June 2010 Newsletter from Malik Slosberg, DC, MS

Dagenais S, DC, PhD, Tricco AC, PhD, Haldeman S, DC, MD, PhD. Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines. The Spine Journal 10 (2010) 514–529. This paper reviews recent guidelines including data from 2001 - 2009 published in Australia, Belgium, Europe (ALBP), Europe (CLBP), Italy, New Zealand, Norway, United Kingdom, United States (1), and United States (2).

Carnes D, Mars TS, Mullinger RF, Underwood M. Adverse events and manual therapy: A systematic review, Manual Therapy (2010), doi:10.1016 epub ahead of print.
Article #1: Dagenais S, DC, PhD, Tricco AC, PhD, Haldeman S, DC, MD, PhD. Synthesis of recommendations for the assessment and management of low back pain from recent clinical practice guidelines. The Spine Journal 10 (2010) 514–529. This paper reviews recent guidelines including data from 2001 - 2009 published in Australia, Belgium, Europe (ALBP), Europe (CLBP), Italy, New Zealand, Norway, United Kingdom, United States (1), and United States (2).

Background: The volume of literature related to LBP precludes clinicians reading all studies in their fields. Clinical practice guidelines (CPGs) locate, evaluate, & summarize the scientific evidence & are important tools in the implementation of evidence-based medicine. Adherence to recommendations from CPGs on the management of LBP is associated with improved clinical outcomes & decreased costs. However, compliance with recommendations from CPGs is consistently low in studies of MDs, DCs, PTs, & others.

Objective: Synthesize recommendations from recent clinical practice guidelines (CPGs) (based on data from 2000 – 2009) in English to provide guidance to clinicians on evidence-based assessment and management of

1) Acute LBP (<3 mo),
2) Chronic LBP (>3mo),
3) LBP with substantial neurologic involvement.

Ideally, all providers involved in managing LBP should be guided by the best available scientific evidence to minimize the use of ineffective, excessively costly, or even harmful procedures.

10 CPGs were included in the review.

6 CPGs discussed acute LBP, 6 chronic LBP, and 6 LBP with neurologic involvement.

The CPGs reviewed had high levels of methodological quality.

CPGs were not included if they were not endorsed by a national government agency or professional health provider group.

6 CPGs appeared to be endorsed by a national association of primary care physicians (PCPs), four by PTs, 4 by nonsurgical spine specialists, 3 by DCs & 2 by surgical spine specialists.

All CPGs appeared to have been sponsored or funded by their respective national governments, with the exception of those from the United States.

Recommendations for assessment of LBP:
  1. Rule out potentially serious spinal pathology,
  2. Identify specific causes of LBP and neurologic involvement
  3. Identify risk factors for delayed recovery & chronicity: Of 10 risk factors identified, 7 were psychosocial including emotional issues (anxiety and depression) & fear avoidance behavior.
  4. Measure the severity of symptoms
  5. Measure functional limitations

A synthesis of recommendations regarding the assessment of acute LBP suggests that a history, physical exam, & neurologic exam should be sufficient in the vast majority of patients.

Recommendations for management of acute LBP:

  1. Patient education,
  2. Advice to stay active
  3. Short-term use of acetaminophen, NSAIDs, or spinal manipulation (SM).
  4. No CPGs recommended bed rest, back exercises, lumbar supports, acupuncture, biofeedback, TENS, traction, or ultrasound.

Recommendations for management of chronic LBP: Recommendations are similar to ALBP but with the major addition of back exercises, as well as, behavioral therapy, short-term opioid analgesics. Brief education about LBP, advice to stay active, back schools, NSAIDs , weak opioid analgesics, back exercises , & Spinal Manipulation.

Secondary interventions:

  1. Multidisciplinary rehabilitation,
  2. Adjunctive analgesics,
  3. Behavioral therapy,
  4. Strong opioid analgesics.

No guidelines recommended: bed rest, biofeedback, lumbar supports, heat/ cold, traction, or ultrasound for chronic LBP.

Management of LBP with neurologic involvement: Recommendations are similar, but with additional consideration given to MRI, CT, or to identify appropriate candidates willing to undergo epidural steroid injections or decompression surgery if more conservative approaches are not successful.

Conclusions: Recommendations from several recent CPGs regarding the assessment and management of LBP were quite similar. Clinicians who care for patients with LBP should endeavor to adopt these recommendations to improve patient care.

