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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

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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Function in Patients With Cervical Radiculopathy or Chronic Whiplash-Associated Disorders Compared With Healthy Volunteers

By Frank M. Painter|June 5, 2014|Rehabilitation, Whiplash|

Function in Patients With Cervical Radiculopathy or Chronic Whiplash-Associated Disorders Compared With Healthy Volunteers

The Chiro.Org Blog

SOURCE: J Manipulative Physiol Ther 2014 (May); 37 (4): 211–218

Anneli Peolsson, PhD, Maria Landén Ludvigsson, MSc, PT, Johanna Wibault, MSc, PT, Åsa Dedering, PhD, PT, Gunnel Peterson, MSc, PT

Anneli Peolsson, Associate Professor, PhD, PT,
Department of Medical and Health Sciences,
Physiotherapy, Hälsans hus plan 12, Campus US,
Linköping University, SE-58183 Linköping, Sweden

Objective The purposes of this study were to examine whether any differences in function and health exist between patients with cervical radiculopathy (CR) due to disk disease scheduled for surgery and patients with chronic whiplash-associated disorders (WADs) and to compare measures of patients’ physical function with those obtained from healthy volunteers.

Methods This is a cross-sectional study of patients with CR (n = 198) and patients with chronic WAD (n = 215). Patient data were compared with raw data previously obtained from healthy people. Physical measures included cervical active range of motion, neck muscle endurance, and hand grip strength. Self-rated measures included pain intensity (visual analog scale), neck disability (Neck Disability Index), self-efficacy (Self-Efficacy Scale), and health-related quality of life (EuroQol 5-dimensional self-classifier).

Results Patient groups exhibited significantly lower performance than the healthy group in all physical measures (P < .0005) except for neck muscle endurance in flexion for women (P > .09). There was a general trend toward worse results in the CR group than the WAD group, with significant differences in neck active range of motion, left hand strength for women, pain intensity, Neck Disability Index, EuroQol 5-dimensional self-classifier, and Self-Efficacy Scale (P < .0001).

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The Evidence House: How to Build an Inclusive Base for Complementary Medicine

By Frank M. Painter|June 3, 2014|Evidence-based Medicine|

The Evidence House: How to Build an Inclusive Base for Complementary Medicine

The Chiro.Org Blog

SOURCE: West J Med 2001 (Aug); 175 (2): 79–80

Wayne B Jonas

Department of Family Medicine Uniformed Services
University of the Health Sciences
Bethesda, MD 20814

We all want good evidence available when making medical decisions. Evidence, however, comes in a variety of forms and purposes, and what may be good for one purpose may not be good for another. The term “evidence-based medicine” (EBM) has become almost a cliché in recent years, being used as a synonym for “good” or “scientific,” both to support and refute the value of complementary medicine practices. [1] But EBM takes a narrow view of what constitutes “good” evidence, and it excludes important qualitative and observational information about the use and benefits of complementary medicine.

The key idea of EBM is a “hierarchy of evidence” (figure 1). In this hierarchy, information from systematic reviews of randomized controlled trials is the “best” evidence, followed by individual randomized controlled trials, then by nonrandomized trials, observational studies, and finally case-series. [2] When the evidence of what type of medicine works and what type does not is synthesized, the type of emphasis is at the top of the pyramid, and the evidence that is considered inferior is at the lower levels. Clinical experiments that isolate a causal and additive link between a specific intervention and a specific clinical outcome are seen as the “gold standard” in this evidence model.

Figure 1: The traditional hierarchy of evidence is narrow

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Spinal Manipulation and Exercise for Low Back Painin Adolescents: Study Protocol for a Randomized Controlled Trial

By Frank M. Painter|June 1, 2014|Chiropractic Care, Low Back Pain, Pediatrics|

Spinal Manipulation and Exercise for Low Back Pain in Adolescents: Study Protocol for a Randomized Controlled Trial

The Chiro.Org Blog

SOURCE: Chiropractic & Manual Therapies 2014 (May 23); 22: 21 ~ FULL TEXT

Craig Schulz, Brent Leininger, Roni Evans, Darcy Vavrek, Dave Peterson, Mitchell Haas

and Gert Bronfort

Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences
University, 2501 W 84th St, Bloomington, MN 55431, USA

Background Low back pain is among the most common and costly chronic health care conditions. Recent research has highlighted the common occurrence of non-specific low back pain in adolescents, with prevalence estimates similar to adults. While multiple clinical trials have examined the effectiveness of commonly used therapies for the management of low back pain in adults, few trials have addressed the condition in adolescents. The purpose of this paper is to describe the methodology of a randomized clinical trial examining the effectiveness of exercise with and without spinal manipulative therapy for chronic or recurrent low back pain in adolescents.

