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Imperfect Placebos Are Common In Low Back Pain Trials: A Systematic Review Of The Literature

By Frank M. Painter|October 20, 2016|Placebo|

Imperfect Placebos Are Common In Low Back Pain Trials: A Systematic Review Of The Literature

SOURCE: Eur Spine J. 2008 (Jul); 17 (7): 889–904

L. A. C. Machado, S. J. Kamper, R. D. Herbert,
G. Maher, and J. H. McAuley

Back Pain Research Group,
Musculoskeletal Division,
The George Institute for International Health,
Missenden Rd, P.O. Box M201,
Camperdown, NSW, 2050, Australia.

The placebo is an important tool to blind patients to treatment allocation and therefore minimise some sources of bias in clinical trials. However, placebos that are improperly designed or implemented may introduce bias into trials. The purpose of this systematic review was to evaluate the adequacy of placebo interventions used in low back pain trials. Electronic databases were searched systematically for randomised placebo-controlled trials of conservative interventions for low back pain. Trial selection and data extraction were performed by two reviewers independently. A total of 126 trials using over 25 different placebo interventions were included. The strategy most commonly used to enhance blinding was the provision of structurally equivalent placebos. Adequacy of blinding was assessed in only 13% of trials. In 20% of trials the placebo intervention was a potentially genuine treatment. Most trials that assessed patients’ expectations showed that the placebo generated lower expectations than the experimental intervention.

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Placebo Effects In Trials Evaluating 12 Selected Minimally Invasive Interventions

By Frank M. Painter|October 19, 2016|Placebo|

Placebo Effects In Trials Evaluating 12 Selected Minimally Invasive Interventions: A Systematic Review And Meta-Analysis

The Chiro.Org Blog

SOURCE: BMJ Open. 2015 (Jan 30); 5 (1): e007331

Robin Holtedahl, Jens Ivar Brox, Ole Tjomsland

Department of Physical Medicine and Rehabilitation,
Oslo University Hospital,
Oslo, Norway.

OBJECTIVES: To analyse the impact of placebo effects on outcome in trials of selected minimally invasive procedures and to assess reported adverse events in both trial arms.

DESIGN: A systematic review and meta-analysis.

DATA SOURCES AND STUDY SELECTION: We searched MEDLINE and Cochrane library to identify systematic reviews of musculoskeletal, neurological and cardiac conditions published between January 2009 and January 2014 comparing selected minimally invasive with placebo (sham) procedures. We searched MEDLINE for additional randomised controlled trials published between January 2000 and January 2014.

DATA SYNTHESIS: Effect sizes (ES) in the active and placebo arms in the trials’ primary and pooled secondary end points were calculated. Linear regression was used to analyse the association between end points in the active and sham groups. Reported adverse events in both trial arms were registered.

RESULTS: We included 21 trials involving 2,519 adult participants. For primary end points, there was a large clinical effect (ES≥0.8) after active treatment in 12 trials and after sham procedures in 11 trials. For secondary end points, 7 and 5 trials showed a large clinical effect. Three trials showed a moderate difference in ES between active treatment and sham on primary end points (ES ≥0.5) but no trials reported a large difference. No trials showed large or moderate differences in ES on pooled secondary end points. Regression analysis of end points in active treatment and sham arms estimated an R(2) of 0.78 for primary and 0.84 for secondary end points. Adverse events after sham were in most cases minor and of short duration.

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Identification Of Subgroups Of Inflammatory And Degenerative MRI Findings In The Spine And Sacroiliac Joints:

By Frank M. Painter|October 18, 2016|Low Back Pain|

Identification Of Subgroups Of Inflammatory And Degenerative MRI Findings In The Spine And Sacroiliac Joints: A Latent Class Analysis Of 1037 Patients With Persistent Low Back Pain

The Chiro.Org Blog

SOURCE: Arthritis Res Ther. 2016 (Oct 13); 18 (1): 237

Bodil Arnbak, Rikke Krüger Jensen, Claus Manniche,
Oliver Hendricks, Peter Kent, Anne Grethe Jurik
and Tue Secher Jensen

Research Department,
Spine Centre of Southern Denmark,
Hospital Lillebaelt,
Oestre Hougvej 55, Middelfart, 5500, Denmark.
bodil.arnbak@rsyd.dk

BACKGROUND: &nbsp The aim of this study was to investigate subgroups of magnetic resonance imaging (MRI) findings for the spine and sacroiliac joints (SIJs) using latent class analysis (LCA), and to investigate whether these subgroups differ in their demographic and clinical characteristics.

METHODS: &nbsp The sample included 1037 patients aged 18—40 years with persistent low back pain (LBP). LCA was applied to MRI findings of the spine and SIJs. The resulting subgroups were tested for differences in self-reported demographic and clinical characteristics.

