Adverse events from spinal manipulation in the pregnant and postpartum periods: a critical review of the literature

<p>Abstract</p> <p>Background</p> <p>The safety of spinal manipulation during pregnancy and the postpartum periods has been a matter of debate among manual therapists. Spinal manipulative therapy during these periods is a commonly performed intervention as musculoskeletal pain is common in these patients. To date there has not been an evaluation of the literature on this topic exclusively.</p> <p>Methods</p> <p>A literature search was conducted on PubMed, CINAHL and the Index to Chiropractic Literature along with reference searching for articles published in English and French in the peer-reviewed literature that documented adverse effects of spinal manipulation during either pregnancy or postpartum. Case reports, case series, and any other clinical study designs were deemed acceptable for inclusion, as were systematic reviews. The appropriate Scottish Intercollegiate Guidelines Network (SIGN) tools were used to rate included articles for quality when applicable.</p> <p>Results</p> <p>Five articles identifying adverse events in seven subjects following spinal manipulation were included in this review, along with two systematic reviews. The articles were published between 1978 and 2009. Two articles describing adverse effects from spinal manipulation on two postpartum patients were included, while the remaining three articles on five patients with adverse effects following spinal manipulation were on pregnant patients. Injury severity ranged from minor injury such as increasing pain after treatment that resolved within a few days to more severe injuries including fracture, stroke, and epidural hematoma. SIGN scores of the prospective observational cohort study and systematic reviews indicated acceptable quality.</p> <p>Conclusions</p> <p>There are only a few reported cases of adverse events following spinal manipulation during pregnancy and the postpartum period identified in the literature. While improved reporting of such events is required in the future, it may be that such injuries are relatively rare.</p

Relative effectiveness and adverse effects of cervical manipulation, mobilisation and the activator instrument in patients with sub-acute non-specific neck pain: results from a stopped randomised trial

<p>Abstract</p> <p>Background</p> <p>Neck pain of a mechanical nature is a common complaint seen by practitioners of manual medicine, who use a multitude of methods to treat the condition. It is not known, however, if any of these methods are superior in treatment effectiveness. This trial was stopped due to poor recruitment. The purposes of this report are (1) to describe the trial protocol, (2) to report on the data obtained from subjects who completed the study, (3) to discuss the problems we encountered in conducting this study.</p> <p>Methods</p> <p>A pragmatic randomised clinical trial was undertaken. Patients who met eligibility criteria were randomised into three groups. One group was treated using specific segmental high velocity low amplitude manipulation (diversified), another by specific segmental mobilisation, and a third group by the Activator instrument. All three groups were also treated for any myofascial distortions and given appropriate exercises and advice. Participants were treated six times over a three-week period or until they reported being pain free. The primary outcome measure for the study was Patient Global Impression of Change (PGIC); secondary outcome measures included the Short-Form Health Survey (SF-36v₂), the neck Bournemouth Questionnaire, and the numerical rating scale for pain intensity. Participants also kept a diary of any pain medication taken and noted any perceived adverse effects of treatment. Outcomes were measured at four points: end of treatment, and 3, 6, and 12 months thereafter.</p> <p>Results</p> <p>Between January 2007 and March 2008, 123 patients were assessed for eligibility, of these 47 were considered eligible, of which 16 were allocated to manipulation, 16 to the Activator instrument and 15 to the mobilisation group. Comparison between the groups on the PGIC adjusted for baseline covariants did not show a significant difference for any of the endpoints. Within group analyses for change from baseline to the 12-month follow up for secondary outcomes were significant for all groups on the Bournemouth Questionnaire and for pain, while the mobilisation group had a significant improvement on the PCS and MCS subscales of the SF-36_v2. Finally, there were no moderate, severe, or long-lasting adverse effects reported by any participant in any group.</p> <p>Conclusions</p> <p>Although the small sample size must be taken into consideration, it appears that all three methods of treating mechanical neck pain had a long-term benefit for subacute neck pain, without moderate or serious adverse events associated with any of the treatment methods. There were difficulties in recruiting subjects to this trial. This pragmatic trial should be repeated with a larger sample size.</p

