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

Carnes, Dawn; Mullinger, Brenda; Underwood, Martin

doi:10.1016/j.ijosm.2010.03.001

Cited by 25 publications

(44 citation statements)

References 9 publications

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“…There were no major or moderate AEs 42,43 reported following the administration of 131 ST and 272 SM interventions. Two mild AEs were reported by participants in the STzPR group.…”

Section: Engel Et Al Mt In Pulmonary Rehabilitation Program For Copdmentioning

confidence: 93%

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Medium term effects of including manual therapy in a pulmonary rehabilitation program for chronic obstructive pulmonary disease (COPD): a randomized controlled pilot trial.

Engel¹,

Gonski

Beath

et al. 2016

Journal of Manual & Manipulative Therapy

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Study design: Randomized clinical trial. Objective: To investigate the effect of including manual therapy (MT) in a pulmonary rehabilitation program for patients with chronic obstructive pulmonary disease (COPD). Background: The primary source of exercise limitation in people with COPD is dyspnea. The dyspnea is partly caused by changes in chest wall mechanics, with an increase in chest wall rigidity (CWR) contributing to a decrease in lung function. As MT is known to increase joint mobility, administering MT to people with COPD carries with it the potential to influence CWR and lung function. Methods: Thirty-three participants with COPD, aged between 55 and 70 years (mean565.5¡4 years), were randomly assigned to three groups: pulmonary rehabilitation (PR) only, soft tissue therapy (ST) and PR, and ST, spinal manipulative therapy (SM), and PR. Outcome measures including forced expiratory volume in the 1st second (FEV 1 ), forced vital capacity (FVC), 6-minute walking test (6MWT), St. George's respiratory questionnaire (SGRQ), and the hospital anxiety and depression (HAD) scale were recorded at 0, 8, 16, and 24 weeks. Results: There was a significant difference in FVC between the three groups at 24 weeks (P50.04). For the STzSMzPR group versus PR only the increase was 0.40 l (CI: 0.02, 0.79; P50.03). No major or moderate adverse events (AE) were reported following the administration of 131 ST and 272 SM interventions. Discussion: The increase in FVC is a unique finding. Although the underlying mechanisms responsible for this outcome are not yet understood, the most likely explanation is the synergistic effect resulting from the combination of interventions. These results support the call for a larger clinical trial in the use of MT for COPD.

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“…There were no major or moderate AEs 42,43 reported following the administration of 131 ST and 272 SM interventions. Two mild AEs were reported by participants in the STzPR group.…”

Section: Engel Et Al Mt In Pulmonary Rehabilitation Program For Copdmentioning

confidence: 93%

“…42,43 A 'mild' AE is defined as being short-term and nonserious with the patient's function remaining intact; a 'moderate' AE is medium to long term of moderate intensity; while a 'severe' AE is medium to long term, unacceptable and usually requiring further treatment. The presence of an AE was recorded on a session by session basis.…”

Section: Methodsmentioning

confidence: 99%

Medium term effects of including manual therapy in a pulmonary rehabilitation program for chronic obstructive pulmonary disease (COPD): a randomized controlled pilot trial.

Engel¹,

Gonski

Beath

et al. 2016

Journal of Manual & Manipulative Therapy

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“…The definitions for 'significant' and 'mild' events were adapted from those proposed by Carnes et al 34 In the current study, a 'mild' AE was defined as short-term and non-serious, with no change in function, whereas the term, 'significant', was chosen to represent moderate or major AEs, described by Carnes et al 34 as medium to long-term events that are serious, distressing and may require further treatment. In the study by Carnes et al, 34 specific time frames were not included in the final definitions of mild, moderate, or major AEs. However, the general consensus (.74%) was that mild AEs lasted hours, moderate AEs lasted days and major AEs lasted weeks.…”

Section: Methods Definitionmentioning

confidence: 99%

Adverse events following trigger point dry needling: a prospective survey of chartered physiotherapists

Brady

McEvoy

Dommerholt

et al. 2013

Journal of Manual & Manipulative Therapy

135

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“…2 An AE is here defined as the sequelae following a CSM that are medium to long term in duration, with moderate to severe symptoms, and of a nature that was serious, distressing, and unacceptable to the patient and required further treatment. 3,4 Much of the debate regarding the safety of CSM may be attributed to the lack of agreement between incidence reports of AE following CSM, which have been reported to vary from 1/50 000 to 1/5.85 million manipulations. 5,6 While there is little agreement between the frequency of incidence, it is evident that there are some risks associated with CSM.…”

Section: Introductionmentioning

confidence: 99%

Safety of cervical spine manipulation: are adverse events preventable and are manipulations being performed appropriately? A review of 134 case reports

Puentedura

March

Anders

et al. 2012

Journal of Manual & Manipulative Therapy

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Background: Cervical spine manipulation (CSM) is a commonly utilized intervention, but its use remains controversial.Purpose: To retrospectively analyze all available documented case reports in the literature describing patients who had experienced severe adverse events (AEs) after receiving CSM to determine if the CSM was used appropriately, and if these types of AEs could have been prevented using sound clinical reasoning on the part of the clinician. Data sources: PubMed and the Cumulative Index to Nursing and Allied Health were systematically searched for case reports between 1950 and 2010 of AEs following CSM. Study selection: Case reports were included if they were peer-reviewed; published between 1950 and 2010; case reports or case series; and had CSM as an intervention. Articles were excluded if the AE occurred without CSM (e.g. spontaneous); they were systematic or literature reviews. Data extracted from each case report included: gender; age; who performed the CSM and why; presence of contraindications; the number of manipulation interventions performed; initial symptoms experienced after the CSM; and type of resultant AE. Data synthesis: Based on the information gathered, CSMs were categorized as appropriate or inappropriate, and AEs were categorized as preventable, unpreventable, or unknown. Chi-square analysis with an alpha level of 0.05 was used to determine if there was a difference in proportion between six categories: appropriate/preventable, appropriate/unpreventable, appropriate/unknown, inappropriate/ preventable, inappropriate/unpreventable, and inappropriate/unknown. Results: One hundred thirty four cases, reported in 93 case reports, were reviewed. There was no significant difference in proportions between appropriateness and preventability, P5.46. Of the 134 cases, 60 (44.8%) were categorized as preventable, 14 (10.4%) were unpreventable and 60 (44.8%) were categorized as 'unknown'. CSM was performed appropriately in 80.6% of cases. Death resulted in 5.2% (n57) of the cases, mostly caused by arterial dissection. Limitations: There may have been discrepancies between what was reported in the cases and what actually occurred, since physicians dealing with the effects of the AE, rather than the clinician performing the CSM, published many of the cases. Conclusions: This review showed that, if all contraindications and red flags were ruled out, there was potential for a clinician to prevent 44.8% of AEs associated with CSM. Additionally, 10.4% of the events were unpreventable, suggesting some inherent risk associated with CSM even after a thorough exam and proper clinical reasoning.

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

Cited by 25 publications

References 9 publications

Medium term effects of including manual therapy in a pulmonary rehabilitation program for chronic obstructive pulmonary disease (COPD): a randomized controlled pilot trial.

Medium term effects of including manual therapy in a pulmonary rehabilitation program for chronic obstructive pulmonary disease (COPD): a randomized controlled pilot trial.

Adverse events following trigger point dry needling: a prospective survey of chartered physiotherapists

Safety of cervical spine manipulation: are adverse events preventable and are manipulations being performed appropriately? A review of 134 case reports

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