Download Analgesic recommendations when treating musculoskeletal sprains

Invited Clinical Commentary
Analgesic recommendations when treating musculoskeletal
sprains and strains
Rhiannon Braund, BSc (Biochemistry), BPharm, RegPharmNZ, MPS
Clinical Pharmacy Practice Lecturer, School of Pharmacy, University of Otago
J. Haxby Abbott, PhD, MScPT, FNZCP
Senior Research Fellow, Clinical Research Development
New Zealand Centre for Physiotherapy Research, University of Otago
ABSTRACT
Physiotherapists are often asked to provide treatment and advice for musculoskeletal
sprains and strains. According to some best-practice guidelines, simple analgesics
can be effective in many cases but there is often debate as to which analgesics
are most appropriate for these injuries. As physiotherapists are primary care
practitioners, a good current knowledge of these guidelines and the relevant
medications may aid in providing appropriate advice to their patients. Recently
there has been reclassification of some analgesics, allowing patients to purchase
these medications without consulting a health professional, and patients often
perceive these medications to be safe.
This paper aims to discuss pharmaceutical options for these types of injuries with a
focus on those available without a prescription; to identify appropriate indications
and contraindications of these medications; to discuss the controversy surrounding
the use of anti-inflammatory medications in the immediate post-injury period; and to
discuss patients’ access to these medications. Braund R, Abbott JH (2007): Analgesic
choice when treating musculoskeletal sprains and strains. New Zealand Journal of
Physiotherapy 35(2): 54-60.
Key Words: Sprains and Strains; Analgesics; Anti-inflammatory agents, Nonsteroidal
INTRODUCTION
Of all musculoskeletal injuries, sprains and
strains are the most common, with ankle sprains
alone reported to account for 15 percent of all
sports injuries (Almekinders 1999, Liu and
Nguyen 1999, McGriff-Lee 2003, Rubin and Sallis
1996). While such injuries are usually considered
minor, they should be taken seriously due to their
potential to cause chronic pain and functional
instability (Almekinders 1999, Osborne and Rizzo
2003). Musculoskeletal injuries of all types are
often painful, so patients often seek general sale
analgesics and other treatments.
Appropriate treatment of sprains and strains in
the first 48 hours after the injury includes rest, ice,
compression, and elevation (RICE) (Harvey 1997,
McGriff-Lee 2003). RICE should be the mainstay of
treatment in the initial period following injury and
HARM (Heat, Alcohol, Running/Resuming exercise,
and Massage) should be avoided. Oral analgesics
are recommended for the treatment of pain in
many musculoskeletal injuries (Australian Acute
Musculoskeletal Guidelines Group 2003, Accident
Compensation Corporation Guidelines 2004a&b,
Airaksinen et al 2006), but caution should be used
as they can mask symptoms that may suggest more
severe damage, and may cause uncomfortable sideeffects or serious adverse events.
Many primary healthcare professionals, including
physiotherapists, pharmacists and others, will
54
be approached by patients seeking advice and
treatment, and are often asked by their patients to
make recommendations. Currently, recommending
medication is considered outside physiotherapists’
general scope of practice (Abbott 2003). However,
this is also the case in Australia, yet there is evidence
that physiotherapists there often recommend
medications, principally simple analgesics and
non-steroidal anti-inflammatory drugs (NSAIDs)
(Grimmer et al 2002). It appears likely that the
same occurs in New Zealand (Cornford et al 2007).
It has been argued that health professionals need to
be aware of the side-effects of, and precautions in the
use of these medications, as many patients under
their care are taking them (Benson et al 1995).
The reclassification of some medications, such
as the change in status of ibuprofen becoming a
general sales medicine (April 2004) and stronger
codeine combination products available from
pharmacies (May 2005), may indicate the need
for physiotherapists to update their knowledge
of analgesic and anti-inflammatory medications
available in New Zealand,
MEDICATION AVAILABILITY
Because the symptoms of sprains and strains
include pain and inflammation, analgesics and
anti-inflammatories may be indicated. There are
currently several analgesic and anti-inflammatory
medication options available without a prescription
NZ Journal of Physiotherapy – July 2007, Vol. 35 (2)
in New Zealand. Medications are classified into
groups defining where they can be sold based
on their relative safety and therefore the need
for health professional supervision (See table 1).