RESULTS: &nbsp A five-class model was identified: Subgroup 1, ‘No or few findings’ (n = 116); Subgroup 2, ‘Mild spinal degeneration’ (n = 540); Subgroup 3, ‘Moderate to severe spinal degeneration’ (n = 229); Subgroup 4, ‘Moderate to severe spinal degeneration with mild SIJ findings’ (n = 68); and Subgroup 5, ‘Mild spinal degeneration with moderate to severe SIJ findings’ (n = 84). The two SIJ subgroups (Subgroups 4 and 5) had a higher median activity limitation score (Roland Morris Disability Questionnaire calculated as a proportional score: 65 (IQR 48—78)/65 (48—78)) compared with Subgroups 1—3 (48 (35—74)/57 (39—74)/57 (39—74)), a higher prevalence of women (68% (95% CI 56—79)/68% (58—78)) compared with Subgroups 2 and 3 (51% (47—55)/40% (33—46)), a higher prevalence of being overweight (67% (95% CI 55—79)/53% (41—65)) compared with Subgroup 1 (36% (26—46)) and a higher prevalence of previous LBP episodes (yes/no: 81% (95% CI 71—91)/79% (70—89)) compared with Subgroup 1 (58% (48—67)). Subgroup 5 was younger than Subgroup 4 (median age 29 years (IQR 25—33) versus 34 years (30—37)) and had a higher prevalence of HLA—B27 (40% (95% CI 29—50)) compared with the other subgroups (Subgroups 1—4: 12% (6—18)/7% (5—10)/6% (3—9)/12% (4—20)). Across the subgroups with predominantly spinal findings (Subgroups 1—3), median age, prevalence of men, being overweight and previous LBP episodes were statistically significantly lower in Subgroup 1, higher in Subgroup 2 and highest in Subgroup 3.

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Chiropractic Spinal Manipulative Therapy For Migraine:
A Three-Armed, Single-Blinded, Placebo, Randomized Controlled Trial

By Frank M. Painter|October 14, 2016|Migraine|

Chiropractic Spinal Manipulative Therapy For Migraine: A Three-Armed, Single-Blinded, Placebo, Randomized Controlled Trial

The Chiro.Org Blog

SOURCE: Eur J Neurol. 2016 (Oct 2) [Epub]

Aleksander Chaibi, Jurate Šaltyte Benth, Peter J Tuchin, Michael Bjørn Russell

Head and Neck Research Group,
Akershus University Hospital,
Lørenskog, Norway.

BACKGROUND AND PURPOSE: To investigate the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs.

METHODS: This was a prospective three-armed, single-blinded, placebo, randomized controlled trial (RCT) of 17 months duration including 104 migraineurs with at least one migraine attack per month. The RCT was conducted at Akershus University Hospital, Oslo, Norway. Active treatment consisted of CSMT, whereas placebo was a sham push manoeuvre of the lateral edge of the scapula and/or the gluteal region. The control group continued their usual pharmacological management. The RCT consisted of a 1-month run-in, 3 months intervention and outcome measures at the end of the intervention and at 3, 6 and 12 months follow-up. The primary end-point was the number of migraine days per month, whereas secondary end-points were migraine duration, migraine intensity and headache index, and medicine consumption.

RESULTS: Migraine days were significantly reduced within all three groups from baseline to post-treatment (P < 0.001). The effect continued in the CSMT and placebo group at all follow-up time points, whereas the control group returned to baseline. The reduction in migraine days was not significantly different between the groups (P > 0.025 for interaction). Migraine duration and headache index were reduced significantly more in the CSMT than the control group towards the end of follow-up (P = 0.02 and P = 0.04 for interaction, respectively). Adverse events were few, mild and transient. Blinding was strongly sustained throughout the RCT.

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Preliminary Study Into The Components Of TheFear-Avoidance Model

By Frank M. Painter|October 5, 2016|Biopsychosocial Model|

Preliminary Study Into The Components of the Fear-Avoidance Model Of LBP:
Change After An Initial Chiropractic Visit And Influence On Outcome

The Chiro.Org Blog

SOURCE: Chiropractic & Osteopathy 2010 (Jul 30); 18: 21

Jonathan R Field, Dave Newell, and Peter W McCarthy

Back2Health,
2 Charles Street,
Petersfield, Hants, GU32 3EH, UK.
jonathanfield@me.com

BACKGROUND: In the last decade the sub grouping of low back pain (LBP) patients according to their likely response to treatment has been identified as a research priority. As with other patient groups, researchers have found few if any factors from the case history or physical examination that are helpful in predicting the outcome of chiropractic care. However, in the wider LBP population psychosocial factors have been identified that are significantly prognostic. This study investigated changes in the components of the LBP fear-avoidance beliefs model in patients pre- and post- their initial visit with a chiropractor to determine if there was a relationship with outcomes at 1 month.

