Randomized Controlled Trial

A Structured Protocol of Evidence-based Care

By Frank M. Painter|September 16, 2017|Chiropractic Research, Randomized Controlled Trial|

A Structured Protocol of Evidence-based Conservative Care Compared with Usual Care for Acute Nonspecific Low Back Pain: A Randomized Clinical Trial

SOURCE: Arch Phys Med Rehabil. 2012 (Jan); 93 (1): 11–20

Gregory F. Parkin-Smith, MTech(Chiro), MSc, DrHC,
Ian J. Norman, BSc, MSc, PhD,
Emma Briggs, BSc, PhD, RN,
Elizabeth Angier, BSc, MSc(Chiro),
Timothy G. Wood, BSc, MTech(Chiro),
James W. Brantingham, DC, PhD

School of Chiropractic & Sports Science,
Murdoch University,
Perth, Australia.

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.

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Prevention of Low Back Pain: Effect, Cost-effectiveness, and Cost-utility of Maintenance Care – Study Protocol for a Randomized Clinical Trial

By Frank M. Painter|June 8, 2014|Cost-Effectiveness, Low Back Pain, Maintenance Care, Randomized Controlled Trial|

Prevention of Low Back Pain: Effect, Cost-effectiveness, and Cost-utility of Maintenance Care – Study Protocol for a Randomized Clinical Trial

The Chiro.Org Blog

SOURCE: Trials. 2014 (Apr 2); 15: 102

Andreas Eklund, Iben Axén, Alice Kongsted, Malin Lohela-Karlsson,
Charlotte Leboeuf-Yde, and Irene Jensen

Institute of Environmental Medicine,
Unit of Intervention and Implementation Research,
Karolinska Institutet, Nobels v13, S-171 77
Stockholm, Sweden. andreas.eklund@ki.se.

BACKGROUND: Low back pain (LBP) is a prevalent condition and a socioeconomic problem in many countries. Due to its recurrent nature, the prevention of further episodes (secondary prevention), seems logical. Furthermore, when the condition is persistent, the minimization of symptoms and prevention of deterioration (tertiary prevention), is equally important. Research has largely focused on treatment methods for symptomatic episodes, and little is known about preventive treatment strategies.

METHODS/DESIGN: This study protocol describes a randomized controlled clinical trial in a multicenter setting investigating the effect and cost-effectiveness of preventive manual care (chiropractic maintenance care) in a population of patients with recurrent or persistent LBP.Four hundred consecutive study subjects with recurrent or persistent LBP will be recruited from chiropractic clinics in Sweden. The primary outcome is the number of days with bothersome pain over 12 months. Secondary measures are self-rated health (EQ-5D), function (the Roland Morris Disability Questionnaire), psychological profile (the Multidimensional Pain Inventory), pain intensity (the Numeric Rating Scale), and work absence.The primary utility measure of the study is quality-adjusted life years and will be calculated using the EQ-5D questionnaire. Direct medical costs as well as indirect costs will be considered.

Subjects are randomly allocated into two treatment arms:

1) Symptom-guided treatment (patient controlled), receiving care when patients feel a need.

2) Preventive treatment (clinician controlled), receiving care on a regular basis.

Eligibility screening takes place in two phases: first, when assessing the primary inclusion/exclusion criteria, and then to only include fast responders, i.e., subjects who respond well to initial treatment. Data are collected at baseline and at follow-up as well as weekly, using SMS text messages.

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A Comparison of Chiropractic Manipulation Methods and Usual Medical Care for Low Back Pain: A Randomized Controlled Clinical Trial

By Frank M. Painter|June 6, 2014|Chiropractic Care, Low Back Pain, Randomized Controlled Trial|

A Comparison of Chiropractic Manipulation Methods and Usual Medical Care for Low Back Pain: A Randomized Controlled Clinical Trial

The Chiro.Org Blog

SOURCE: J Altern Complement Med. 2014 (May); 20 (5): A22–23

Michael Schneider, Mitchell Haas, Joel Stevans, Ronald Glick, Doug Landsittel

Michael Schneider, mjs5@pitt.edu
University of Pittsburgh, Pittsburgh, PA, USA

Purpose: The primary aim of this study was to compare manual and mechanical methods of spinal manipulation (Activator) for patients with acute and sub-acute low back pain. These are the two most common methods of spinal manipulation used by chiropractors, but there is insufficient evidence regarding their comparative effectiveness against each other. Our secondary aim was to compare both methods with usual medical care.