Review of the classification of some medications
leads to a shift in how they can be sold. For
example, ibuprofen 200mg was reclassified from a
Pharmacy-only Medicine to a General-sale Medicine
in April 2004. This change has been met with
some controversy as this medicine can now be
purchased from any retail outlet and some question
whether it is sufficiently safe for such distribution.
However, ibuprofen in this strength is available for
general purchase in a number of other countries.
As a primary care provider, a physiotherapist may
be the only healthcare provider a patient taking
general-sale ibuprofen sees, therefore it serves
the best interests of the patient’s safety if the
physiotherapist is aware of the precautions of this
common medication, and is alert for the signs and
symptoms of side-effects.
MEDICATIONS AVAILABLE WITHOUT
A PRESCRIPTION
Paracetamol
Paracetamol is classified as a general sale
medicine due to its relative safety. Perhaps due to
its wide availability, there is often a perception that
paracetamol is a less effective analgesic (Boger and
Jones 2005), however the evidence would suggest
it is equivalently effective to NSAIDs (Gotzsche
2000). It does have both analgesic and antipyretic
effects, and differs from the majority of NSAIDs in
that it lacks significant anti-inflammatory activity
(Aronoff et al 2006).
While its exact mechanism of action is not clearly
defined (Sachs 2005) paracetamol appears to exert
some of its effects via inhibition of prostaglandin
synthesis within the central nervous system (Aronoff
et al 2006). One large clinical trial that compared
NSAIDs with paracetamol for musculoskeletal
injuries found no difference in efficacy (Woo et al
2005). Indeed there is growing support for using
paracetamol as first-line treatment as it may be just
as effective an analgesic as NSAIDs and will not
increase bleeding into the injury site or potentially
impair healing (Paoloni and Orchard 2005, Rahusen
et al 2004). Due to its efficacy, cost and side-effect
profile, paracetamol should be regarded as the
initial choice for most mild to moderate acute pain
of non-specific origin (Sachs 2005). Paracetamol is
generally considered safe in analgesic doses. The
main important potential side effect is liver toxicity
at high doses or in susceptible patients, for example
excessive alcohol use (Langford 2006).
Codeine
Codeine, an opiate analgesic, is considered a
pro-drug and requires metabolism in the body for
its analgesic effect (Sachs 2005). The individual
variability in this metabolic activity may impact on
its analgesic effect (Vree et al 2000) and so some
patients will not find it effective. An estimate in the
UK suggests 9% of patients will be poor metabolisers
(Williams et al 2001). Codeine is currently available
from pharmacies over the counter, but only in
combination products, with either paracetamol or
ibuprofen. An increased analgesic effect (synergistic
effect) of the two analgesic agents occurs when
used in combination (de Craen et al 1996, Moore
et al 1997). As with all opiates, constipation and
drowsiness can be significant side-effects. In 2005,
a combination product with 15mg of codeine was
introduced for sale in pharmacies, with a Pharmacyonly status, which is an increase from the 8mg dose
previously available.
NSAIDs
Within this group there are varying degrees of
regulations on the availability of individual drugs.
For example topical preparations of ibuprofen and
diclofenac are currently given general-sale status, as
is ibuprofen 200mg when sold in packs of less than 25
dose units. Oral diclofenac has several classifications
depending on tablet strength, including Pharmacistonly at strengths of 25mg per tablet and prescriptiononly status at higher strengths.
NSAIDs are often used in musculoskeletal
conditions due to their anti-inflammatory effects,
where they act to inhibit the production of
prostaglandins (pro-inflammatory mediators) via
their inhibition of the enzyme cyclooxygenase (COX)
(Stanley and Weaver 1998). The COX enzymes
are also important for gastrointestinal and renal
Table 1. New Zealand Medications Classification
Classification
Definition
Example
General Sale Medicines
May be sold from any retail outlet
Pharmacy or Pharmacy-only
Medicines
May only be sold from a pharmacy or
hospital
Pharmacist-only Medicines
(also called Restricted Medicines)
May only be sold by a pharmacist in a
pharmacy or hospital
Paracetamol 500mg tablets
Ibuprofen 200mg (limited pack
size)
Topical NSAIDs
Liquid paracetamol
Paracetamol and Codeine
combination products
Diclofenac 25 mg tablets
Prescription Medicines
May only be sold or supplied pursuant to
a prescription
NZ Journal of Physiotherapy – July 2007, Vol. 35 (2)
Diclofenac 75mg extended release
tablet
55
protection and this is one of the reasons that NSAIDs
have many of their side-effects, such as serious upper
gastro-intestingal (GI) complications, nephrotoxicity
and renal failure (Pham and Hirschberg 2005).
