Adverse Events

Association Between Chiropractic Spinal Manipulation for Sciatica and Opioid-related Adverse Events: A Retrospective Cohort Study

By Frank M. Painter|January 31, 2025|Adverse Drug Reactions, Adverse Events, Chiropractic Management, Low Back Pain, Opioid Epidemic, Sciatica|

Association Between Chiropractic Spinal Manipulation for Sciatica and Opioid-related Adverse Events: A Retrospective Cohort Study

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SOURCE: PLoS One 2025 (Jan 28); 20 (1): e0317663

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Robert J. Trager • Zachary A. Cupler • Roshini Srinivasan • Elleson G. Harper • Jaime A. Perez

Connor Whole Health,
University Hospitals Cleveland Medical Center,
Cleveland, Ohio, United States of America.

Background: Patients receiving chiropractic spinal manipulation (CSM) for spinal pain are less likely to be prescribed opioids, and some evidence suggests that these patients have a lower risk of any type of adverse drug event. We hypothesize that adults receiving CSM for sciatica will have a reduced risk of opioid-related adverse drug events (ORADEs) over a one-year follow-up compared to matched controls not receiving CSM.

Methods: We searched a United States (US) claims-based data resource (Diamond Network, TriNetX, Inc.) of more than 216 million patients, yielding data ranging from 2009 to 2024. We included patients aged ?18 years with sciatica, excluding those post-spine surgery, prior anesthesia, serious pathology, high risk of ORADEs, and an ORADE ? 1-year prior. Patients were divided into two cohorts: (1) CSM and (2) usual medical care. We used propensity score matching to control for confounding variables associated with ORADEs. Comparative outcomes were analyzed by calculating risk ratios (RRs) and 95% confidence intervals (CIs) for the incidence of ORADEs and oral opioid prescription between cohorts.

Results: 372,471 patients per cohort remained after matching. The incidence of ORADEs over 1-year follow-up was less in the CSM cohort compared to the usual medical care cohort (CSM: 0.09%; usual medical care: 0.30%), yielding an RR of 0.29 (95% CI: 0.25-0.32; P < .00001). CSM patients had a lower risk of receiving an oral opioid prescription (RR of 0.68 [95% CI: 0.68-0.69; P < .00001]).

Conclusions: This study found that adults with sciatica who initially received CSM had a lower risk of an ORADE compared to matched controls not initially receiving CSM, likely explained by a lower probability of opioid prescription. These findings corroborate existing practice guidelines which recommend adding CSM to the management of sciatica when appropriately indicated.

From the FULL TEXT Article:

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A Retrospective Analysis of the Incidence of Severe Adverse Events Among Recipients of Chiropractic Spinal Manipulative Therapy

By Frank M. Painter|June 24, 2024|Adverse Events, Spinal Manipulation|

A Retrospective Analysis of the Incidence of Severe Adverse Events Among Recipients of Chiropractic Spinal Manipulative Therapy

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SOURCE: Sci Rep 2023 (Jan 23); 13 (1): 1254

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Eric Chun-Pu Chu • Robert J Trager
Linda Yin-King Lee • Imran Khan Niazi

New York Chiropractic and Physiotherapy Centre,
EC Healthcare, 41/F Langham Place Office Tower,
8 Argyle Street, Kowloon, Hong Kong.

This study examined the incidence and severity of adverse events (AEs) of patients receiving chiropractic spinal manipulative therapy (SMT), with the hypothesis that < 1 per 100,000 SMT sessions results in a grade ≥ 3 (severe) AE. A secondary objective was to examine independent predictors of grade ≥ 3 AEs. We identified patients with SMT-related AEs from January 2017 through August 2022 across 30 chiropractic clinics in Hong Kong. AE data were extracted from a complaint log, including solicited patient surveys, complaints, and clinician reports, and corroborated by medical records. AEs were independently graded 1–5 based on severity (1–mild, 2–moderate, 3–severe, 4–life-threatening, 5–death). Among 960,140 SMT sessions for 54,846 patients, 39 AEs were identified, two were grade 3, both of which were rib fractures occurring in women age > 60 with osteoporosis, while none were grade ≥ 4, yielding an incidence of grade ≥ 3 AEs of 0.21 per 100,000 SMT sessions (95% CI 0.00, 0.56 per 100,000). There were no AEs related to stroke or cauda equina syndrome. The sample size was insufficient to identify predictors of grade ≥ 3 AEs using multiple logistic regression. In this study, severe SMT-related AEs were reassuringly very rare.

Subject terms: Adverse effects, Rehabilitation

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Benefits and Harms of Spinal Manipulative Therapy

By Frank M. Painter|February 28, 2020|Adverse Events|

Benefits and Harms of Spinal Manipulative Therapy for the Treatment of Chronic Low Back Pain: Systematic Review and Meta-analysis of Randomised Controlled Trials

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SOURCE: British Medical Journal 2019 (Mar 13)

Sidney M Rubinstein, Annemarie de Zoete, Marienke van Middelkoop, Willem J J Assendelft, Michiel R de Boer, and Maurits W van Tulder

Department of Health Sciences,
Faculty of Science,
Vrije Universiteit Amsterdam,
De Boelelaan 1085, 1081HV
Amsterdam, Netherlands

OBJECTIVE: To assess the benefits and harms of spinal manipulative therapy (SMT) for the treatment of chronic low back pain.

DESIGN: Systematic review and meta-analysis of randomised controlled trials.

DATA SOURCES: Medline, PubMed, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), CINAHL, Physiotherapy Evidence Database (PEDro), Index to Chiropractic Literature, and trial registries up to 4 May 2018, including reference lists of eligible trials and related reviews.