Commentary: Here is a major review of all recent guidelines in English from the United States & the United Kingdom. There is a great deal of consistency in the various guidelines concerning both assessment and management. These CPGS were from Australia, Belgium, Europe (ALBP), Europe (CLBP), Italy, New Zealand, Norway, United Kingdom, & 2 from the United States. 6 of the CPGs had DCs as participating panelists.

Of 16 total guidelines recommendations on ALBP, CLBP, & LBP with neurologic involvement all but 2 (14 of 16) recommended spinal manipulation.

Of 6 total guidelines on management of ALBP none recommended exercise, but 5 of 6 recommended SM.

All 6 guidelines on management of CLBP recommended exercise.

Only one of 16 guidelines recommended traction & that is auto-traction for neurologic involvement from the USA.

Bedrest is only recommended in 1 of 16 guidelines (from Italy for LBP with neurologic involvement).


Article #2: Carnes D, Mars TS, Mullinger RF, Underwood M. Adverse events and manual therapy: A systematic review, Manual Therapy (2010), doi:10.1016 epub ahead of print.

Objective: To explore the incidence and risk of adverse events with manual therapies.

Method: The main health electronic databases, plus those specific to allied medicine & manual therapy, were searched. Inclusion criteria: manual therapies only; administered by regulated therapists; a clearly described intervention; adverse events reported. A meta-analysis was performed Results: 8 prospective cohort studies & 31 manual therapy RCTs were reviewed.

Adverse Events Defined:
Major
: medium to long term; moderate or severe intensity
Moderate: medium to long term; moderate intensity
Minor: short term and mild intensity

8 prospective cohort studies: Represented at least 36,949 manual therapy treatments that included manipulation in 22,898 patients.
Major adverse events: Of the 8 studies, one reported 14 cases of ‘unbearably severe side effects’ in 4712 treatments (0.13%). One reported an upper risk rate for ‘serious adverse events’ of approximately 0.01% (3/28,109 consultations). Combining all the data from the cohort studies it is estimated, an upper incidence risk rate of major adverse events of 0.007% (0/42,451) after treatment or 0.01% (0/22,833) per patient.
Minor and moderate adverse events: The estimate of incidence of minor or moderate adverse events in patients or after treatment consultations was ~41%. The majority of minor or moderate adverse events reported by patients occurred within 24 h of treatment and most resolved within 48 h. One study reported that 72% of adverse events occurred after the first treatment.

Randomized controlled trials: 36 papers detailing adverse event data from 31 RCTs, representing 5060 participants. Major adverse events: There were no reports of any major adverse events in any trial.

The 31 RCTs included 2281 participants who received manual therapy and 2779 who received other therapies. 15 trials reported that no adverse events occurred regardless of the intervention administered.

We estimated an upper incidence rate of major adverse events of ~0.13% after manual therapy treatment. Mild and moderate adverse events: The estimate of incidence of minor or moderate adverse events in the manual therapy section of the RCTs was 22%. Meta-analyses of data comparing manual therapy with other interventions: Manual therapy interventions, predominately manipulation, produced more adverse events than general practitioner care with a relative risk (RR 1.91), about the same number as exercise (RR 1.04), and fewer than drug therapy (RR 0.05 versus NSAIDs and amitriptyline). There was a nonsignificant trend for manual therapy to produce more adverse events than sham, passive or control interventions.

Overall, the incidence estimate for minor or moderate transient adverse events after manual therapy was ~41% in the cohort studies and 22% in the RCTs; for major adverse events ~0.13%. The pooled relative risk (RR) for experiencing adverse events with exercise, or with sham/passive/control interventions compared to manual therapy was similar, but risk for major adverse events for drug therapies was greater (RR 0.05) & less with usual care (RR 1.91). No deaths, cerebrovascular accidents or stroke were reported in any of the prospective cohort studies or RCTs.

Conclusions: The risk of major adverse events with manual therapy is low, but around 41% of manual therapy patients may experience minor to moderate adverse events after treatment. The risk of adverse events appears greater with drug therapy but less with usual care.

Commentary: This is an impressive review of the literature which looks at severity and frequency of adverse events related to manipulation. The review includes of approximately 28,000 patients who received manipulation and more than 50,000 treatments is just the kind of database we need to document how exceptionally rare serious adverse events are. The overall estimate of a major adverse event is ≈0.13% which the authors is explain is similar to risk with exercise or sham/passive/control interventions. In addition, risk of major adverse events was much greater with the medications (NSAIDs and amitriptyline) to which manipulation has been compared. It is data like this which, when shared with patients and other health professionals, can diminish the hoopla and hype sometimes seen in the media and vociferously screamed by opponents of spinal manipulation and chiropractic.