Methods: In a randomized comparative effectiveness trial, we randomized 107 participants with acute and sub-acute low back pain to: 1) usual medical care; 2) manual side-posture manipulation; and 3) mechanical manipulation (Activator). The primary outcome was self-reported disability (Oswestry) at four weeks. Pain was rated on a 0 to 10 numerical rating scale. Pain and disability scores were regressed on grouping variables adjusted for baseline covariates.

Results: Manual manipulation demonstrated a clinically important and statistically significant reduction of disability and pain compared to Activator (adjusted mean difference=7.9 and 1.3 points respectively, P<.05) and compared to usual medical care (7.0 and 1.8 points respectively, P<.05). There were no significant adjusted mean differences between Activator and usual medical care in disability and pain (0.9 and 0.5 points respectively, P>.05).

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Costs of Routine Care For Infant Colic in the UK and Costs

By Frank M. Painter|February 2, 2014|Chiropractic Care, Colic, Cost-Effectiveness, Randomized Controlled Trial|

Costs of Routine Care For Infant Colic in the UK and Costs of Chiropractic Manual Therapy as a Management Strategy Alongside a RCT For This Condition

The Chiro.Org Blog

SOURCE: J Clin Chiropr Pediatr 2013 (Jun); 14 (1): 1063–1069

Joyce E. Miller, BS, DC, DABCO

Anglo-European College of Chiropractic,
Bournemouth, UK.

This paper is a follow-up cost comparison of the medical and chiropractic care provided in Dr. Miller’s RTC study:

Efficacy of Chiropractic Manual Therapy on Infant Colic: A Pragmatic Single-Blind, Randomized Controlled Trial
J Manipulative Physiol Ther. 2012 (Oct); 35 (8): 600–607

This RTC cast new and significant insight onto previous colic trials:

In this study, it was found that knowledge of treatment by the parent did not appear to contribute to the observed treatment effects. This was a major criticism of earlier colic studies, and thus may help support their conclusions.

That study revealed that excessively crying infants were 5 times less likely to cry significantly, if they were treated with chiropractic manual therapy, and that chiropractic care reduced their crying times by about 50%, compared with those infants provided solely medical management.

Background: There is a small body of published research (six research studies and a Cochrane review) suggesting that manual therapy is effective in the treatment of infant colic. Research from the UK has shown that the costs of NHS treatment are high (£65 million [USD100 million] in 2001) with no alleviation of the condition.

Objectives: The objectives of this study were to: investigate the cost of the inconsolable nocturnal crying infant syndrome which is popularly known as infant colic in the first 20 weeks of life, estimate the costs of different types of treatment commonly chosen by parents for a colicky infant for a week of care or an episode of care, investigate the cost of chiropractic manual therapy intervention aimed at reducing the hours of infant crying alongside a randomized controlled trial (RCT) showing effectiveness of treatment.

Design: Economic evaluation incorporating a RCT.

Methods: A cost analysis was conducted using data from a RCT conducted in a three-armed single-blinded trial that randomized excessively crying infants into one of three groups: a) routine chiropractic manual therapy (CMT), b) CMT with parent blinded or c) no treatment control group with parent blinded. These costs were compared with costs of caring for infant colic from Unit Costs of Health and Social Care, UK, 2011. It has been widely estimated that 21% of infants in the UK present annually to primary care for excessive crying and this calculated to 167,000 infants (to the nearest 1,000) used in the cost analysis as there were 795,249 infants in the UK in mid-2010 according to the UK Office of National Statistics, 2011.

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Outcomes of Usual Chiropractic; Harm (OUCH) Randomised Controlled Trial of Adverse Events

By Frank M. Painter|September 24, 2013|Adverse Events, Chiropractic Care, Randomized Controlled Trial|

Outcomes of Usual Chiropractic; Harm (OUCH) Randomised Controlled Trial of Adverse Events

The Chiro.Org Blog

SOURCE: Spine 2013 (Sep 15); 38 (20): 1723-9 ~ FULL TEXT

Walker, Bruce F. DC, MPH, DrPH; Hebert, Jeffrey J. DC, PhD;
Stomski, Norman J. BHSc (hons), PhD; Clarke

Murdoch University School of Engineering and Information Technology,
Mathematics & Statistics,
Murdoch University Centre for Health,
Exercise and Sports Medicine,
University of Melbourne.

