{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,4]],"date-time":"2026-09-04T05:56:28Z","timestamp":1788501388394,"version":"build-2803163510"},"reference-count":131,"publisher":"National Institute for Health and Care Research","license":[{"start":{"date-parts":[[2023,10,1]],"date-time":"2023-10-01T00:00:00Z","timestamp":1696118400000},"content-version":"unspecified","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["16\/31\/53"],"award-info":[{"award-number":["16\/31\/53"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"Background<\/jats:title>\nPosterior cervical foraminotomy and anterior cervical discectomy are routinely used operations to treat cervical brachialgia, although definitive evidence supporting superiority of either is lacking.<\/jats:p>\n<\/jats:sec>\nObjective<\/jats:title>\nThe primary objective was to investigate whether or not posterior cervical foraminotomy is superior to anterior cervical discectomy in improving clinical outcome.<\/jats:p>\n<\/jats:sec>\nDesign<\/jats:title>\nThis was a Phase III, unblinded, prospective, United Kingdom multicentre, parallel-group, individually randomised controlled superiority trial comparing posterior cervical foraminotomy with anterior cervical discectomy. A rapid qualitative study was conducted during the close-down phase, involving remote semistructured interviews with trial participants and health-care professionals.<\/jats:p>\n<\/jats:sec>\nSetting<\/jats:title>\nNational Health Service trusts.<\/jats:p>\n<\/jats:sec>\nParticipants<\/jats:title>\nPatients with symptomatic unilateral cervical brachialgia for at least 6 weeks.<\/jats:p>\n<\/jats:sec>\nInterventions<\/jats:title>\nParticipants were randomised to receive posterior cervical foraminotomy or anterior cervical discectomy. Allocation was not blinded to participants, medical staff or trial staff. Health-care use from providing the initial surgical intervention to hospital discharge was measured and valued using national cost data.<\/jats:p>\n<\/jats:sec>\nMain outcome measures<\/jats:title>\nThe primary outcome measure was clinical outcome, as measured by patient-reported Neck Disability Index score 52 weeks post operation. Secondary outcome measures included complications, reoperations and restricted American Spinal Injury Association score over 6 weeks post operation, and patient-reported Eating Assessment Tool-10 items, Glasgow\u2013Edinburgh Throat Scale, Voice Handicap Index-10 items, PainDETECT and Numerical Rating Scales for neck and upper-limb pain over 52 weeks post operation.<\/jats:p>\n<\/jats:sec>\nResults<\/jats:title>\nThe target recruitment was 252 participants. Owing to slow accrual, the trial closed after randomising 23 participants from 11 hospitals. The qualitative substudy found that there was support and enthusiasm for the posterior cervical FORaminotomy Versus Anterior cervical Discectomy in the treatment of cervical brachialgia trial and randomised clinical trials in this area. However, clinical equipoise appears to have been an issue for sites and individual surgeons. Randomisation on the day of surgery and processes for screening and approaching participants were also crucial factors in some centres. The median Neck Disability Index scores at baseline (pre surgery) and at 52 weeks was 44.0 (interquartile range 36.0\u201362.0 weeks) and 25.3 weeks (interquartile range 20.0\u201342.0 weeks), respectively, in the posterior cervical foraminotomy group (n<\/jats:italic> = 14), and 35.6 weeks (interquartile range 34.0\u201344.0 weeks) and 45.0 weeks (interquartile range 20.0\u201357.0 weeks), respectively, in the anterior cervical discectomy group (n<\/jats:italic> = 9). Scores appeared to reduce (i.e. improve) in the posterior cervical foraminotomy group, but not in the anterior cervical discectomy group. The median Eating Assessment Tool-10 items score for swallowing was higher (worse) after anterior cervical discectomy (13.5) than after posterior cervical foraminotomy (0) on day 1, but not at other time points, whereas the median Glasgow\u2013Edinburgh Throat Scale score for globus was higher (worse) after anterior cervical discectomy (15, 7, 6, 6, 2, 2.5) than after posterior cervical foraminotomy (3, 0, 0, 0.5, 0, 0) at all postoperative time points. Five postoperative complications occurred within 6 weeks of surgery, all after anterior cervical discectomy. Neck pain was more severe on day 1 following posterior cervical foraminotomy (Numerical Rating Scale \u2013 Neck Pain score 8.5) than at the same time point after anterior cervical discectomy (Numerical Rating Scale \u2013 Neck Pain score 7.0). The median health-care costs of providing initial surgical intervention were \u00a32610 for posterior cervical foraminotomy and \u00a34411 for anterior cervical discectomy.<\/jats:p>\n<\/jats:sec>\nConclusions<\/jats:title>\nThe data suggest that posterior cervical foraminotomy is associated with better outcomes, fewer complications and lower costs, but the trial recruited slowly and closed early. Consequently, the trial is underpowered and definitive conclusions cannot be drawn. Recruitment was impaired by lack of individual equipoise and by concern about randomising on the day of surgery. A large prospective multicentre trial comparing anterior cervical discectomy and posterior cervical foraminotomy in the treatment of cervical brachialgia is still required.<\/jats:p>\n<\/jats:sec>\nTrial registration<\/jats:title>\nThis trial is registered as ISRCTN10133661.<\/jats:p>\n<\/jats:sec>\nFunding<\/jats:title>\nThis project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment<\/jats:italic>; Vol. 27, No. 21. See the NIHR Journals Library website for further project information.<\/jats:p>\n<\/jats:sec>","DOI":"10.3310\/otoh7720","type":"journal-article","created":{"date-parts":[[2023,11,6]],"date-time":"2023-11-06T09:11:50Z","timestamp":1699261910000},"page":"1-228","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":6,"title":["Posterior cervical foraminotomy versus anterior cervical discectomy for Cervical Brachialgia: the FORVAD RCT"],"prefix":"10.3310","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4827-1961","authenticated-orcid":true,"given":"Simon","family":"Thomson","sequence":"first","affiliation":[{"name":"Department of Neurosurgery, Leeds Teaching Hospitals NHS Trust, Leeds, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9952-8440","authenticated-orcid":true,"given":"Gemma","family":"Ainsworth","sequence":"additional","affiliation":[{"name":"Clinical Trials Research 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