Critique of a practice-based pilot study in chiropractic practices in Western Australia.

BACKGROUND: Practice-based data collection can offer insight into the nature of chiropractic practice and contribute to resolving the conundrum of the chiropractic profession's role in contemporary healthcare, subsequently informing care service policy. However, there is little formal data available about chiropractic practice to inform decision-makers about the nature and role of chiropractic within the context of a modern multidisciplinary healthcare context in Australia, particularly at a local and regional level. METHODS: This was a mixed-methods data transformation model (qualitative to quantitative) pilot study the purpose of which was to provide a critique of the research design and collect data from a selected sample of chiropractic practices in Western Australia, with a view to offer recommendations related to the design, feasibility and implementation of a future confirmatory study. RESULTS: A narrative critique of the research methods of this pilot study is offered in this paper covering: (a) practice and patient recruitment, (b) enrollment of patients, (c) data collection methods, (d) acceptability of the study methods, (e) sample size calculations, and (f) design critique. CONCLUSIONS: The result of this critique provides a sensible sample size estimate and recommendations as to the design and implementation of a future confirmatory study. Furthermore, we believe that a confirmatory study is not only feasible, but indeed necessary, with a view to offer meaningful insight into chiropractic practice in Western Australia. TRIAL REGISTRATION: ACTRN12616000434493 Australian New Zealand Clinical Trials Registry (ANZCTR). Registered 5 April 2016. First participant enrolled 01 July 2014, retrospectively registered.

Outcomes of a pilot study in chiropractic practices in Western Australia.

BACKGROUND: This paper reports the quantitative outcomes of a mixed-methods pilot study of the characteristics and demographics of chiropractic practices and patients in Western Australia. METHODS: This was a mixed-methods data transformation model (qualitative to quantitative) pilot study. A non-random sample of chiropractic practices across Western Australia was recruited and data collected anonymously from consecutive new patients using an online platform. Data covered practice and patient demographics and characteristics, alongside quality of life measures. A descriptive quantitative analysis characterised the sample, and the patient population was stratified by main reason for presentation to compare characteristics according to the presence of secondary complaints. Odds ratios were calculated to estimate the odds of a secondary complaint for various combinations of main complaints, from univariate logistic regression models. RESULTS: Of the 539 registered practitioners in WA in July 2014, 33 agreed to participate, from 20 different practices. Ten participating practices provided data on 325 adult new patients. The recruited practices (metropolitan n = 8, regional n = 2) had a positive response rate of 79.7 % (n = 301 metropolitan and n = 24 regional patients), mean age 36.3 years (range 18-74) (53.2 % female). Spinal problems were reported as the main reason for consultation by 67 % and as secondary reasons by 77.2 % of patients. People presented primarily for health maintenance or a general health check in 11.4 %, and as a secondary reason 14.8 %. There were 30 % of people below societal norms for the SF-12 Physical Component Score (mean 47.19, 95 % CI; 46.27-48.19) and 86 % for the Mental Component Score (mean 36.64, 95 % CI; 35.93-37.65), Pain Impact Questionnaire mean scores were 54.60 (95 % CI; 53.32-55.88). CONCLUSIONS: Patients presented to chiropractors in Western Australia with a fairly wide range of conditions, but primarily spinal and musculoskeletal-related problems. A significant proportion of patients had associated, or found to be at risk of, depression. Consequently, there are responsibilities and opportunities for chiropractors with respect to providing care services that include health promotion and well-being education related to musculoskeletal/spinal and mental health. This pilot study supports the feasibility of a future confirmatory study where the potential role of chiropractors in spinal/musculoskeletal health management may be explored. TRIAL REGISTRATION: ACTRN12616000434493: Australian New Zealand Clinical Trials Registry (ANZCTR), Registered 5 April 2016, First participant enrolled 01 July 2014 Retrospectively Registered.

Manipulative therapy and rehabilitation for recurrent ankle sprain with functional instability: a short-term, assessor-blind, parallel-group randomized trial.

