Dataset Information

Timing of evidence-based non-surgical interventions as part of multimodal treatment guidelines for the management of cervical radiculopathy: a Delphi study protocol.

ABSTRACT:

Introduction

Cervical radiculopathy (CR) is a clinical condition whereby motor, reflex and/or sensory changes such as radicular pain, paraesthaesia or numbness can exist. Conservative management is a preferred first treatment option as the risk-benefit ratio for surgery is less favourable. Systematic reviews and treatment guidelines gather evidence on the effectiveness of non-surgical management of patients with CR from randomised controlled trials, which do not consider the natural course of recovery to modify the management strategy accordingly. The aim of this study is to establish consensus on effective non-surgical treatment modalities for patients in different stages (acute, subacute and chronic) of CR, using the Delphi method approach.

Methods and analysis

Through an iterative multistage process, experts within the field will rate their agreement with a list of proposed treatment modalities and suggest any missing treatment modalities during each round. Agreement will be measured using a five-point Likert scale. Descriptive statistics will be used to measure agreement (median, IQR and percentage of agreement). Consensus criteria will be defined a priori for each round. Data analysis at the end of round three will produce a consensus list of effective treatment modalities for the management of patients with CR in different stages of recovery.

Ethics and dissemination

Ethical approval has been granted from the University of Birmingham ethics committee under ERN_20-1121. The study findings will be submitted to a peer-reviewed journal and to relevant conferences for dissemination of the study results.

SUBMITTER: Thoomes E

PROVIDER: S-EPMC7970254 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundTraditionally paired meta-analysis revealed inconsistencies in the safety and effectiveness of surgical interventions. We conducted a network meta-analysis to assess various treatments' clinical efficacy and safety for pure cervical radiculopathy.MethodsThe Embase, PubMed, and Cochrane Library databases were searched for randomized controlled trials (RCTs) comparing different treatment options for patients with pure cervical radiculopathy from inception until October 23, 2021. The primary outcomes were postoperative success rates, postoperative complication rates, and postoperative reoperation rates. The pooled data were subjected to a random-effects consistency model. The protocol was published in PROSPERO (CRD42021284819).ResultsThis study included 23 RCTs (n = 1,844) that evaluated various treatments for patients with pure cervical radiculopathy. There were no statistical differences between treatments in the consistency model in terms of major clinical effectiveness and safety outcomes. Postoperative success rates were higher for anterior cervical foraminotomy (ACF: probability 38%), posterior cervical foraminotomy (PCF: 24%), and anterior cervical discectomy with fusion and additional plating (ACDFP: 21%). Postoperative complication rates ranked from high to low as follows: cervical disc replacement (CDR: probability 32%), physiotherapy (25%), ACF (25%). Autologous bone graft (ABG) had better relief from arm pain (probability 71%) and neck disability (71%). Among the seven surgical interventions with a statistical difference, anterior cervical discectomy with allograft bone graft plus plating (ABGP) had the shortest surgery time.ConclusionsAccording to current results, all surgical interventions can achieve satisfactory results, and there are no statistically significant differences. As a result, based on their strengths and patient-related factors, surgeons can exercise discretion in determining the appropriate surgical intervention for pure cervical radiculopathy.Systematic Review Registration: CRD42021284819.

Project description:BACKGROUND:A research gap exists for optimal management of cervical radiculopathy in the first 12?weeks and short term natural history of the condition is somewhat unclear, although thought to be favourable. The primary aim of this assessor blinded, superiority, 2 parallel group randomised controlled trial is to investigate the effects of a 4?week physiotherapy programme (6-8 sessions) of manual therapy, exercise and upper limb neural unloading tape, compared to a control of weekly phone advice; on disability, pain and selected biopsychosocial measures, in acute and sub-acute cervical radiculopathy patients. A secondary aim is to identify whether any baseline variables, symptom duration or group allocation can predict outcome. METHODS:Participants are recruited from GP referrals in an urban setting, from a neurosurgery non-urgent waiting list and from self-referral through Facebook advertising. Eligible participants (n =?64) are diagnosed with radiculopathy based on a clinical prediction rule and must have symptoms of unilateral, single level, radiculopathy for between 2 and 12?weeks, without having yet received physiotherapy. Random 1:1 group allocation (using variable block sizes), allocation concealment, blinded assessment and intention to treat analysis are being employed. Treatment is provided by clinical specialist physiotherapists in primary and secondary care settings. Outcomes are measured at baseline, 4 (primary endpoint) and 12?weeks. Participants' report of pain, disability and their rating of recovery is also recorded by telephone interview at 6?months. Statistical analysis of between group differences will be performed with ANOVAs and MANOVAs, and multivariable regression analysis will be undertaken to explore predictor variables. Ethical approval for this study has been received from the Beaumont Hospital and Irish College of General Practitioners Research Ethics Committees. The trial is registered at ClinicalTrials.gov (NCT02449200). DISCUSSION:An internal pilot study to test retention and recruitment strategies led to trial expansion and this is now a multi centre trial involving 5 clinical sites. TRIAL REGISTRATION:NCT02449200 . Registered 20/05/15.