Pain and quality of life in patients with critical limb ischaemia: results of a randomized controlled multicentre study on the effect of spinal cord stimulation
Bibliographic record
Abstract
We carried out an assessment of pain and quality of life of patients with critical limb ischaemia during the follow-up of a multicentre randomized trial in more detail than previously reported. In a multicentre clinical trial 120 patients were randomized between medical treatment and medical treatment plus spinal cord stimulation. Patients were selected on the basis of clinical symptoms and macrocirculatory data as described in the European consensus document on critical limb ischaemia. Data were collected at intake and then 1, 3, 6, 12 and 18 months later. Primary outcome measures were limb salvage, pain relief and quality of life. Patient and limb survival was estimated with the Kaplan-Meier method. Pain was evaluated using the visual analogue scale (VAS), the McGill pain questionnaire, the pain score of the Nottingham Health Profile (NHP) and the use of analgesics. Quality of life was evaluated using the NHP, the EuroQol and mobility subscore of the Sickness Impact Profile. The 2-year limb survival was 52% for SCS treatment and 46% for standard treatment (p =0.47). Pain relief was considerable in both treatment strategies (p<0.005) with no significant differences between the strategies. The improvement occurred within the first few months and remained stable during further follow-up. Patients with SCS used fewer non-narcotic and narcotic drugs (p<0.001 at t=1 and t=3, p<0.002 at t=6). The overall scores of quality of life improved significantly (p<0.05), with no difference in score between treatments. The subscores of mobility and energy of the NHP in non-amputated patients was significantly better in the SCS group (p<0.005). Amputation had a negative effect on mobility, resulting in a difficult rehabilitation but relieved pain substantially (p<0. 05). In contrast to the existing literature, the randomized trial revealed no major difference in overall pain and quality of life assessment between treatment groups. The effect on energy and mobility was significantly better in patients treated with SCS, who also used substantially fewer analgesics.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.044 | 0.043 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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; both teacher heads agree on what is shown here.
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".