Are there efficacious treatments for treating the fatigue&ndash;sleep disturbance&ndash;depression symptom cluster in breast cancer patients? A Rapid Evidence Assessment of the Literature (REAL&copy;)

Shamini Jain,1 Courtney Boyd,2 Lavinia Fiorentino,1 Raheleh Khorsan,3 Cindy Crawford2 1Department of Psychiatry, University of California San Diego, San Diego, CA, USA; 2Samueli Institute, Alexandria, VA, USA; 3Samueli Institute, Corona Del Mar, CA, USA Purpose: While fatigue, sleep disturbance, and depression often co-occur in breast cancer patients, treatment efficacy for this symptom cluster is unknown. A systematic review was conducted to determine whether there are specific interventions (ie, medical, pharmacological, behavioral, psychological, and complementary medicine approaches) that are effective in mitigating the fatigue&ndash;sleep disturbance&ndash;depression symptom cluster in breast cancer patients, using the Rapid Evidence Assessment of the Literature (REAL&copy;) process. Methods: Peer-reviewed literature was searched across multiple databases; from database inception &ndash; October 2011, using keywords pre-identified to capture randomized controlled trials (RCT) relevant to the research question. Methodological bias was assessed using the Scottish Intercollegiate Guidelines Network (SIGN) 50 checklist. Confidence in the estimate of effect and assessment of safety were also evaluated across the categories of included interventions via the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology. Results: The initial search yielded 531 citations, of which 41 met the inclusion criteria. Of these, twelve RCTs reported on all three symptoms, and eight of these were able to be included in the GRADE analysis. The remaining 29 RCTs reported on two symptoms. Studies were of mixed quality and many were underpowered. Overall, results suggest that there is: 1) promising evidence for the effectiveness of various treatment types in mitigating sleep disturbance in breast cancer patients; 2) mixed evidence for fatigue; 3) little evidence for treating depression; and 4) no clear evidence that treatment of one symptom results in effective treatment for other symptoms. Conclusion: More high-quality studies are needed to determine the impact of varied treatments in mitigating the fatigue&ndash;sleep disturbance&ndash;depression symptom cluster in breast cancer patients. Furthermore, we encourage future studies to examine the psychometric and clinical validity of the hypothesized relationship between the symptoms in the fatigue&ndash;sleep disturbance&ndash;depression symptom cluster. Keywords: fatigue, sleep disturbance, depression, symptom cluster, breast cancer, Rapid Evidence Assessment of the Literatur

Patient-based outcome assessment instruments in acupuncture research.

BACKGROUND: Outcome assessment can support the therapeutic process by providing a way to track symptoms and functionality over time, providing insights to clinicians and patients, as well as offering a common language to discuss patient behavior/functioning. OBJECTIVES: In this article, we examine the patient-based outcome assessment (PBOA) instruments that have been used to determine outcomes in acupuncture clinical research and highlight measures that are feasible, practical, economical, reliable, valid, and responsive to clinical change. The aims of this review were to assess and identify the commonly available PBOA measures, describe a framework for identifying appropriate sets of measures, and address the challenges associated with these measures and acupuncture. Instruments were evaluated in terms of feasibility, practicality, economy, reliability, validity, and responsiveness to clinical change. METHODS: This study was a systematic review. A total of 582 abstracts were reviewed using PubMed (from inception through April 2009). RESULTS: A total of 582 citations were identified. After screening of title/abstract, 212 articles were excluded. From the remaining 370 citations, 258 manuscripts identified explicit PBOA; 112 abstracts did not include any PBOA. The five most common PBOA instruments identified were the Visual Analog Scale, Symptom Diary, Numerical Pain Rating Scales, SF-36, and depression scales such as the Beck Depression Inventory. CONCLUSIONS: The way a questionnaire or scale is administered can have an effect on the outcome. Also, developing and validating outcome measures can be costly and difficult. Therefore, reviewing the literature on existing measures before creating or modifying PBOA instruments can significantly reduce the burden of developing a new measure