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Effectiveness Versus Efficacy: More Than a Debate Over Language

By |September 1, 2022|Clinical Effectiveness|

Effectiveness Versus Efficacy: More Than a Debate Over Language

The Chiro.Org Blog


SOURCE:   J Orthop Sports Phys Ther 2003 (Apr); 33 (4): 163–165
Julie M. Fritz, PT, PhD, ATC, Joshua Cleland, PT, DPT, OCS

Department of Physical Therapy,
University of Pittsburgh,
Pittsburgh, PA.



As the physical therapy profession continues the paradigm shift toward evidencebased practice, it becomes increasingly important for therapists to base clinical decisions on the best available evidence. Defining the best available evidence, however, may not be as straightforward as we assume, and will inevitably depend in part upon the perspective and values of the individual making the judgment. To some, the best evidence may be viewed as research that minimizes bias to the greatest extent possible, while others may prioritize research that is deemed most pertinent to clinical practice. The evidence most highly valued and ultimately judged to be the best may differ based on which perspective predominates. One issue that highlights the importance of perspective in judging the evidence is the difference between efficacy and effectiveness approaches to research. These terms are frequently assumed to be synonyms and are often used incorrectly in the literature. There is actually a meaningful distinction between efficacy and effectiveness approaches to research. The distinction is not merely a pedantic concern within the lexicon of researchers, but impacts the nature of the results disseminated by a study, how the results may be applied to clinical practice, and finally how the results are judged by those who seek to evaluate the evidence. [5] Understanding the contrast between effectiveness and efficacy has important and very practical implications for those who seek to evaluate and apply research evidence to clinical practice.

Studies using an efficacy approach are designed to investigate the benefits of an intervention under ideal and highly controlled conditions. While this approach has many methodological advantages, efficacy studies frequently entail substantial deviations from clinical practice in the study design, including the elimination of treatment preferences and multimodal treatment programs, control of the skill levels of the clinicians delivering the intervention, and restrictive control over the study sample. [3, 13] The preferred design for efficacy studies is the randomized controlled trial, frequently employing a no-treatment or placebo group as a comparison in order to isolate the effects of 1 particular intervention. [7] Studies using an efficacy approach have high internal validity and typically score highly on scales designed by researchers to evaluate the quality of clinical trials. However, the generalizability of the results of efficacy studies to the typical practice setting has been questioned. [2] In clinical practice, therapists tend to use many different interventions within a comprehensive treatment program and, therefore, studies investigating the effects of an isolated treatment may appear less useful. In addition, clinical decision making typically entails choices between competing treatment options and, therefore, studies comparing an intervention to an alternative of no intervention (or a placebo intervention) may not seem as directly applicable to the process.

An example of a study using an efficacy approach is a randomized trial by Hides et al. [6] This study examined the effects of exercise on patients with low back pain (LBP). The study used a highly standardized exercise program specifically designed to isolate and strengthen the multifidus muscle. The patient population was restricted to patients with a first episode of unilateral LBP less than 3 weeks in duration. The exercise program was compared to a control group that received no intervention other than medication and advice to remain active. The results of the study favored the group receiving the exercises. The study design permits the conclusion that training the multifidus is beneficial for patients with LBP (versus doing no exercise), however, the generalizability of the results might be questionable.

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Swiss Chiropractic Practice-based Research Network and Musculoskeletal Pain Cohort Pilot Study: Protocol of a Nationwide Resource to Advance Musculoskeletal Health Services Research

By |August 27, 2022|Low Back Pain, Musculoskeletal Pain|

Swiss Chiropractic Practice-based Research Network and Musculoskeletal Pain Cohort Pilot Study: Protocol of a Nationwide Resource to Advance Musculoskeletal Health Services Research

The Chiro.Org Blog


SOURCE:   BMJ Open 2022 (Jul 13); 12 (7): e059380


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Rahim Lalji, Léonie Hofstetter, Alice Kongsted, Viktor von Wyl, Milo A Puhan, and Cesar A Hincapié

Department of Chiropractic Medicine,
Balgrist University Hospital and University of Zurich,
Zurich, Switzerland.



Introduction:   Musculoskeletal (MSK) pain conditions, a leading cause of global disability, are usually first managed in primary care settings such as medical, physiotherapy, and chiropractic community-based practices. While chiropractors often treat MSK conditions, there is limited real-world evidence on the topic of health service outcomes among patients receiving this type of care. A nationwide Swiss chiropractic practice-based research network (PBRN) and MSK pain patient cohort study will have potential to monitor the epidemiological trends of MSK pain conditions and contribute to healthcare quality improvement. The primary aims of this protocol are to (1) describe the development of an MSK-focused PBRN within the Swiss chiropractic setting, and (2) describe the methodology of the first nested study to be conducted within the PBRN-an observational prospective patient cohort pilot study.

