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Adverse Events

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

By |June 24, 2024|Adverse Events, Spinal Manipulation|

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

The Chiro.Org Blog

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

  OPEN ACCESS   

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 |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

The Chiro.Org Blog

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 |October 24, 2017|Adverse Events, Disc Derangement|

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

The Chiro.Org Blog

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 |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

The Chiro.Org Blog

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 |February 25, 2016|Adverse Events, Spinal Manipulation|

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

The Chiro.Org Blog

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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Clinical Outcomes and Patient Satisfaction

By |February 24, 2016|Adverse Events, Patient Satisfaction, Upper Cervical Adjusting|

Symptomatic Reactions, Clinical Outcomes and Patient Satisfaction Associated with
Upper Cervical Chiropractic Care: A Prospective, Multicenter, Cohort Study

The Chiro.Org Blog

SOURCE:   BMC Musculoskelet Disord. 2011 (Oct 5); 12: 219

Kirk Eriksen, Roderic P Rochester, and Eric L Hurwitz

Chiropractic Health Institute, PC
2500 Flowers Chapel Road
Dothan, AL 36305, USA.

 

BACKGROUND:   Observational studies have previously shown that adverse events following manipulation to the neck and/or back are relatively common, although these reactions tend to be mild in intensity and self-limiting. However, no prospective study has examined the incidence of adverse reactions following spinal adjustments using upper cervical techniques, and the impact of this care on clinical outcomes.

METHODS:   Consecutive new patients from the offices of 83 chiropractors were recruited for this practice-based study. Clinical outcome measures included:
1) Neck pain disability index (100-point scale),
2) Oswestry back pain index (100-point scale),
3) 11-point numerical rating scale (NRS) for neck, headache, midback, and low back pain,
4) treatment satisfaction, and
5) Symptomatic Reactions (SR).

Data were collected at baseline, and after approximately 2 weeks of care. A patient reaching sub-clinical status for pain and disability was defined as a follow-up score <3 NRS and <10%, respectively. A SR is defined as a new complaint not present at baseline or a worsening of the presenting complaint by >30% based on an 11-point numeric rating scale occurring <24 hours after any upper cervical procedure.

RESULTS:   A total of 1,090 patients completed the study having 4,920 (4.5 per patient) office visits requiring 2,653 (2.4 per patient) upper cervical adjustments over 17 days. Three hundred thirty- eight (31.0%) patients had symptomatic reactions (SRs) meeting the accepted definition. Intense SR (NRS ≥8) occurred in 56 patients (5.1%). Outcome assessments were significantly improved for neck pain and disability, headache, mid-back pain, as well as lower back pain and disability (p <0.001) following care with a high level (mean = 9.1/10) of patient satisfaction. The 83 chiropractors administered >5 million career upper cervical adjustments without a reported incidence of serious adverse event.

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