NSAIDs are associated with a 5-to-10-fold increase
in serious peptic ulcers, peptic ulcer haemorrhage,
and GI perforations (Schaffer et al 2006, García
Rodríguez & Hernández-Díaz 2002). It is important
to note that NSAIDs can also cause renal failure in
dehydrated patients: there have been numerous
reports of athletes taking NSAIDs prior to sport
becoming dehydrated, resulting in renal failure
requiring dialysis, or even death (Cronin et al 2006,
Farquhar et al 1999, Ratliff et al 2002).
COX-2 specific NSAIDs were developed after
it was shown that COX-2 was increased during
inflammation and that by targeting this enzyme
more specifically and sparing the gastro-protective
COX-1 enzyme, there might be a reduced incidence
of gastrointestinal problems such as peptic ulcers.
The COX-2 specific NSAIDs have recently been under
the spotlight with emerging evidence that there is
an increased risk of cardiovascular problems. This
has led to reinvestigation of the cardiovascular risks
for traditional NSAIDs and it appears that there is
an increased risk of cardiovascular complication
with all NSAIDs (Borer and Simon 2005, Pham and
Hirschberg 2005).
Most NSAIDs including the COX-2 inhibitors are
prescription-only medications although there are
several available without a prescription (see table
2). Interestingly, there seems to be no important
differences in efficacy between the different NSAIDs,
but there may be differences in their relative
toxicity (Henry et al 1996). In fact a major metaanalysis suggested that as ‘there are no important
differences in efficacy, choice of first line treatment
with these drugs should be based on their relative
toxicity’ (Henry et al 1996). This statement has been
supported by current clinical evidence showing that
there is no difference in efficacy between different
NSAIDs, but that there may be differences in
adverse effects (Gotzsche 2006).
Ibuprofen appears to have the best safety
profile in terms of lower risk of gastrointestinal
complications (Henry et al 1996, Sachs 2005)
but only when used at low doses. It has been
reclassified to a general-sale status in limited pack
sizes, but there is no limit to how many packs
can be purchased. While it is considered one of
the ‘safer’ NSAIDs it is important to remember
that the incidence of GI and other side-effects are
still increased, but to a lesser extent than other
NSAIDs. These medications can still be harmful in
susceptible patients, including the elderly, those
with sensitivity to NSAIDs, those with previous GI
history, and those who take high doses, and they
can also exacerbate asthma symptoms including
the potential for severe respiratory distress. It has
been shown that increasing the dose of all NSAIDs
may only slightly increase analgesic efficacy to a
maximum ceiling, but significantly increases the
side-effects (Gotzsche 2000). As there is no evidence
that NSAIDs are more effective than paracetamol
in acute musculoskeletal conditions (Gotzsche
2000), many treatment guidelines recommend
simple analgesics in most circumstances (Accident
Compensation Corporation Guidelines 2004b).
Table 2. Non-Prescription Analgesics
Joint Formulary Committee (2007)
BNF 53ed
Class
Action
Side-effects
Precautions
Specific
Medication
Usual analgesic dose
range
Non-opioid
analgesic
analgesic
antipyretic
Considered safe but
potential for liver
toxicity in high or
extended doses
Caution in
patients with
hepatic or renal
impairment
Paracetamol
0.5-1g every 4-6
hours
max of 4g per day
NSAIDs
analgesic
antipyretic
antiinflammatory
Gastrointestinal
problems
-nausea, diarrhoea,
bleeding and
ulceration
Renal impairment,
fluid retention,
increased blood
pressure, angioedema,
asthma exacerbation,
brochospasm,
hypersensitivity
reactions, hearing
disturbances and others
Not
recommended in
pregnancy.
Caution in the
elderly, those
with sensitivity
to other NSAIDs,
those with
renal, cardiac
or hepatic
impairment
and those with
coagulation
defects
Aspirin
0.3-1g every 4 hours
Diclofenac
25-50mg three times
a day or 75mg twice
daily
max of 150mg per
day
400-600mg three
times a day
max of 2.4g per day
500mg three times
a day
Constipation
Drowsiness
Not
recommended in
pregnancy
Codeine
Opioid
analgesic
56
analgesic
Ibuprofen
Mefanaminc
Acid
Naproxen
500mg initially then
250mg every 6-8
hours
max of 1.25g per
day
30-60mg every 4
hours
max of 240mg per
day
NZ Journal of Physiotherapy – July 2007, Vol. 35 (2)
Topical NSAIDs
There has been much debate about topical NSAIDs,
mainly focusing on efficacy and side-effect profile.
