Jennifer E. Bolton

Safety of chiropractic manipulation of the cervical spine: a prospective national survey

Study Design. Prospective national survey. Objective. To estimate the risk of serious and relatively minor adverse events following chiropractic manipulation of the cervical spine by a sample of U.K. chiropractors. Summary of Background Data. The risk of a serious adverse event following chiropractic manipulation of the cervical spine is largely unknown. Estimates range from 1 in 200,000 to 1 in several million cervical spine manipulations. Methods. We studied treatment outcomes obtained from 19,722 patients. Manipulation was defined as the application of a high-velocity/low-amplitude or mechanically assisted thrust to the cervical spine. Serious adverse events, defined as “referred to hospital A&E and/or severe onset/worsening of symptoms immediately after treatment and/or resulted in persistent or significant disability/incapacity,” and minor adverse events reported by patients as a worsening of presenting symptoms or onset of new symptoms, were recorded immediately, and up to 7 days, after treatment. Results. Data were obtained from 28,807 treatment consultations and 50,276 cervical spine manipulations. There were no reports of serious adverse events. This translates to an estimated risk of a serious adverse event of, at worse ≈1 per 10,000 treatment consultations immediately after cervical spine manipulation, ≈2 per 10,000 treatment consultations up to 7 days after treatment and ≈6 per 100,000 cervical spine manipulations. Minor side effects with a possible neurologic involvement were more common. The highest risk immediately after treatment was fainting/dizziness/light-headedness in, at worse ≈16 per 1000 treatment consultations. Up to 7 days after treatment, these risks were headache in, at worse ≈4 per 100, numbness/tingling in upper limbs in, at worse ≈15 per 1000 and fainting/dizziness/light-headedness in, at worse ≈13 per 1000 treatment consultations. Conclusion. Although minor side effects following cervical spine manipulation were relatively common, the risk of a serious adverse event, immediately or up to 7 days after treatment, was low to very low.

A cross-sectional study correlating lumbar spine degeneration with disability and pain.

Study Design. Cross-sectional design. Objectives. To investigate the correlation between degeneration in the lumbar spine and self-reported disability and pain levels in patients with and without a history of trauma. Summary of Background Data. The link between lumbar spine degeneration and low back pain remains controversial, as does the correlation between trauma and spinal degeneration. Methods. Radiographic and questionnaire data were collected from 172 consecutive patients with low back pain. Back pain severity was measured using two scales: one for pain over the entire episode and one for pain during the previous week. All patients also completed the Revised Oswestry Disability Questionnaire before radiography was performed. Further questions concerning the chronicity of symptoms and trauma were included. Results. Controlling for age, patients with low back pain with a history of trauma had a statistically significant increase in the severity of facet degeneration (P < 0.02) compared with nontrauma patients with low back pain. However, there was no difference in disability and pain scores between the trauma and nontrauma patients or between the genders. A weak correlation between pain severity ratings and the number of levels of degeneration and the severity of the degeneration at the disc and facets was noted. Conclusions. Patients with low back pain with a history of trauma had more severe facet arthrosis than do nontrauma patients with low back pain, but there were no differences in pain and disability. There was a weak correlation between the quantity and severity of lumbar degeneration with pain levels, but not with disability scores. These findings are discussed in the light of recent reports regarding the cervical spine.

Sensitivity and specificity of outcome measures in patients with neck pain: detecting clinically significant improvement.

Study Design. Prospective, single-cohort study. Objective. To determine the relative sensitivity of a range of outcome measures used in evaluating treatment interventions in patients with neck pain and the magnitude of change scores on the neck Bournemouth Questionnaire and the cutoff score on the Patients’ Global Impression of Change scale associated with clinically significant improvement. Summary of Background Data. Traditionally, evaluation of treatment interventions using subjective outcome measures has been based on the statistical significance of the difference between group mean values. To be clinically meaningful, however, information is required from sensitive outcome measures on the proportion of patients undergoing a clinically important improvement and from this, the number needed to treat for a single patient to benefit. Methods. Patients with nonspecific neck pain from a number of treatment centers completed a battery of self-report questionnaires, including the Bournemouth Questionnaire, before and after chiropractic treatment. After treatment, patients also completed a retrospective analysis of their overall improvement since the start of treatment (Patients’ Global Impression of Change). The a priori definition of clinically significant improvement was defined as a Reliable Change Index on the Bournemouth Questionnaire of >1.96. Results. The best cutoffs with a balance between the highest sensitivity and highest specificity in detecting clinical improvement were a score of 2 or less on the Patients’ Global Impression of Change (11-point Numerical Rating Scale: 0 = much better, 5 = no change, and 10 = much worse) and a raw change score of three or more points on each of the seven 11-point Numerical Rating Scale subscales of the Bournemouth Questionnaire. For the total score of the Bournemouth Questionnaire, raw change scores of 13 or more points, percentage change scores of 36% or more, and individual effect sizes of 1.0 or more were all associated with clinically significant improvement. The sensitivity of the Bournemouth Questionnaire in terms of its effect size was comparable with that of pain intensity scales and the Neck Disability Index. Conclusions. The present findings will assist in the choice of outcome measures in trials on neck pain. The study also illustrates a methodologic framework for interpreting change scores in terms of clinical improvement, facilitating the process of making sense of research data in the clinical setting.

