario for adults with chronic noncancer pain who had already tried other available SCS therapies (up to 1.2 kHz). To contextualize the potential value of 10-kHz high-frequency SCS, we spoke with people who had chronic noncancer pain. RESULTS: We included 5 studies (7 publications) in the clinical evidence review. Overall, 10-kHz high-frequency SCS likely provides reductions in pain intensity and functional disability, and improvements in quality of life in people with chronic noncancer pain (GRADE: Moderate). As well, patients may reduce their opioid consumption with 10-kHz high-frequency SCS (GRADE: Low). The two included economic evaluations found that 10-kHz high-frequency SCS was cost-saving compared with conventional SCS, but neither was applicable to the Ontario context. Owing to limited evidence about the effectiveness of 10-kHz high-frequency SCS in people who have first tried and failed SCS at lower frequencies (up to 1.2 kHz), we did not conduct a cost-effectiveness analysis comparing this pathway of care and 10-kHz high-frequency SCS for Ontario. Publicly funding 10-kHz high-frequency SCS (using the Freedom SCS system) in Ontario over the next 5 years would lead to a total net cost savings of $0.73 million (ranging from about $0.10 million in year 1 to about $0.21 million in year 5). However, if the province outsourced this therapy using the Senza HF10 SCS system, the total 5-year budget impact would be about $8.76 million. The people we spoke with who had chronic noncancer pain reported that their pain had a substantial negative impact on their activities and emotional well-being. Their direct knowledge of different pain therapies allowed them to provide context and comparisons when they discussed the impact of SCS on their chronic pain. CONCLUSIONS: For adults with chronic noncancer pain that was refractory to medical management, 10-kHz high-frequency SCS was effective in relieving pain, reducing disability, and improving quality of life. Because there was limited evidence about the effectiveness of 10-kHz high-frequency SCS in people who had first tried and failed SCS at lower frequencies (up to 1.2 kHz), we were unable to determine whether 10-kHz high-frequency SCS is cost-effective in the Ontario context. We estimate that publicly funding 10-kHz high-frequency SCS in Ontario would result in cost savings of about $0.10 million to $0.21 million per year, for a potential total 5-year net cost savings of about $0.73 million. Although people with chronic noncancer pain knew little about SCS before they received it, they reported that it reduced their level of chronic pain, leading to improvements in function and their ability to perform activities of daily living.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.034 | 0.109 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.006 | 0.013 |
| Bibliometrics | 0.017 | 0.011 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.005 | 0.003 |
| Open science | 0.002 | 0.003 |
| Research integrity | 0.004 | 0.002 |
| Insufficient payload (model declined to judge) | 0.003 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".