Trial reportHeart (British Cardiac Society)2007
Thoracic spinal cord stimulation improves functional status and relieves symptoms in patients with refractory angina pectoris: the first placebo-controlled randomised study.
Trial report in Heart (British Cardiac Society), 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers, 5 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
40 citing papers in PubMed, 5 syntheses or guidelines pooled it, 166 citations in OpenAlex.
- A Pragmatic Review on Spinal Cord Stimulation Therapy for Parkinson's Disease Gait Related Disorders: Gaps and Controversies.Movement disorders clinical practice · 2024Pooled it
- Randomized Placebo-/Sham-Controlled Trials of Spinal Cord Stimulation: A Systematic Review and Methodological Appraisal.Neuromodulation : journal of the International Neuromodulation Society · 2020Pooled it
- Spinal Cord Stimulation for Refractory Angina Pectoris: A Systematic Review and Meta-analysis.The Clinical journal of pain · 2017Pooled it
- [Epidural spinal cord stimulation for therapy of chronic pain. Summary of the S3 guidelines].Schmerz (Berlin, Germany) · 2011Guideline
- Spinal cord stimulation in the treatment of refractory angina: systematic review and meta-analysis of randomised controlled trials.BMC cardiovascular disorders · 2009Pooled it
- Trial
- The Effectiveness and Cost-Effectiveness of Spinal Cord Stimulation for Refractory Angina (RASCAL Study): A Pilot Randomized Controlled Trial.Neuromodulation : journal of the International Neuromodulation Society · 2016Trial
- Spinal cord stimulation is safe and feasible in patients with advanced heart failure: early clinical experience.European journal of heart failure · 2014Trial
- Stimulation of the sphenopalatine ganglion (SPG) for cluster headache treatment. Pathway CH-1: a randomized, sham-controlled study.Cephalalgia : an international journal of headache · 2013Trial
- Contemporary and Emerging Therapies in the Management of Refractory Angina: A Clinical Review.Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions · 2026Review
- Brain‑heart axis: Neurostimulation techniques in ischemic heart disease (Review).International journal of molecular medicine · 2025Review
- Prospective evaluation of spinal cord stimulation in refractory angina: insights from a single-center cohort.Frontiers in cardiovascular medicine · 2025Article
- Problems With O'Connell et al, "Implanted Spinal Neuromodulation Interventions for Chronic Pain in Adults" (Cochrane Review).Neuromodulation : journal of the International Neuromodulation Society · 2023Article
- Design and rationale of the efficacy of spinal cord stimulation in patients with refractory angina pectoris (SCRAP) trial.Clinical cardiology · 2023Article
- Long-term efficacy and safety of spinal cord stimulation in patients with refractory angina pectoris.International journal of cardiology. Heart & vasculature · 2023Article
- Refractory angina pectoris: a 20-year (2003-2022) bibliometric analysis.Frontiers in cardiovascular medicine · 2023Article
- Neuromodulation in patients with refractory angina pectoris: a review.European heart journal open · 2023Review
- Device-based neuromodulation for cardiovascular diseases and patient' s age.Journal of geriatric cardiology : JGC · 2022Article
- Improvement in quality of life and angina pectoris: 1-year follow-up of patients with refractory angina pectoris and spinal cord stimulation.Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation · 2020Article
- Non-pharmacological Treatment of Refractory Angina and Microvascular Angina.Biomedicines · 2020Review
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSpinal cord stimulation (SCS) is an alternative treatment option for refractory angina. Controlled trials demonstrate symptom relief and improvement in functional status. Since patients experience retrosternal prickling during active SCS, there is no option for blinding patients to active treatment or for placebo control.
objectiveTo examine the therapeutic effects of subthreshold SCS in patients with refractory angina in a placebo-controlled study.
methods12 responders to treatment who had already been treated with SCS for refractory angina were enrolled. Patients were randomised into four consecutive treatment arms, each for 4 weeks, with various stimulation timing and output parameters: 3 x 2 h/day (phase A) and 24 h/day with conventional output (phase B); 3 x 2 h/day with a subthreshold output (phase C); and 24 h/day with 0.1 V output, which served as control (phase D). Functional status, quality of life, Canadian Cardiovascular Society classification and nitrate usage were assessed at the end of each 4-week period.
resultsIn phase D, patients showed a significant reduction in walking distance compared with phases A and C. Canadian Cardiovascular Society classification worsened in phase D compared with phases A-C. Frequency of angina attacks and the visual analogue scale were significantly worse in phase D than in phases A-C. In three patients, it was necessary to prematurely terminate phase D owing to intolerable angina attacks.
conclusionsIn this first placebo-controlled trial to apply SCS in patients with refractory angina, improvement in functional status and symptoms was revealed in phases with conventional or subthreshold stimulation, in comparison to a low-output (placebo) phase.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.