Topical NSAIDs have lower plasma concentrations
when compared to orally administered NSAIDs
although it is thought that the level in soft tissue
will still exert an anti-inflammatory effect (Vaile
and Davis 1998) with evidence of analgesic efficacy
above simply a placebo effect, and no difference in
efficacy compared to oral NSAID (Mason et al 2004a,
Mason et al 2004b, Moore et al 1998).
While the anticipated lower plasma concentrations
may suggest a lower systemic side-effect profile
there have been reports of adverse GI events,
as well as asthma exacerbation and acute renal
impairment with topical products (Moore et al
1998). It is also important to note that there will
be a small percentage of patients who experience
adverse cutaneous reactions.
Once again, as these are general-sale medications
many people forget about the potential for adverse
reactions in susceptible patients, although both
local and sysematic adverse events appear to be
infrequent (6% and 3% respectively) (Mason et al
2004b). There is, however, significant variation in
the amount of topical medication that people apply,
the number of times they apply it and in the size
of the area to which it is applied. All of these can
potentially impact plasma concentrations and lead
to systemic side-effects. These products should
only be applied three to four times a day depending
on strength of product used (Joint Formulary
Committee, 2007). From a practical viewpoint it is
important to note that those who apply these directly
to their patients will also be at risk of potential sideeffects, unless they protect themselves from contact
with the drug using gloves.
Current controversy surrounding use of antiinflammatory medications in the initial postinjury phase
The early and aggressive use of NSAIDs to treat
acute musculoskeletal injuries including sprains
and strains has been common in the past, in order
to halt the inflammation that leads to pain, swelling
and loss of joint mobility. However, during the first
24-48 hours following injury, the inflammatory
response is crucial for the recruitment and
activation of inflammatory mediators that act
to remove tissue damage and begin the process
of tissue repair and regeneration. This process
reaches its maximum at 48 hours. Inflammation at
the injury site acts to limit the amount of damage
(e.g. haemostasis to prevent bleeding), to protect
from further damage (e.g. swelling to immobilise
the joint) and to initiate healing (via macrophages
to remove debris and initiate regeneration) (Hertal
1997, Jarvinen et al 2005, Tidball 2005).
Inflammation is a necessary component in the
healing process and without it repair would not take
place (Harvey 1997, Stovitz and Johnson 2003).
Thus, decreasing inflammation may impair the
NZ Journal of Physiotherapy – July 2007, Vol. 35 (2)
healing process and result in a delay of tissue repair
(McGriff-Lee 2003, Reynolds et al 1995). There is
significant evidence to suggest that if these medicines
are used too early following injury, they will reduce
the inflammatory response and may actually
delay acute healing, slow muscle regeneration and
compromise long-term healing (Almekinders 1999,
Hertal 1997, Stovitz and Johnson 2003). There is
also potential for increased bleeding and swelling at
the site of injury due to NSAIDs decreasing platelet
aggregation (Mautner 2004).
RECOMMENDATIONS
RICE plays a vital role in the treatment of sprains
and strains as the rest acts to minimise further
damage, bleeding and swelling is decreased by the
ice, compression and elevation.
The World Health Organisation (WHO) developed
an “analgesic ladder” as a step-wise approach to
pain management in cancer patients. This ladder
has been applied to musculoskeletal pain and
further adapted by Boger and Jones (2005) to guide
the safe and effective use of medications for the
relief of pain in musculoskeletal conditions (Figure
1). In general, patients with musculoskeletal
pain should begin at level one, and only if relief
is not achieved should the next higher level be
engaged.
Figure 1. The “analgesic ladder” recommendations for
musculoskeletal pain, according to the modified Boger
and Jones (2005) guidelines:
Notes: Moderate and mild musculoskeletal pain should
start at Step 1. Severe pain may start at higher steps,
e.g. Step 4, under the care of a medical practitioner.
* with consideration of additional risk factors, e.g.
asthma, hypertension, renal disease, heart failure,
diabetes, stroke.