Methods This study is a randomized controlled trial comparing twelve weeks of exercise therapy combined with spinal manipulation to exercise therapy alone. Beginning in March 2010, a total of 184 participants, ages 12 to 18, with chronic or recurrent low back pain are enrolled across two sites. The primary outcome is self-reported low back pain intensity. Other outcomes include disability, quality of life, improvement, satisfaction, activity level, low back strength, endurance, and motion. Qualitative interviews are conducted to evaluate participants’ perceptions of treatment.

Discussion This is the first randomized clinical trial assessing the effectiveness of combining spinal manipulative therapy with exercise for adolescents with low back pain. The results of this study will provide important evidence on the role of these conservative treatments for the management of low back pain in adolescents.

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Chiropractic Care for Pediatric and Adolescent Attention-Deficit/Hyperactivity Disorder: A Systematic Review

By Frank M. Painter|May 30, 2014|Attention Deficit, Chiropractic Care|

Chiropractic Care for Pediatric and Adolescent Attention-Deficit/Hyperactivity Disorder: A Systematic Review

The Chiro.Org Blog

SOURCE: Chiropractic & Osteopathy 2010 (Jun 2); 18: 13 ~ FULL TEXT

Fay Karpouzis, Rod Bonello, and Henry Pollard

Department of Chiropractic,
Faculty of Science,
Macquarie University, Sydney, NSW 2109, Australia.
faykchiro@optusnet.com.au

Background Psychostimulants are first line of therapy for pediatric and adolescent AD/HD. The evidence suggests that up to 30% of those prescribed stimulant medications do not show clinically significant outcomes. In addition, many children and adolescents experience side-effects from these medications. As a result, parents are seeking alternate interventions for their children. Complementary and alternative medicine therapies for behavioural disorders such as AD/HD are increasing with as many as 68% of parents having sought help from alternative practitioners, including chiropractors.

Objective The review seeks to answer the question of whether chiropractic care can reduce symptoms of inattention, impulsivity and hyperactivity for pediatric and adolescent AD/HD.

Methods Electronic databases (Cochrane CENTRAL register of Controlled Trials, Cochrane Database of Systematic reviews, MEDLINE, PsycINFO, CINAHL, Scopus, ISI Web of Science, Index to Chiropractic Literature) were searched from inception until July 2009 for English language studies for chiropractic care and AD/HD. Inclusion and exclusion criteria were applied to select studies. All randomised controlled trials were evaluated using the Jadad score and a checklist developed from the CONSORT (Consolidated Standards of Reporting Trials) guidelines.

Results The search yielded 58 citations of which 22 were intervention studies. Of these, only three studies were identified for pediatric and adolescent AD/HD cohorts. The methodological quality was poor and none of the studies qualified using inclusion criteria.

Conclusions To date there is insufficient evidence to evaluate the efficacy of chiropractic care for pediatric and adolescent AD/HD. The claim that chiropractic care improves pediatric and adolescent AD/HD, is only supported by low levels of scientific evidence. In the interest of pediatric and adolescent health, if chiropractic care for AD/HD is to continue, more rigorous scientific research needs to be undertaken to examine the efficacy and effectiveness of chiropractic treatment. Adequately-sized RCTs using clinically relevant outcomes and standardised measures to examine the effectiveness of chiropractic care verses no-treatment/placebo control or standard care (pharmacological and psychosocial care) are needed to determine whether chiropractic care is an effective alternative intervention for pediatric and adolescent AD/HD.

From the FULL TEXT Article:

Background

Attention-Deficit/Hyperactivity Disorder (AD/HD) is considered to be one of the most frequently diagnosed disruptive behaviour disorders in childhood [1-5], with world wide prevalence rates of 8-12%. [6] The American prevalence rates range between 3-7% [1], and 4-12%. [7] The Australian prevalence rates show 11% of 6-17 year olds are diagnosed with this disorder [8], where as the English and Welsh AD/HD prevalence rates find 5% of 6-16 year olds have the disorder. [9] The Diagnostic and Statistical Manual of Mental Disorders 4th Edition Text Revision (DSM-IV-TR) [1], is the most widely used classification system for mental disorders. [10, 11] The DSM-IV-TR characterises AD/HD as inappropriate, chronic levels of inattention, hyperactivity and impulsivity. [1] These children continually experience difficulties in academic achievement, and behavioural control, and as a consequence, they have difficulty in establishing positive relationships with family, authority figures and their peers. [12-14] As a result, much attention has been devoted to the development and evaluation of assessment and treatment for this disorder over the last fifty years. [2, 15-17] The majority of the AD/HD literature is dedicated to the treatment of this disorder. [2, 15-18] Most of this research can be found in the area of pharmacological therapies [12, 16, 17], with less emphasis in psychotherapy and other psychosocial interventions. [19] There is even less research in the area of AD/HD and complementary and alternative medicine (CAM) therapies. [20, 21]

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