Craig Schulz, Roni Evans, Michele Maiers, Karen Schulz, Brent Leininger and Gert Bronfort
University of Minnesota,
Mayo Building C504,
420 Delaware Street SE,
Minneapolis, MN 55455, USA
Background Low back pain (LBP) is a common disabling condition in older adults which often limits physical function and diminishes quality of life. Two clinical trials in older adults have shown spinal manipulative therapy (SMT) results in similar or small improvements relative to medical care; however, the effectiveness of adding SMT or rehabilitative exercise to home exercise is unclear.
Methods We conducted a randomized clinical trial assessing the comparative effectiveness of adding SMT or supervised rehabilitative exercise to home exercise in adults 65 or older with sub-acute or chronic LBP. Treatments were provided over 12–weeks and self-report outcomes were collected at 4, 12, 26, and 52 weeks. The primary outcome was pain severity. Secondary outcomes included back disability, health status, medication use, satisfaction with care, and global improvement. Linear mixed models were used to analyze outcomes. The primary analysis included longitudinal outcomes in the short (week 4–12) and long-term (week 4–52). An omnibus test assessing differences across all groups over the year was used to control for multiplicity. Secondary analyses included outcomes at each time point and responder analyses. This study was funded by the US Department of Health and Human Services, Health Resources and Services Administration.
Results 241 participants were randomized and 230 (95%) provided complete primary outcome data. The primary analysis showed group differences in pain over the one-year were small and not statistically significant. Pain severity was reduced by 30 to 40% after treatment in all 3 groups with the largest difference (eight percentage points) favoring SMT and home exercise over home exercise alone. Group differences at other time points ranged from 0 to 6 percentage points with no consistent pattern favoring one treatment. One-year post-treatment pain reductions diminished in all three groups. Secondary self-report outcomes followed a similar pattern with no important group differences, except satisfaction with care, where the two combination groups were consistently superior to home exercise alone.
University of Turin Medical School,
I have been fascinated with placebo-controlled trials since the 90s. In those days, virtually all the placebo-controlled manipulative trials claimed that SMT was *no better than placebo*. And in those days, medicine looked down their long noses, considering placebo as worthless, a mild side-effect of trickery and quackery.
“A patient finally went to a chiropractor for her back pain after finding no relief with the orthopedist. After three adjustments and a week of no symptoms, she had a follow-up visit with her M.D.
Upon learning about the success of the D.C., the orthopedist stated, “That was just the placebo effect.”
The patient responded, “If it works so well, why didn’t you use it?”
–– Attributed to Robert Mootz, D.C.
Finally, I got around to copying several of those early SMT/placebo studies, and was pleasantly shocked to discover that, compared to pre-study findings, BOTH groups improved significantly. This did NOT mean SMT didn’t help patients, it just means that it didn’t help them MORE than the pacebo did. It also strongly suggested that the plazcebo(s) were probably NOT inert.
At any rate, now you know why I started collecrting articles on placebo, and they eventually coalesced (2002) into our topical Problem with Placebos/Shams Page. This is how many of our other topical pages evolved from their humble beginnings.
Clinical trials use placebos with the assumption that they are inert, thus all placebos are considered to be equal. Here we show that this assumption is wrong and that different placebo procedures are associated to different therapeutic rituals which, in turn, trigger different mechanisms and produce different therapeutic outcomes. We studied high altitude, or hypobaric hypoxia, headache, in which two different placebos were administered. The first was placebo oxygen inhaled through a mask, whereas the second was placebo aspirin swallowed with a pill.
Michele Sterling, James M. Elliott, and Peter J. Cabot
Centre of National Research on Disability and Rehabilitation Medicine (CONROD),
The University of Queensland, Brisbane,
Tissue damage or pathological alterations are not detectable in the majority of people with whiplash associated disorders (WAD). Widespread hyperalgisa, morphological muscle changes and psychological distress are common features of WAD. However little is known about the presence of inflammation and its association with symptom persistence or the clinical presentation of WAD. This study aimed to prospectively investigate changes in serum inflammatory biomarker levels from the acute (<3 weeks) to chronic (>3 months) stages of whiplash injury.
