Determining Adverse Events in Patients with Neck Pain Receiving Orthopaedic Manual Physiotherapy: A Pilot and Feasibility Study

Abstract

Purpose: To pilot and determine the feasibility of estimating adverse events in patients with neck pain treated with cervical manipulation/mobilization by Canadian orthopaedic manual physiotherapists (OMPTs) using an online data-collection system to provide estimates for a future larger multi-centre international study. Methods: In a prospective multi-site two-group cohort study, participants received usual care and either (a) combined manipulation and mobilization or (b) mobilization only. Study feasibility objectives and criteria for success were set a priori. Data were analyzed using descriptive statistics. Results: A total of 20 patients were recruited from 6 of 16 participating centres, 17 to the mobilization group and 3 to the combined group. Barriers to data collection included low recruitment, difficulties in using the online data-collection system, and clinicians' and patients' being too busy to participate. Missing data for the primary outcome averaged 28.5%. A total of 69 symptom occurrences were reported during the treatment phase, all benign and transient. Most began within 0-12 hours after treatment (66/69, 95.6%) and lasted for 0-2 days (56/69, 81.2%). Kappa estimates of agreement between therapists and patients on reporting of adverse symptoms across visits 1-5 was substantial (k ¼ 0.68; 95% CI, 0.52-0.84; p < 0.01). Conclusions: This pilot study demonstrates substantial challenges in conducting a large multi-centre trial. Brief, benign, and transient adverse events were common; no substantial adverse events were observed.Key Words: adverse events; feasibility study; neck manipulation; pilot study. RÉ SUMÉObjectif : Dé terminer, dans le cadre d'un projet pilote, s'il est possible d'estimer les é vé nements indé sirables chez les patients dont la douleur au cou est traité e par manipulation/mobilisation cervicale effectué e par des physiothé rapeutes manuels orthopé diques (PTMO) du Canada en utilisant un systè me de collecte des donné es en ligne pour produire des estimations en vue d'une future é tude internationale multicentrique de plus grande envergure. Mé thodes : On a procé dé à une é tude de cohorte prospective à deux groupes multisites; les participants ont reç u les soins habituels et a) une manipulation et une mobilisation combiné es ou b) une mobilisation seulement. Les objectifs relatifs à la faisabilité de l'é tude et les critè res de ré ussite ont é té é tablis d'avance. On a utilisé des statistiques descriptives. Ré sultats : Vingt patients ont é té recruté s de six centres participants sur 16, soit 17 dans le groupe qui a subi une mobilisation et trois dans celui qui a subi le traitement combiné . Les obstacles à la collecte des donné es ont inclus l'effectif peu nombreux recruté , la difficulté à utiliser le systè me de collecte de donné es en ligne et le fait que les cliniciens et les patients é taient trop occupé s pour participer. Les donné es manquantes pour le ré sultat primaire se sont é tablies en moyenne à 28,5%. Au total, on a signalé 69 occurrences de symptô mes...

Efficacy and Safety of Shi Cervical Rotational Manipulation in Patients With Atlantoaxial Joint Subluxation: Protocol for a Randomized Controlled Trial (Preprint)

“…Conversely, the axis serves as the focal point for stress in the upper cervical spine and functions as a primary attachment site for the neck's short muscles and ligaments [5]. In instances where the atlantoaxial joint experiences a pathological state known as "Joint Subluxation," it can lead to the entrapment of the synovial membrane and joint capsule, resulting in localized swelling and pain in the cervical spine, impaired joint movement, and stimulation of the corresponding regions of the nerves, blood vessels, and receptors, which will cause symptoms such as vertigo and pain [6]. For a long time, the AJS has been commonly referred to as atlantoaxial joint instability, atlantoaxial joint disorder and so on [7,8].…”

Patient Safety in Physiotherapy: Are Errors that Cause or Could Cause Harm Preventable?

“…• Faulty material that results in a patient falling and is not reported • False reporting of data and cover-up of a colleague • Substandard care and fraud whereby a practitioner records treating a patient seen by another practitioner due to staff shortages Other authors in the field have analyzed AEs, risk factors, and effects associated with different types of physiotherapy techniques, modalities, and situations, such as dry needling [45], manual therapy [46][47][48][49][50][51], hospital falls, and early mobilization in orthopedic [30,32,52] and/or intensive care patients [31].…”

Compensation claims for chiropractic in Denmark and Norway 2004¿2012

“…Accurate information on harms is imperative for evidence-based practice and as such AE should be reported from all parts of medicine [4]. Within musculoskeletal care, a plethora of AE have been published with regards to spine surgery [5], hip and knee surgery [6][7][8][9], corticosteroid injections [10,11], pharmacological therapy [12] exercise and physiotherapy [13][14][15] and manual therapy (MT) [16,17].…”