Methods and analysis:   This initiative is conceptualised with two distinct phases. Phase I focuses on the development of the Swiss chiropractic PBRN, and will use a cross-sectional design to collect information from chiropractic clinicians nationwide. Phase II will recruit consecutive patients aged 18 years or older with MSK pain from community-based chiropractic practices participating in the PBRN into a prospective chiropractic cohort pilot study. All data collection will occur through electronic surveys offered in the three Swiss official languages (German, French, Italian) and English. Surveys will be provided to patients prior to their initial consultation in clinics, 1 hour after initial consultation, and at 2, 6 and 12 weeks after initial consultation.

Ethics and dissemination:   Ethics approval has been obtained from the independent research ethics committee of Canton Zurich (BASEC-Nr: 2021-01479). Informed consent will be obtained electronically from all participants.

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SPINAL PAIN MANAGEMENT Section

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Association Between Chiropractic Spinal Manipulative Therapy and Benzodiazepine Prescription in Patients with Radicular Low Back Pain: A Retrospective Cohort Study Using Real-world Data From the USA

By |July 7, 2022|Low Back Pain, Nonpharmacologic Therapies|

Association Between Chiropractic Spinal Manipulative Therapy and Benzodiazepine Prescription in Patients with Radicular Low Back Pain: A Retrospective Cohort Study Using Real-world Data From the USA

The Chiro.Org Blog


SOURCE:   BMJ Open 2022 (Jun 13); 12 (6): e058769


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Robert James Trager, Zachary A Cupler, Kayla J DeLano, Jaime A Perez, Jeffery A Dusek

Connor Whole Health, University Hospitals Cleveland Medical Center,
Cleveland, Ohio, USA



Objectives:   Although chiropractic spinal manipulative therapy (CSMT) and prescription benzodiazepines are common treatments for radicular low back pain (rLBP), no research has examined the relationship between these interventions. We hypothesise that utilisation of CSMT for newly diagnosed rLBP is associated with reduced odds of benzodiazepine prescription through 12 months’ follow-up.

Design:   Retrospective cohort study.

Setting:   National, multicentre 73-million-patient electronic health records-based network (TriNetX) in the USA, queried on 30 July 2021, yielding data from 2003 to the date of query.

Participants:   Adults aged 18-49 with an index diagnosis of rLBP were included. Serious aetiologies of low back pain, structural deformities, alternative neurological lesions and absolute benzodiazepine contraindications were excluded. Patients were assigned to cohorts according to CSMT receipt or absence. Propensity score matching was used to control for covariates that could influence the likelihood of benzodiazepine utilisation.

Outcome measures:   The number, percentage and OR of patients receiving a benzodiazepine prescription over 3, 6 and 12 months’ follow-up prematching and postmatching.

Results:   After matching, there were 9206 patients (mean (SD) age, 37.6 (8.3) years, 54% male) per cohort. Odds of receiving a benzodiazepine prescription were significantly lower in the CSMT cohort over all follow-up windows prematching and postmatching (p<0.0001). After matching, the OR (95% CI) of benzodiazepine prescription at 3 months was 0.56 (0.50 to 0.64), at 6 months 0.61 (0.55 to 0.68) and 12 months 0.67 (0.62 to 0.74). Sensitivity analysis suggested a patient preference to avoid prescription medications did not explain the study findings.

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NON-PHARMACOLOGIC THERAPY Section

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Associations Between Early Chiropractic Care and Physical Therapy on Subsequent Opioid Use Among Persons With Low Back Pain in Arkansas

By |July 5, 2022|Chiropractic Management, Nonpharmacologic Therapies|

Associations Between Early Chiropractic Care and Physical Therapy on Subsequent Opioid Use Among Persons With Low Back Pain in Arkansas

The Chiro.Org Blog


SOURCE:   J Chiropractic Medicine 2022 (Jun); 21 (2): 67–76
Mahip Acharya, BPharm, Dvyan Chopra, MS, Allen M. Smith, PharmD, Julie M. Fritz, PhD, PT, Bradley C. Martin, PharmD, PhD

Division of Pharmaceutical Evaluation and Policy,
University of Arkansas for Medical Sciences,
Little Rock, Arkansas.

Department of Physical Therapy and Athletic Training,
University of Utah,
Salt Lake City, Utah.



Editorial Comment:   These authors are to be praised for publishing this paper. When you look at their pedigrees, it’s reasonable to imagine that they may have been looking to see that physical therapy was associated with reduced opioid use. Numerous studies have shown that chiropractic already has a well-established track record for low- to no-opioid use, so they would be the perfect comparison group for a study like this. We all know that third parties are looking for safe and cost-effective alternatives to “usual care”.

In the past, a study favorable to chiropractic care, particularly one that used physical therapy as a comparison group, would never have been published, because of the long-standing medical bias against chiropractic care. So, let’s tip our hats to this group of researchers for their hard work and honesty!


Objective:   The objective of this study was to estimate the association between early use of physical therapy (PT) or chiropractic care and incident opioid use and long-term opioid use in individuals with a low back pain (LBP) diagnosis.