Responsiveness of the Bournemouth Questionnaire in Determining Minimal Clinically Important Change in Subgroups of Low Back Pain Patients

Study Design. Prospective single cohort. Objective. To determine the ability of the Bournemouth Questionnaire (BQ) to distinguish between improved and nonimproved patients who present with either short (acute) or long (subacute/chronic) duration low back pain (LBP), and with either high or low baseline scores (severity). Summary of Background Data. Recent evidence suggests that the responsiveness of outcome measures used to determine clinical change is dependent on the chronicity and severity of the condition. Methods. Data from 437 back patients undergoing chiropractic treatment were used for analysis. Patients completed the BQ before treatment and 4 weeks later. Patients also completed the Patient Global Impression of Change scale at follow-up. Responsiveness was determined by calculating Standardized Response Means (SRM) and by the area under the receiver operator curve (ROC) with best cut-point analysis. The minimal clinically important change (MCIC) was calculated by the change score with the best balanced sensitivity and specificity. Results. The responsiveness of the BQ at 4 weeks was dependent on both duration and severity of the condition. As expected, the responsiveness of the total BQ was greater in improved compared to nonimproved patients in the acute (SRM [95% confidence interval], 1.9 [1.7–2.0] and 1.2 [0.9–1.5], respectively), as well as in the subacute/chronic group (SRM, 1.7 [1.5–1.8] and 0.5 [0.3–0.7]), respectively. For the psychological domains, SRMs in the acute patients failed to distinguish improved from nonimproved patients (SRM [95% confidence interval], 1.3 [1.1–1.4] and 0.9 [0.5–1.2] for anxiety, and 0.9 [0.8–1.0] and 0.8 [0.5–1.2] for depression). In acute and subacute/chronic patients, the MCIC for the total BQ was 26 and 18 points, respectively. In patients with lower and higher BQ scores at baseline, the MCIC was 10 and 31 points, respectively. Conclusion. The BQ can distinguish between improved and nonimproved LBP patients but the amount of change needed to achieve this is lower in more chronic patients and in individuals with less severe presentation at baseline.

Evaluation of a general practitioner referral service for manual treatment of back and neck pain

AIM To describe and evaluate a community-based musculoskeletal service, commissioned by National Health Services North East Essex Primary Care Trust (PCT), in terms of patient-reported outcomes and satisfaction. BACKGROUND Persistent musculoskeletal conditions, including back and neck pain, are costly in terms of primary and secondary healthcare resources. Most patients are assessed and managed by general practitioners (GPs), with referral when necessary to secondary care services. METHOD Patients consulting for at least four weeks for back or neck pain were referred by their GP according to patient preference to either a chiropractor or osteopath or physiotherapist working in the independent sector. Patients completed questionnaires at baseline and at discharge from the service. RESULTS Questionnaire data were obtained from 696 patients, 97% of whom were seen within two weeks. About half (51%) had had their pain for less than three months, and of the remainder 49% for more than 12 months. Patients received on average six treatments. Using the Bournemouth Questionnaire, the Bothersomeness scale and the Global Improvement Scale, approximately two-thirds (64.6%, 67.8% and 69.9%, respectively) reported improvement at discharge, and approximately 65% a significant reduction in medication. Almost all (99.5%) patients were satisfied with the service. Similarly, almost all (97%) patients were discharged from the service with advice on self-management; the remainder were recommended for secondary care referral. CONCLUSION This service improved patient access and choice resulting in shorter waiting times and effective outcomes. An impact analysis of the first 12 months of the service by the PCT showed a reduction in primary care consultations and in inappropriate referrals to secondary care.