ELIGIBILITY CRITERIA FOR SELECTING STUDIES: Randomised controlled trials examining the effect of spinal manipulation or mobilisation in adults (≥18 years) with chronic low back pain with or without referred pain. Studies that exclusively examined sciatica were excluded, as was grey literature. No restrictions were applied to language or setting.

REVIEW METHODS: Two reviewers independently selected studies, extracted data, and assessed risk of bias and quality of the evidence.

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Tissue Loading Created During Spinal Manipulation

By Frank M. Painter|October 24, 2017|Adverse Events, Disc Derangement|

Tissue Loading Created During Spinal Manipulation in Comparison to Loading Created by Passive Spinal Movements

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SOURCE: Sci Rep. 2016 (Dec 1); 6: 38107

Martha Funabashi, Gregory N. Kawchuk, Albert H. Vette,
Peter Goldsmith, and Narasimha Prasad

Department of Physical Therapy,
University of Alberta,
Edmonton, AB, Canada

Spinal manipulative therapy (SMT) creates health benefits for some while for others, no benefit or even adverse events. Understanding these differential responses is important to optimize patient care and safety. Toward this, characterizing how loads created by SMT relate to those created by typical motions is fundamental. Using robotic testing, it is now possible to make these comparisons to determine if SMT generates unique loading scenarios. In 12 porcine cadavers, SMT and passive motions were applied to the L3/L4 segment and the resulting kinematics tracked. The L3/L4 segment was removed, mounted in a parallel robot and kinematics of SMT and passive movements replayed robotically. The resulting forces experienced by L3/L4 were collected. Overall, SMT created both significantly greater and smaller loads compared to passive motions, with SMT generating greater anterioposterior peak force (the direction of force application) compared to all passive motions. In some comparisons, SMT did not create significantly different loads in the intact specimen, but did so in specific spinal tissues. Despite methodological differences between studies, SMT forces and loading rates fell below published injury values. Future studies are warranted to understand if loading scenarios unique to SMT confer its differential therapeutic effects.

From the FULL TEXT Article:

Introduction

Spinal manipulative therapy (SMT) is a clinical intervention for low back pain which, by some estimates, is the most frequently used form of complementary and alternative medicine (CAM). [1] Similarly, SMT is also one of the most studied CAM interventions with over 250 systematic reviews and 550 randomized controlled trials since 2000.

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Outcomes Of Pregnant Patients With Low Back Pain Undergoing Chiropractic Treatment

By Frank M. Painter|August 9, 2016|Adverse Events, Pediatrics|

Outcomes Of Pregnant Patients With Low Back Pain Undergoing Chiropractic Treatment: A Prospective Cohort Study With Short Term, Medium Term and 1 Year Follow-up

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SOURCE: Chiropractic & Manual Therapies 2014 (Apr 1); 22 (1): 15

Cynthia K Peterson, Daniel Mühlemann, Barry Kim Humphreys

Department of Chiropractic Medicine,
Orthopaedic University Hospital Balgrist,

University of Zürich,
Forchstrasse 340,
Zürich, Switzerland

This study, from the chiropractic researchers at the University of Zurich in Switzerland, demonstrates that chiropractic care helps reduce low back pain during pregnancy, and another study by this same group demonstrates the long-term benefits from chiropractic adjustments for lumbar disc herniations.

BACKGROUND: Low back pain in pregnancy is common and research evidence on the response to chiropractic treatment is limited.

The purposes of this study are

1) to report outcomes in pregnant patients receiving chiropractic treatment

2) to compare outcomes from subgroups

3) to assess predictors of outcome.

METHODS: Pregnant patients with low back or pelvic pain, no contraindications to manipulative therapy and no manual therapy in the prior 3 months were recruited.Baseline numerical rating scale (NRS) and Oswestry questionnaire data were collected. Duration of complaint, number of previous LBP episodes, LBP during a previous pregnancy, and category of pain location were recorded.The patient’s global impression of change (PGIC) (primary outcome), NRS, and Oswestry data (secondary outcomes) were collected at 1 week, 1 and 3 months after the first treatment. At 6 months and 1 year the PGIC and NRS scores were collected. PGIC responses of ‘better or ‘much better’ were categorized as ‘improved’.The proportion of patients ‘improved’ at each time point was calculated. Chi-squared test compared subgroups with ‘improvement’. Baseline and follow-up NRS and Oswestry scores were compared using the paired t-test. The unpaired t-test compared NRS and Oswestry scores in patients with and without a history of LBP and with and without LBP during a previous pregnancy. Anova compared baseline and follow-up NRS and Oswestry scores by pain location category and category of number of previous LBP episodes. Logistic regression analysis also was also performed.

RESULTS: 52% of 115 recruited patients ‘improved’ at 1 week, 70% at 1 month, 85% at 3 months, 90% at 6 months and 88% at 1 year. There were significant reductions in NRS and Oswestry scores (p < 0.0005). Category of previous LBP episodes number at one year (p = 0.02) was related to ‘improvement’ when analyzed alone, but was not strongly predictive in logistic regression. Patients with more prior LBP episodes had higher 1 year NRS scores (p = 0.013).

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The OUCH Randomized Controlled Trial of Adverse Events

By Frank M. Painter|February 25, 2016|Adverse Events, Spinal Manipulation|

Outcomes of Usual Chiropractic. The OUCH Randomized Controlled Trial of Adverse Events

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SOURCE: Spine (Phila Pa 1976). 2013 (Sep 15); 38 (20): 1723–1729

Bruce F Walker, Jeffrey J Hebert, Norman J Stomski,
Brenton R Clarke, Ross S Bowden,
Barrett Losco, Simon D French

School of Health Professions
Murdoch University,
Murdoch, Australia

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%
headache	sham 17%	usual care 9%

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