METHODS: Seventy one new patients with lower back pain as their primary complaint presenting for chiropractic care to one of five clinics (nine chiropractors) completed questionnaires before their initial visit (pre-visit) and again just before their second appointment (post-visit). One month after the initial consultation, patient global impression of change (PGIC) scores were collected. Pre visit and post visit psychological domain scores were analysed for any association with outcomes at 1 month.

RESULTS: Group mean scores for Fear Avoidance Beliefs (FAB), catastrophisation and self-efficacy were all improved significantly within a few days of a patient’s initial chiropractic consultation. Pre-visit catastrophisation as well as post-visit scores for catastrophisation, back beliefs (inevitability) and self-efficacy were weakly correlated with patient’s global impression of change (PGIC) at 1 month. However when the four assessed psychological variables were dichotomised about pre-visit group medians those individuals with 2 or more high variables post-visit had a substantially increased risk (OR 36.4 (95% CI 6.2-213.0) of poor recovery at 1 month. Seven percent of patients with 1 or fewer adverse psychological variables described poor benefit compared to 73% of those with 2 or more.

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The Physiological Role of Tumor Necrosis Factor in Human Immunity and Its Potential Implications in Spinal Manipulative Therapy

By Frank M. Painter|October 1, 2016|Immune Function, Spinal Manipulation|

The Physiological Role of Tumor Necrosis Factor in Human Immunity and Its Potential

Implications in Spinal Manipulative Therapy: A Narrative Literature Review

The Chiro.Org Blog

SOURCE: J Chiropractic Medicine 2016 (Sep)

Liang Zhang, MD, PhD, Chao Hua Yao, MD

Palmer College of Chiropractic,
Florida Campus, Port Orange, FL;
Palmer Laboratory of Cell & Molecular Biology,
Palmer Center for Chiropractic Research,
Port Orange, FL.

OBJECTIVE: Although tumor necrosis factor (TNF) is a well-known inflammatory cytokine in the pathological development of various human diseases, its physiological roles are not widely understood nor appreciated. The molecular mechanisms underlying spinal manipulation therapy (SMT) remain elusive. The relationship between TNF and SMT is unclear. Thus, we performed this literature review to better understand TNF physiology and its potential relationship with SMT, and we propose a novel mechanism by which SMT may achieve clinical benefits by using certain beneficial features of TNF.

METHODS: We searched several databases for relevant articles published between 1975 and 2015 and then reexamined the studies from current immunophysiological perspectives.

RESULTS: The history and recent progresses in TNF physiology research were explored. Conflicting reports on the relationship between TNF and SMT were identified. Based on the newly discovered interaction between TNF and regulatory T cells, we proposed a putative biphasic TNF response to SMT, which may resolve the conflicts in the reported observations and interpretations.

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Imperfect Placebos Are Common In Low Back Pain Trials: A Systematic Review Of The Literature

Imperfect Placebos Are Common In Low Back Pain Trials: A Systematic Review Of The Literature

Placebo Effects In Trials Evaluating 12 Selected Minimally Invasive Interventions

Placebo Effects In Trials Evaluating 12 Selected Minimally Invasive Interventions: A Systematic Review And Meta-Analysis

Identification Of Subgroups Of Inflammatory And Degenerative MRI Findings In The Spine And Sacroiliac Joints:

Identification Of Subgroups Of Inflammatory And Degenerative MRI Findings In The Spine And Sacroiliac Joints: A Latent Class Analysis Of 1037 Patients With Persistent Low Back Pain

Chiropractic Spinal Manipulative Therapy For Migraine:A Three-Armed, Single-Blinded, Placebo, Randomized Controlled Trial

Chiropractic Spinal Manipulative Therapy For Migraine: A Three-Armed, Single-Blinded, Placebo, Randomized Controlled Trial

Preliminary Study Into The Components Of TheFear-Avoidance Model

Preliminary Study Into The Components of the Fear-Avoidance Model Of LBP: Change After An Initial Chiropractic Visit And Influence On Outcome

The Physiological Role of Tumor Necrosis Factor in Human Immunity and Its Potential Implications in Spinal Manipulative Therapy

The Physiological Role of Tumor Necrosis Factor in Human Immunity and Its Potential

Implications in Spinal Manipulative Therapy: A Narrative Literature Review

Chiropractic Spinal Manipulative Therapy For Migraine:
A Three-Armed, Single-Blinded, Placebo, Randomized Controlled Trial

Preliminary Study Into The Components of the Fear-Avoidance Model Of LBP:
Change After An Initial Chiropractic Visit And Influence On Outcome