Risk and Patient Incidents

 

Risks of osteopathic treatment

 

The current evidence base for risk relating to spinal manipulation includes studies from a number of different professional disciplines (e.g. chiropractic, physiotherapy, medicine as well as osteopathy); they may have different interpretations of manipulation and perform manipulations in slightly different ways but the information from these studies is still relevant to osteopathic practice9,10,11,12.

You can go directly to each question by clicking on the links below:

 

What are the known common reactions to osteopathic treatment?

Who is most likely to experience these common reactions?

What about other, more serious treatment reactions?

How often do serious treatment reactions occur?

What can serious treatment reaction/patient incidents include?

What should I be thinking about, in terms of risk, when treating patients with neck pain?

 

 

What are the known common reactions to osteopathic treatment?

 

Reactions to any treatment can be described as positive, negative, physiological or psychological.

Approximately half of all manual therapy patients experience some mild to moderate short-lived reaction to treatment.  These can include, for example, a temporary increase in pain, aching after treatment, or post-treatment fatigue.

In a study of osteopathy patients, 10-20% patients reported an increase in pain or symptoms, however, 42% of those went on to make clinically significant improvements compared to base line9. Most muscle soreness, aching and headache post treatment resolved within 24 hours.

Many patients who attend for osteopathic treatment take non-steroidal anti-inflammatory drugs (NSAIDs) to help with their symptoms.  Approximately 1 in 10 people who take NSAIDs on a daily basis experience persistent headaches (http://www.nhs.uk/Conditions/Anti-inflammatories-non-steroidal/Pages/Side-effects.aspx).

 

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Who is most likely to experience these common reactions?

 

Mild to moderate treatment reactions are more frequently reported by females after their first appointment1.

Treatment reactions can result from a range of manual therapy techniques and an increase in intensity of symptoms does not appear to be related to high velocity thrust (HVT) techniques4.  They appear to be more common after a patient’s first treatment, and in patients presenting with multiple sites of pain4.

 

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What about other, more serious treatment reactions?

 

Symptoms that last for more than a few days that do not require medical treatment, such as increased pain or troublesome numbness or tingling are considered to be moderate treatment reactions. These types of reactions are uncommon and are estimated to occur in 1% of patients.

Reactions to treatment are serious if they require emergency medical care, or cause long term damage; they may be irreversible. Examples are stroke, nerve damage, muscular weakness, bowel and bladder weakness, or death. These would be described as a patient incident.

 

The best estimate for the frequency of patient incidents in osteopathy are 1 in 36,079 osteopathic treatments; these are not all associated with spinal manipulation4.

 

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How often do serious treatment reactions occur?

 

Treatment reactions can be experienced from any form of treatment whether that is medication, surgery, or non-invasive manual therapies like osteopathy.  The evidence that we have suggests that patient incidents do occur in manual therapy, including osteopathy, but they are very rare; the causal link is unclear also. The following table gives some best estimates for risk relating to spinal manipulation:

 

The best estimates available for serious patient incidents following manipulation are:
1 per 100,000 to 1,000,000 manipulations or 0.1 (less than one) to 1 in 100,000 manipulations1 to 10 people per 1,000,000 manipulations
1 per 50,000 to 100,000 patients 1 to 2 per 100,000 patients10 to 20 per 1,000,000 patients
Major cerebrovascular insult incidents, accidents following cervical spine manipulation:
1:120,000 – 1:1,666,666  0.06 to 0.83:100,0000.6 to 8.33:1,000,000
Lumbar disc herniation following manipulation:
1:38,013  2.63:100,00026.3:1,000,000
Cauda Equina:
<1:3.7 million – 1:100million  

 

How does this compare to the risks associated with day-to-day activities?

Stroke can occur with accidental impacts, during sport and leisure activities.

Risks in day-to-day life that could be compared with the risk of serious events following osteopathic treatment are:

 

Death from surgery to the neck 1 person in around 145 operations
Death by road traffic accident 1 person per 20,000 people in any one year
Death from long-term (years) using anti-inflammatory painkillers for osteoarthritis 1 person per 1,000 people
First time stroke 1 person per 1,000 people in the general population in any one year
Spontaneous strokes 0.03-5 person per 100,000 people in the general population over one year

 

Some patients have indicated that they don’t like this type of comparative information.  It is provided for information purposes should you require it for your patients.

 

Estimated risk of serious adverse event (death) over 1 year for: 
Non-steroidal anti-inflammatory drugs (NSAIDs for osteoarthritis) Course of manipulative treatment
1:4000 1:400,000 
The risk of having an adverse event with manual therapy (HVT) is less than taking medication (NSAIDs, diclofenac and amitriptyline)1 
 
 

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What can serious treatment reaction/patient incidents include?

 

Information gathered from the CROaM study identified a range of different treatment reactions and incidents.  These included:

  • Central neurological symptoms e.g. stroke.
  • Peripheral neurological symptoms e.g. disc prolapse and sciatic pain.
  • Non-specific musculoskeletal symptoms e.g. spasm.
  • Symptoms related to underlying pathology e.g. fracture due to undiagnosed metastases.
  • Fractures e.g. rib fracture.
  • Unallocated e.g. worsening of low back symptoms, which led to 3 days hospitalisation4.

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What should I be thinking about, in terms of risk, when treating patients with neck pain?

 

The International Federation of Orthopaedic Manipulative Physical Therapists (IFOMPT) has recently published (2012) an international framework for examination of the cervical region for potential cervical arterial dysfunction prior to orthopaedic manual therapy intervention.  A summary of this document is provided here.

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References

1. Carnes D, Mars T, Mullinger B, Underwood M. Adverse events in manual therapy: a systematic review. 2009. Available at: http://www.ncor.org.uk/wp-content/uploads/2012/10/adverse-events_in_manual_therapy_a_systematic_review_full_report.pdf

4. Vogel S, Mars T, Keeping S, Barton T, Marlin N, Froud R, Eldridge S, Underwood M, Pincus T. Clinical Risk Osteopathy and Management Scientific Report: The CROaM Study. 2013.  Available at http://www.osteopathy.org.uk/uploads/croam_full_report_0313.pdf

9. Licciardone, J., S. Stoll, et al. (2003). “Osteopathic manipulative treatment for chronic low back pain: A randomized controlled trial.” Spine 28(13): 1355-62.

10. UK BEAM Trial team (2004). “United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care.” Bmj 329(7479): 1377.

11. Licciardone, J., A. Brimhall, et al. (2005). “Osteopathic manipulative treatment for low back pain: A systematic review and meta-analysis of randomsied controlled trials.” BioMedCentral Musculoskeletal Disorders 6: 43.

12. Gross, A., J. Miller, et al. (2010). “Manipulation or mobilisation for neck pain: a Cochrane Review.” Man Ther 15(4): 315-33.

 

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