Methods:   A retrospective cohort study was conducted using data from Arkansas All Payers’ Claims Database. Adults with incident LBP diagnosed in primary care or emergency departments between July 1, 2013, and June 30, 2017, were identified. Participants were required to be opioid naïve in the 6-month baseline period and without cancer, cauda equina syndrome, osteomyelitis, lumbar fracture, and paraplegia/quadriplegia in the entire study period. PT and chiropractic treatment were documented over the ensuing 30 days starting on the date of LBP. Any opioid use and long-term opioid use (LTOU) in 1-year follow-up were assessed. Multivariable logistic regressions controlling for covariates were estimated.

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NON-PHARMACOLOGIC THERAPY Section

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Acute Inflammatory Response via Neutrophil Activation Protects Against the Development of Chronic Pain

By |June 12, 2022|Chiropractic Care, Chronic Pain Management|

Acute Inflammatory Response via Neutrophil Activation Protects Against the Development of Chronic Pain

The Chiro.Org Blog


SOURCE:   Science Translational Medicine 2022 (May 11)

Marc Parisien, Lucas V Lima, Concetta Dagostino, Nehme El-Hachem, Gillian L Drury, et. al.

Faculty of Dental Medicine and Oral Health Sciences,
Department of Anesthesia, Faculty of Medicine,
Alan Edwards Centre for Research on Pain,
McGill University,
Montreal, Quebec H3A 1G1, Canada.



Editorial Comment:

This novel new study suggests that prolonged NSAIDs use may be a cause of persistent pain. The authors stated:

Analysis of pain trajectories of human subjects reporting acute back pain in the UK Biobank identified elevated risk of pain persistence for subjects taking NSAIDs. Thus, despite analgesic efficacy at early time points, the management of acute inflammation may be counterproductive for long-term outcomes of LBP sufferers.”

FROM:   Pain Research Forum


Neutrophils Put the Brakes on Acute Pain Becoming Chronic

Neutrophils help prevent the transition from acute to chronic pain after injury.
Dampening their activity with anti-inflammatory drugs, like ibuprofen or diclofenac, can prolong pain duration
.


by Fred Schwaller on 25 May 2022

In the last few weeks, several news outlets like The New York Times and The Guardian have published provocative stories warning their readers that taking analgesics, like ibuprofen, can lead to the development of chronic back pain.

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Characteristics, Expectations, Experiences of Care, and Satisfaction of Patients Receiving Chiropractic Care in a French University Hospital in Toulouse (France) Over One Year: A Case Study

By |June 10, 2022|Cost-Effectiveness of Chiropractic, Patient Satisfaction|

Characteristics, Expectations, Experiences of Care, and Satisfaction of Patients Receiving Chiropractic Care in a French University Hospital in Toulouse (France) Over One Year: A Case Study

The Chiro.Org Blog


SOURCE:   BMC Musculoskelet Disord 2022 (Mar 9); 23 (1): 229

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Mallard F, Lemeunier N, Mior S, Pecourneau V, and Côté P

Division of Graduate Studies,
Canadian Memorial Chiropractic College (CMCC),
Toronto, Ontario, Canada.



FROM: ChiroUp (2021)


Background:   In October 2017, a partnership was established between the University Hospital of Toulouse and the French Chiropractic College, “Institut Franco-Européen de Chiropraxie” (IFEC). Before 2017, chiropractors did not practice in hospitals in France. Chiropractic students and chiropractors are now integrated in an interdisciplinary medical team at University Hospital. Our study aimed to describe the characteristics of patients who received chiropractic care at the University Hospital of Toulouse, their expectations, experiences of care, and satisfaction.

Method:   A prospective case study was conducted. Patients referred for chiropractic care in the French University Hospital of Toulouse from January to December 2020 were eligible to participate. Participants provided the following data: demographics, previous chiropractic care treatments, pain location, intensity (NRS) and duration, disability (NDI, ODI), health-related quality of life (SF-12) and depressive symptomatology (PHQ-9). We conducted semi-structured interviews to explore their expectations, barriers and facilitators impacting their experience of care, and satisfaction.

Method:   Seventeen participants were recruited and seven were interviewed. All participants had chronic pain with a median pain intensity of 05/10 (IQR 04-06) on the NRS scale. Nine of 17 participants presented with multiple pain locations. Thirteen of seventeen participants presented with low back pain and eight with neck pain. The median SF-12 health-related quality of life score was 50/100 (IQR 28.5-60.5) for physical health, and 52/100 (IQR 43-62) for mental health. The PHQ-9 median score of depressive symptomatology was 7.7/27 (IQR 2.0-12.5). Overall, participants were satisfied with their care and the collaboration between chiropractors and physicians. Participants expected a caring communication with the chiropractic team. Their experience was facilitated by their trust in their physician. Patients perceived the turnover of chiropractic students as a barrier to their satisfaction.

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