OBJECTIVE: The purpose of this study was to compare manipulative therapy (MT) plus rehabilitation to rehabilitation alone for recurrent ankle sprain with functional instability (RASFI) to determine short-term outcomes. METHODS: This was an assessor-blind, parallel-group randomized comparative trial. Thirty-three eligible participants with RASFI were randomly allocated to receive rehabilitation alone or chiropractic MT plus rehabilitation. All participants undertook a daily rehabilitation program over the course of the 4-week treatment period. The participants receiving MT had 6 treatments over the same treatment period. The primary outcome measures were the Foot and Ankle Disability Index and the visual analogue pain scale, with the secondary outcome measure being joint motion palpation. Data were collected at baseline and during week 5. Missing scores were replaced using a multiple imputation method. Statistical analysis of the data composed of repeated-measures analysis of variance. RESULTS: Between-group analysis demonstrated a difference in scores at the final consultation for the visual analogue scale and frequency of joint motion restrictions (P ≤ .006) but not for the Foot and Ankle Disability Index (P = .26). CONCLUSIONS: This study showed that the patients with RASFI who received chiropractic MT plus rehabilitation showed significant short-term reduction in pain and the number of joint restrictions in the short-term but not disability when compared with rehabilitation alone.

Manual and manipulative therapy in addition to rehabilitation for osteoarthritis of the knee: assessor-blind randomized pilot trial.

OBJECTIVES: The purpose of this study was to examine the methodological integrity, sample size requirements, and short-term preliminary clinical outcomes of manual and manipulative therapy (MMT) in addition to a rehabilitation program for symptomatic knee osteoarthritis (OA). METHODS: This was a pilot study of an assessor-blinded, randomized, parallel-group trial in 2 independent university-based outpatient clinics. Participants with knee OA were randomized to 3 groups: 6 MMT sessions alone, training in rehabilitation followed by a home rehabilitation program alone, or MMT plus the same rehabilitation program, respectively. Six MMT treatment sessions (provided by a chiropractic intern under supervision or by an experienced chiropractor) were provided to participants over the 4-week treatment period. The primary outcome was a description of the research methodology and sample size estimation for a confirmatory study. The secondary outcome was the short-term preliminary clinical outcomes. Data were collected at baseline and 5weeks using the Western Ontario and McMasters Osteoarthritis Index questionnaire, goniometry for knee flexion/extension, and the McMaster Overall Therapy Effectiveness inventory. Analysis of variance was used to compare differences between groups. RESULTS: Eighty-three patients were randomly allocated to 1 of the 3 groups (27, 28, and 28, respectively). Despite 5 dropouts, the data from 78 participants were available for analysis with 10% of scores missing. A minimum of 462 patients is required for a confirmatory 3-arm trial including the respective interventions, accounting for cluster effects and a 20% dropout rate. Statistically significant and clinically meaningful changes in scores from baseline to week 5 were found for all groups for the Western Ontario and McMasters Osteoarthritis Index (P ≤ .008), with a greater change in scores for MMT and MMT plus rehabilitation. Between-group comparison did not reveal statistically significant differences between group scores at week 5 for any of the outcome measures (P ≥ .46). CONCLUSIONS: This pilot trial suggests that a confirmatory trial is feasible. There were significant changes in scores from baseline to week 5 across all groups, suggesting that all 3 treatment approaches may be of benefit to patients with mild-to-moderate knee OA, justifying a confirmatory trial to compare these interventions.

Clinical decision-making to facilitate appropriate patient management in chiropractic practice: 'the 3-questions model'.

BACKGROUND: A definitive diagnosis in chiropractic clinical practice is frequently elusive, yet decisions around management are still necessary. Often, a clinical impression is made after the exclusion of serious illness or injury, and care provided within the context of diagnostic uncertainty. Rather than focussing on labelling the condition, the clinician may choose to develop a defendable management plan since the response to treatment often clarifies the diagnosis. DISCUSSION: This paper explores the concept and elements of defensive problem-solving practice, with a view to developing a model of agile, pragmatic decision-making amenable to real-world application. A theoretical framework that reflects the elements of this approach will be offered in order to validate the potential of a so called '3-Questions Model'; SUMMARY: Clinical decision-making is considered to be a key characteristic of any modern healthcare practitioner. It is, thus, prudent for chiropractors to re-visit the concept of defensible practice with a view to facilitate capable clinical decision-making and competent patient examination skills. In turn, the perception of competence and trustworthiness of chiropractors within the wider healthcare community helps integration of chiropractic services into broader healthcare settings.

A structured protocol of evidence-based conservative care compared with usual care for acute nonspecific low back pain: a randomized clinical trial.