Predictors of outcome in neck pain patients undergoing chiropractic care: comparison of acute and chronic patients

BackgroundNeck pain is a common complaint in patients presenting for chiropractic treatment. The few studies on predictors for improvement in patients while undergoing treatment identify duration of symptoms, neck stiffness and number of previous episodes as the strong predictor variables. The purpose of this study is to continue the research for predictors of a positive outcome in neck pain patients undergoing chiropractic treatment.MethodsAcute (< 4 weeks) (n = 274) and chronic (> 3 months) (n = 255) neck pain patients with no chiropractic or manual therapy in the prior 3 months were included. Patients completed the numerical pain rating scale (NRS) and Bournemouth questionnaire (BQ) at baseline prior to treatment. At 1 week, 1 month and 3 months after start of treatment the NRS and BQ were completed along with the Patient Global Impression of Change (PGIC) scale. Demographic information was provided by the clinician. Improvement at each of the follow up points was categorized using the PGIC. Multivariate regression analyses were done to determine significant independent predictors of improvement.ResultsBaseline mean neck pain and total disability scores were significantly (p < 0.001and p < 0.008 respectively) higher in acute patients. Both groups reported significant improvement at all data collection time points, but was significantly larger for acute patients. The PGIC score at 1 week (OR = 3.35, 95% CI = 1.13-9.92) and the baseline to 1 month BQ total change score (OR = 1.07, 95% CI = 1.03-1.11) were identified as independent predictors of improvement at 3 months for acute patients. Chronic patients who reported improvement on the PGIC at 1 month were more likely to be improved at 3 months (OR = 6.04, 95% CI = 2.76-13.69). The presence of cervical radiculopathy or dizziness was not predictive of a negative outcome in these patients.ConclusionsThe most consistent predictor of clinically relevant improvement at both 1 and 3 months after the start of chiropractic treatment for both acute and chronic patients is if they report improvement early in the course of treatment. The co-existence of either radiculopathy or dizziness however do not imply poorer prognosis in these patients.

Efficacy of Chiropractic Manual Therapy on Infant Colic: A Pragmatic Single-Blind, Randomized Controlled Trial

OBJECTIVE The purpose of this study was to determine the efficacy of chiropractic manual therapy for infants with unexplained crying behavior and if there was any effect of parental reporting bias. METHODS Infants with unexplained persistent crying (infant colic) were recruited between October 2007 and November 2009 at a chiropractic teaching clinic in the United Kingdom. Infants younger than 8 weeks were randomized to 1 of 3 groups: (i) infant treated, parent aware; (ii) infant treated, parent unaware; and (iii) infant not treated, parent unaware. The primary outcome was a daily crying diary completed by parents over a period of 10 days. Treatments were pragmatic, individualized to examination findings, and consisted of chiropractic manual therapy of the spine. Analysis of covariance was used to investigate differences between groups. RESULTS One hundred four patients were randomized. In parents blinded to treatment allocation, using 2 or less hours of crying per day to determine a clinically significant improvement in crying time, the increased odds of improvement in treated infants compared with those not receiving treatment were statistically significant at day 8 (adjusted odds ratio [OR], 8.1; 95% confidence interval [CI], 1.4-45.0) and at day 10 (adjusted OR, 11.8; 95% CI, 2.1-68.3). The number needed to treat was 3. In contrast, the odds of improvement in treated infants were not significantly different in blinded compared with nonblinded parents (adjusted ORs, 0.7 [95% CI, 0.2-2.0] and 0.5 [95% CI, 0.1-1.6] at days 8 and 10, respectively). CONCLUSIONS In this study, chiropractic manual therapy improved crying behavior in infants with colic. The findings showed that knowledge of treatment by the parent did not appear to contribute to the observed treatment effects in this study. Thus, it is unlikely that observed treatment effect is due to bias on the part of the reporting parent.

Prognostic factors for short-term improvement in acute and persistent musculoskeletal pain consulters in primary care