It also aimed to determine relationships between biomarker levels and hyperalgesia, fatty muscle infiltrates of the cervical extensors identified on MRI and psychological factors. 40 volunteers with acute WAD and 18 healthy controls participated. Participants with WAD were classified at 3 months as recovered/mild disability or having moderate/severe disability using the Neck Disability Index. At baseline both WAD groups showed elevated serum levels of C-reactive protein (CRP) but by 3 months levels remained elevated only in the moderate/severe group.
The recovered/mild disability WAD group had higher levels of TNF-α at both time points than both the moderate/severe WAD group and healthy controls. There were no differences found in serum IL-1β. Moderate relationships were found between hyperalgesia and CRP at both time points and between hyperalgesia and IL-1β 3 months post injury. There was a moderate negative correlation between TNF-α and amount of fatty muscle infiltrate and pain intensity at 3 months.
Only a weak relationship was found between CRP and pain catastrophising and no relationship between biomarker levels and posttraumatic stress symptoms. The results of the study indicate that inflammatory biomarkers may play a role in outcomes following whiplash injury as well as being associated with hyperalgesia and fatty muscle infiltrate in the cervical extensors.
James M. Elliott, PhD, PT, D. Mark Courtney, MD, Alfred Rademaker, PhD, Daniel Pinto, PhD, PT, Michele M. Sterling, PhD, PT, and Todd B. Parrish, PhD
Department of Physical Therapy and Human Movement Sciences,
Feinberg School of Medicine,
STUDY DESIGN: Single-center prospective longitudinal study.
OBJECTIVE: To study the (1) temporal development of muscle fatty infiltrates (MFI) in the cervical multifidi after whiplash, (2) differences in multifidi MFI between those who recover or report milder pain-related disability and those who report moderate/severe symptoms at 3 months, and (3) predictive value of multifidi MFI outcomes.
SUMMARY OF BACKGROUND DATA: The temporal development of MFI on conventional magnetic resonance image has been shown to be associated with specific aspects of pain and psychological factors. The replication of such findings has yet to be explored longitudinally.
METHODS: Thirty-six subjects with whiplash injury were enrolled at less than 1 week postinjury and classified at 3 months using percentage scores on the Neck Disability Index as recovered/mild (0%–28%) or severe (≥30%). A fat/water magnetic resonance imaging measure, patient self-report of pain-related disability, and post-traumatic stress disorder were collected at less than 1 week, 2 weeks, and 3 months postinjury. The effects of time and group (per Neck Disability Index) and the interaction of time by group on MFI were determined. Receiver operating characteristic curve analysis was used to determine a cut-point for MFI at 2 weeks to predict outcome at 3 months.
RESULTS: There was no difference in MFI across groups at enrolment. MFI values were significantly higher in the severe group than those in the recovered/mild group at 2 weeks and 3 months. The receiver operating characteristic curve analysis indicated that MFI levels of 20.5% or above resulted in a sensitivity of 87.5% and a specificity of 92.9% for predicting outcome at 3 months.
Christian Manansala, DC, MSc(c), Steven Passmore, DC, PhD, Katie Pohlman, DC, PhD(c), Audrey Toth, DC, Gerald Olin, BSc, DC, CDir
Faculty of Kinesiology and Recreation Management,
University of Manitoba, Canada.
BACKGROUND: The presence of spinal pain in young people has been established as a risk factor for spinal pain later in life. Recent clinical practice guidelines recommend spinal manipulation (SM), soft tissue therapy, acupuncture, and other modalities that are common treatments provided by chiropractors, as interventions for spine pain. Less is known specifically on the response to chiropractic management in young people with spinal pain. The purpose of this manuscript was to describe the impact, through pain measures, of a pragmatic course of chiropractic management in young people’s spinal pain at a publicly funded healthcare facility for a low-income population.
METHODS: The study utilized a retrospective analysis of prospectively collected quality assurance data attained from the Mount Carmel Clinic (MCC) chiropractic program database. Formal permission to conduct the analysis of the database was acquired from the officer of records at the MCC. The University of Manitoba’s Health Research Ethics Board approved all procedures.
RESULTS: Young people (defined as 10-24 years of age) demonstrated statistically and clinically significant improvement on the numeric rating scale (NRS) in all four spinal regions following chiropractic management.