Study Design. Blinded parallel-group randomized controlled trial.

Objective. Establish the frequency and severity of adverse effects from short-term usual chiropractic treatment of the spine when compared with a sham treatment group.

Summary of Background Data. Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, as a result of design limitations in previous studies, particularly the lack of sham-controlled randomized trials, understanding of these adverse events and their relation with chiropractic treatment is suboptimal.

Methods. We conducted a trial to examine the occurrence of adverse events resulting from chiropractic treatment. It was conducted across 12 chiropractic clinics in Perth, Western Australia. The participants comprised 183 adults, aged 20 to 85 years, with spinal pain. Ninety-two participants received individualized care consistent with the chiropractors’ usual treatment approach; 91 participants received a sham intervention. Each participant received 2 treatments.

Results. Completed adverse questionnaires were returned by 94.5% of the participants after appointment 1 and 91.3% after appointment 2. Thirty-three percent of the sham group and 42% of the usual care group reported at least 1 adverse event. Common adverse events were:

increased pain (sham 29%; usual care 36%),
muscle stiffness (sham 29%; usual care 37%),
and headache (sham 17%; usual care 9%).

The relative risk (RR) was not significant for adverse event occurrence (RR = 1.24; 95% CI: 0.85–1.81),
occurrence of severe adverse events (RR = 1.9; 95% CI: 0.98–3.99),
adverse event onset (RR = 0.16; 95% CI: 0.02–1.34),
or adverse event duration (RR = 1.13; 95% CI: 0.59–2.18).
No serious adverse events were reported.

Conclusion. A substantial proportion of (previously reported) adverse events following chiropractic treatment appear to result from natural history variation and nonspecific effects.

From the FULL TEXT Article

Introduction

Chiropractic therapy is commonly used to manage musculoskeletal conditions in high-income countries. [1, 2] The occurrence of adverse events resulting from chiropractic treatment is of considerable interest to chiropractors and the general public. Most adverse events associated with chiropractic treatment are mild, short lasting, and typical of musculoskeletal condition symptoms. [3–11] However, due to a lack of appropriately designed studies, particularly sham-controlled trials, there are differences in views about what constitutes a chiropractic treatment–related adverse event.

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Havard’s School of Public Health and Medical School sponsoring their course in clinical trials for FREE.

By stevev|June 9, 2013|Education, Ethics, Medicine, Public Health, Randomized Controlled Trial, Research|

HSPH-HMS214X Fundamentals of Clinical Trials is just one of the courses offered at www.edx.org.

Ever wonder what it would be like to take a course offered at an Ivy League University? Wonder no more! Harvard is part of a consortium of the most prestigious Universities in the world that is offering MOOC‘s (Massive Open Online Courses). There are no costs involved in taking a MOOC and you get all the same information that you would in an on ground course. The only differences are that you don’t get the instructor (or even TA’s) grading your papers nor will you get college credit on a transcript from Harvard. They are however the same information used in the universities’ on ground for-credit courses that can cost thousands of dollars.

MOOC’s typically use open source materials (available at no charge for personal use) and a type of self grading system based off of discussion forums in the course (It is totally up to the professor how that is handled, so it will vary depending on the course and instructor). They are a combination of one answer to cutting high educational and making it available to everyone.

The course begins October 14, 2013, runs a total of 13 weeks and depending on your background will take between 4-6 hours of your time each week. A background in biostatistics and epidemiology equivalent to the content of PH207X Health in Numbers: Quantitative Methods in Clinical & Public Health Research.

From the course site;

“This course will provide an introduction to the scientific, statistical, and ethical aspects of clinical trials research. Topics include the design, implementation, and analysis of trials, including first-in-human studies (dose-finding, safety, proof of concept, and Phase I), Phase II, Phase III, and Phase IV studies. All aspects of the development of a study protocol will be addressed, including criteria for the selection of participants, treatments, and endpoints, randomization procedures, sample size determination, data analysis, and study interpretation. The ethical issues that arise at each phase of therapy development will be explored.”

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