BackgroundGiven the costs associated with the management of musculoskeletal pain in primary care, predicting the course of these conditions remains a research priority. Much of the research into prognostic indicators however considers musculoskeletal conditions in terms of single pain sites whereas in reality, many patients present with pain in more than one site. The aim of this study was to identify prognostic factors for early improvement in primary care consulters with acute and persistent musculoskeletal conditions across a range of pain sites.MethodsConsecutive patients with a new episode of musculoskeletal pain completed self-report questionnaires at baseline, and then again at the 4/5th treatment visit, and if they were still consulting, at the 10th visit. The outcome was defined as patient self-report improvement sufficient to make a meaningful difference. Independent predictors of outcome were identified using multivariate regression analyses.ResultsAcute (<7 weeks) patients, on average, had more severe conditions in terms of pain, disability, anxiety and work fear-avoidance behaviour than patients with persistent (≥7 weeks) pain, but were more likely to be better by the 4/5th visit. Several variables at baseline were associated with improvement at the 4/5th visit, but the predictive models were weak and unable to discriminate between patients who were improved and those who were not. In contrast, it was possible to elicit a predictive model for improvement later on at the 10th visit, but only in patients with persistent pain. Being employed, reporting a decline in work fear-avoidance behaviour at the 4/5th visit, and being better by the 4/5th visit, were all independently associated with improvement. This model accounted for 34.3% (p < 0.001) of the variation in observed improvement, and had good discriminative ability (the area under receiver operating characteristic (ROC) curve was 0.80 (95%CI 0.73 to 0.86)) and approximate balance in correctly identifying improved and non-improved cases (79.0% and 68% respectively).ConclusionsWe were unable to identify baseline characteristics that predicted early outcome in musculoskeletal pain patients. However, early self-reported improvement and decline in work fear-avoidance behaviour as predictors of later improvement highlighted the importance of speedy recovery in persistent musculoskeletal pain consulters. Our findings reinforce the elusive nature of baseline predictors, and the need for more emphasis on early changes as prognostic predictors in musculoskeletal conditions.

Comparison of two methods of collecting healthcare usage data in chiropractic clinics: patient-report versus documentation in patient files

BackgroundThe use of patient-reported questionnaires to collect information on costs associated with routine healthcare services, such as chiropractic, represents a less labour intensive alternative to retrieving these data from patient files. The aim of this paper was to compare patient-report versus patient files for the collection of data describing healthcare usage in chiropractic clinics.MethodsAs part of a prospective single cohort multi-centre study, data on the number of visits made to chiropractic clinics determined using patient-reported questionnaires or as recorded in patient files were compared three months following the start of treatment. These data were analysed for agreement using the Intraclass Correlation Coefficient (ICC) and the 95% Limits of Agreement.ResultsEighty-nine patients that had undergone chiropractic care were included in the present study. The two methods yielded an ICC of 0.83 (95% CI = 0.75 to 0.88). However, there was a significant difference between the data collection methods, with an average of 0.6 (95% CI = 0.25 to 1.01) additional visits reported in patient files. The 95% Limits of Agreement ranged from 3 fewer visits to 4 additional visits in patient files relative to the number of visits recalled by patients.ConclusionThere was some discrepancy between the number of visits made to the clinic recalled by patients compared to the number recorded in patient files. This should be taken into account in future evaluations of costs of treatments.

Perceptions of the quality of the therapeutic alliance in chiropractic care in The Netherlands: a cross-sectional survey

BackgroundResearch in various medical fields demonstrates a consistent and positive association between clinical outcomes and the quality of the therapeutic alliance between the patient and clinician. The aim of this study was to explore how well chiropractors and their patients in The Netherlands perceive the quality of their working relationship.MethodsA nationwide survey of chiropractors and their patients was conducted in The Netherlands, using a validated Dutch translation of the Working Alliance Inventory (WAV-12). Data were collected over a 5-week period in September-October 2014. Both patients and chiropractors were requested to reflect on 12 statements about to how well they perceived their collaboration in reaching consensus on treatment goals and treatment strategies, and how well they perceived the existence of an affective bond in their working relationship. A 5-point Likert scale was used to answer each question. Higher ratings reflected a more positive perception of the therapeutic alliance. Furthermore, levels of agreement between patients’ and chiropractors’ perceptions of the quality of their therapeutic alliance were determined.ResultsIn total, 207 working relationships between patients and their chiropractor were analysed. The quality of the therapeutic alliance was perceived as being very positive for both patients (n = 183, mean 49.14 ± 7.12) and chiropractors (n = 202, mean 50.48 ± 4.97). There was no difference in patients’ perceptions whether treated by a male or female chiropractor, nor in relation to the chiropractor’s years of experience. Nevertheless, poor agreement was found between perceptions of patients and chiropractors in the same relationship (ICC = 0.13).ConclusionsBoth patients and chiropractors perceived the quality of the therapeutic alliance as being very positive. Despite these positive results, patient and chiropractor pairs perceived the level of collaboration in order to reach agreement on treatment goals and strategies and the quality of their affective bond very differently. Clinically, these results suggest that chiropractors should, during the course of treatment, continue to collaborate with their patient and frequently verify whether their patient continues to agree with the treatment goals and treatment plan applied to further develop, improve and maintain a positive therapeutic alliance.