Defining adverse events in manual therapies: A modified Delphi consensus study

Carnes, Dawn; Mullinger, Brenda; Underwood, Martin

doi:10.1016/j.math.2009.02.003

Cited by 94 publications

(67 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…We defined an adverse event as sequelae medium-to long-term in duration, with moderate to severe symptoms that were serious, distressing, and unacceptable to the patient and required further treatment. 9 Some patients did report minor side effects, which were defined as short term, mild in nature, nonserious, transient, and were reversible consequences of the treatment, such as an increase in neck pain, headache, and fatigue. 37 These posttreatment side effects were reported to disappear within 24 to 48 hours.…”

Section: Treatment Side Effectsmentioning

confidence: 99%

Thoracic Spine Thrust Manipulation Versus Cervical Spine Thrust Manipulation in Patients With Acute Neck Pain : A Randomized Clinical Trial

Puentedura¹,

Landers²,

Cleland³

et al. 2011

Journal of Orthopaedic & Sports Physical Therapy

116

View full text Add to dashboard Cite

Study Design Randomized clinical trial. Objective To determine if patients who met the clinical prediction rule (CPR) criteria for the success of thoracic spine thrust joint manipulation (TJM) for the treatment of neck pain would have a different outcome if they were treated with a cervical spine TJM. Background A CPR had been proposed to identify patients with neck pain who would likely respond favorably to thoracic spine TJM. Research on validation of that CPR had not been completed when this trial was initiated. In our clinical experience, though many patients with neck pain responded favorably to thoracic spine TJM, they often reported that their symptomatic cervical spine area had not been adequately addressed. Methods Twenty-four consecutive patients, who presented to physical therapy with a primary complaint of neck pain and met 4 out of 6 of the CPR criteria for thoracic TJM, were randomly assigned to 1 of 2 treatment groups. The thoracic group received thoracic TJM and a cervical range-of-motion (ROM) exercise for the first 2 sessions, followed by a standardized exercise program for an additional 3 sessions. The cervical group received cervical TJM and the same cervical ROM exercise for the first 2 sessions, and the same exercise program given to the thoracic group for the next 3 sessions. Outcome measures collected at 1 week, 4 weeks, and 6 months from start of treatment included the Neck Disability Index, numeric pain rating scale, and Fear-Avoidance Beliefs Questionnaire. Results Patients who received cervical TJM demonstrated greater improvements in Neck Disability Index (P≤.001) and numeric pain rating scale (P≤.003) scores at all follow-up times. There was also a statistically significant improvement in the Fear-Avoidance Beliefs Questionnaire physical activity subscale score at all follow-up times for the cervical group (P≤.004). The number needed to treat to avoid an unsuccessful overall outcome was 1.8 at 1 week, 1.6 at 4 weeks, and 1.6 at 6 months. Conclusion Patients with neck pain who met 4 of 6 of the CPR criteria for successful treatment of neck pain with a thoracic spine TJM demonstrated a more favorable response when the TJM was directed to the cervical spine rather than the thoracic spine. Patients receiving cervical TJM also demonstrated fewer transient side-effects. Level of Evidence Therapy, level 1b. J Orthop Sports Phys Ther 2011;41(4):208–220, Epub 18 February 2011. doi:10.2519/jospt.2011.3640

show abstract

Section: Treatment Side Effectsmentioning

confidence: 99%

Thoracic Spine Thrust Manipulation Versus Cervical Spine Thrust Manipulation in Patients With Acute Neck Pain : A Randomized Clinical Trial

Puentedura¹,

Landers²,

Cleland³

et al. 2011

Journal of Orthopaedic & Sports Physical Therapy

116

View full text Add to dashboard Cite

show abstract

“…33 It is clear that the adverse events reported were transient and would likely be considered mild to moderate in nature according to the existing evidence in this area. 10,11 In the absence of a de facto framework for defining categories of adverse events in manual therapy, however, we cannot state this confidently.…”

Section: Generalizabilitymentioning

confidence: 99%

“…9,10 The published studies reporting estimates of adverse events cannot be compared to one another, since they typically report events using non-standardized definitions of mild, moderate, and serious events. Carnes and colleagues 10 proposed a framework for categorizing and defining adverse events; Carlesso and colleagues 11 and Rajendran and colleagues 12 have since added to this evidence by providing the perspective of patients, a viewpoint not included in the initial framework. In combination, these studies provide a solid foundation from which to begin more standardized classification and definition of adverse events in manual therapies.…”

mentioning

confidence: 99%

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

Carlesso¹,

MacDermid

Santaguida³

et al. 2013

Physiotherapy Canada

View full text Add to dashboard Cite

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...

show abstract

“…the Patient PerSPeCtive t he one notable oversight in the Carnes study 9 was the exclusion of patients in the consensus exercise. Previous studies have indicated that patients have a different view of complications than clinicians, 51 specifically for acute injuries like distal radius fracture.…”

Section: Adverse Event/adverse Experiencementioning

confidence: 99%

“…Until now, orthopaedic physical therapists have been functioning without any standard terminology or definitions of types and severity of adverse events. Carnes et al 9 have provided a framework from which the process of standardization can begin. They provide a hierarchical system (Figure) to help define and categorize the range of possible adverse events.…”

mentioning

confidence: 99%

Standardization of Adverse Event Terminology and Reporting in Orthopaedic Physical Therapy: Application to the Cervical Spine

Carlesso¹,

MacDermid²,

Santaguida³

2010

J Orthop Sports Phys Ther

View full text Add to dashboard Cite

Defining adverse events in manual therapies: A modified Delphi consensus study

Cited by 94 publications

References 12 publications

Thoracic Spine Thrust Manipulation Versus Cervical Spine Thrust Manipulation in Patients With Acute Neck Pain : A Randomized Clinical Trial

Thoracic Spine Thrust Manipulation Versus Cervical Spine Thrust Manipulation in Patients With Acute Neck Pain : A Randomized Clinical Trial

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

Standardization of Adverse Event Terminology and Reporting in Orthopaedic Physical Therapy: Application to the Cervical Spine

Contact Info

Product

Resources

About