OBJECTIVE: To compare a protocol of evidence-based conservative care with usual care for acute nonspecific low back pain (LBP) of less than 6 weeks' duration. DESIGN: Parallel-group randomized trial. SETTING: Three practices in the United Kingdom. PARTICIPANTS: Convenience sample of 149 eligible patients were invited to participate in the study, with 118 volunteers being consented and randomly allocated to a treatment group. INTERVENTIONS: The experimental group received evidence-based treatments for acute nonspecific LBP as prescribed in a structured protocol of care developed for this study. The control group received usual conservative care. Participants in both groups could receive up to 7 treatments over a 4-week period. MAIN OUTCOME MEASURES: Oswestry Low Back Disability Index (ODI), visual analog scale (VAS), and Patient Satisfaction Questionnaire, alongside estimation of clinically meaningful outcomes. RESULTS: Total dropout rate was 14% (n=16), with 13% of data missing. Missing data were replaced using a multiple imputation method. Participants in both groups received an average of 6 treatments. There was no statistically significant difference in disability (ODI) scores at the end of week 4 (P=.33), but there was for pain (VAS) scores (P<.001). Interestingly, there were statistically significant differences between the 2 groups for both disability and pain measures at the midpoint of the treatment period (P<.001). Patient satisfaction with care was equally high (85%) in both groups. Minimally clinically important differences in scores and number needed to treat scores (NNT<6) indicated that the experimental treatment (protocol of care) offered a clinically meaningful benefit over the control treatment (usual care), particularly at the midpoint of the treatment period. CONCLUSIONS: Overall, the 2 treatment groups were similar based on primary or secondary outcome measure scores for the full treatment period (4 weeks, with up to 7 treatments). However, there were statistically significant and clinically meaningful differences in both disability and pain scores at week 2 (midpoint) with 4 treatments, suggesting that the protocol of care had a more rapid effect than usual care.

Manual and manipulative therapy compared to night splint for symptomatic hallux abducto valgus: an exploratory randomised clinical trial.

CONTEXT: Hallux abducto valgus (HAV) is a frequent cause of great toe pain and disability, yet common treatments are only supported by mixed or equivocal research findings. Surgery often only provides modest improvement and post-surgery complications may significantly hamper outcomes, implying the need for trials testing conservative treatment, such as manual and manipulative therapy, particularly in cases where surgery may be contraindicated or premature. The purpose of this exploratory trial was to test an innovative protocol of manual and manipulative therapy (MMT) and compare it to standard care of a night splint(s) for symptomatic mild to moderate HAV, with a view gather insight into the effectiveness of MMT and inform the design of a definitive trial. DESIGN: Parallel-group randomised trial set in an out-patient teaching clinic. PARTICIPANTS: A convenience sample of 75 patients was assessed for eligibility, with 30 participants (15 per group) being consented and randomly allocated to either the control group (standard care with a night splint) or the experimental group (MMT). INTERVENTION: Participants in the control group used a night splint(s) and those in the experimental group (MMT) received a structured protocol of MMT, with the participants in the experimental group receiving 4 treatments over a 2-week period. OUTCOME MEASURES: Visual analogue scale (HAV-related pain), foot function index (HAV-related disability) and hallux dorsiflexion (goniometry). RESULTS: There were no participant dropouts and no data was missing. There were no statistical (p<0.05) or clinically meaningful differences (MCID<20%) between the two groups based on outcome measure scores. However, the outcome measure scores in the control group (night splint) regressed between the 1-week follow-up and 1-month follow-up, while the scores in the experimental group (MMT) were sustained up to the 1-month follow-up. The within-group data analysis produced statistically and clinically significant changes from baseline to the 1-week flow-up across all outcome measures. Post hoc power analysis and sample size calculations suggest that the average between group power of this trial was approximately 60% (ES = 0.33) and that a definitive trial would require a minimum of 102 participants per group (N = 204) to achieve satisfactory power of ≥80%. CONCLUSIONS: The trend in results of this trial suggest that an innovative structured protocol of manual and manipulative therapy (experimental group) is equivalent to standard care of a night splint(s) (control group) for symptomatic mild to moderate HAV in the short term. The protocol of MMT maintains its treatment effect from 1-week to 1-month follow-up without further treatment, while patients receiving standard care seem to regress when not using the night splint. Insights from this study support further testing of MMT for symptomatic mild to moderate HAV, particularly where surgery is premature or where surgical outcomes may be equivocal, and serve to inform the design of a future definitive trial.