NSAIDs = non-steroidal anti-inflammatory drugs.
† including tramadol.
The mainstay of analgesic treatment of
musculoskeletal sprains and strains should
be paracetamol due to its efficacy, good safety
profile at therapeutic doses, cost-effectiveness
and availability. The addition of codeine may
provide analgesic benefit without the disruption
57
Patient Information:
Name:_______________________________________ DOB: ____ / ____ / _______
Address: ____________________________________
____________________________________________
Physiotherapist’s diagnosis: ______________________________
Reason for Referral: Consultation and advice regarding:
Anti-inflammatory
Other
analgesia
O
O
O
dermal condition
O _____________________________
Physiotherapist
Referral to
Pharmacist
Patients: Please inform the
pharmacist of ALL other
medications you are taking.
(take a list with you to the
pharmacy)
If symptoms persist,
please inform your
physiotherapist and
see your GP.
Other relevant information:
Recommendation to Pharmacist:
Please consult with this patient, and provide appropriate recommendations and related information
for the above described indications.
Physiotherapist’s signature: ______________________date: ___ / ___ / 20___
Endorsed by:
• Otago Branch
Pharmaceutical Society of New Zealand
• Otago Branch
New Zealand Society of Physiotherapists
©Otago Branch, New Zealand Society of Physiotherapists Inc.
Figure 2.A sample referral form developed and approved by the Otago Branch, New Zealand Society of Physiotherapists,
and the Otago Branch, Pharmaceutical Society of New Zealand.
of inflammation. NSAIDs have their greatest
benefit in pain that is the result of excessive or
uncontrolled inflammation such as rheumatoid
arthritis. The analgesic benefits of NSAIDs in acute
musculoskeletal conditions may be best realised
after inflammation needed to initiate healing has
passed. According to the analgesic ladder (Figure
1) paracetamol should first be tried: if ineffective,
when taken as recommended, codeine should be
added, and only after that (step 2) should NSAIDs be
considered. It has been recommended that NSAIDs
not be started until 48 hours after injury (Braund
2006). When an NSAID is used, consideration
should be given to the relative toxicity and those
with a safer toxicity profile should be chosen (i.e
diclofenac or ibuprofen). Precaution should always
be taken in those patients with a history of gastric
upset, asthma exacerbation and sensitivity to other
NSAIDs and a realisation that these may still occur
in susceptible patients even at low doses.
As providing advice to patients regarding
purchasing, taking or adjusting medications is
outside the general scope of physiotherapy practice
in New Zealand, we recommend that referral to a
pharmacist or medical practitioner is currently
best practice for physiotherapists. This avoids
unlawfully contravening the general scope of
physiotherapy practice and medico-legal liability
(Abbott 2003, S Begg, personal communication
2007). Physiotherapists may convey to patients that
58
research and best-practice guidelines recommend
medications for pain relief, and inquire whether the
patient has access to step 1 medication (Figure 1). If
the patient has, and is taking, step 1 medications,
recommend the patient follow the instructions
supplied with that medication. Indications for
referral to a pharmacist include patients with
mild to moderate pain of musculoskeletal origin
who are not taking pain medications, or who are
taking step 1 to step 3 medications. A suitable
referral form for referral to a pharmicist should
include at least two details identifying the patient
(e.g. name plus date of birth), your diagnosis,
a request that the pharmacist consult with the
patient and provide recommendations, your name
and signature, and the date. Retain a copy for your
patient records. An example is shown in Figure 2.
Indications for referral to a medical practitioner
include include patients with moderate to severe
pain, failure of step 3 medications to control
musculoskeletal pain, pain of non-musculoskeletal
origin, pain suspected to be complicated by nonmusculoskeletal factors, significant comorbidities,
age over 65, polypharmacy, or other concerns. A
suitable referral to a medical practitioner should
include at least two details identifying the patient
(e.g. name plus date of birth), a concise summary
of the patient’s history and examination findings,
your diagnosis, a description of your concerns, your
reasons for referral, your plan of care from this
NZ Journal of Physiotherapy – July 2007, Vol. 35 (2)
point (i.e. your intention to continue physiotherapy
concurrently, or transfer care over to the doctor),
your name and signature, and the date. Retain a
copy for your patient records.
Key Points
• Due to its efficacy, low cost and low side-effect
profile, paracetamol should be regarded as the
initial choice for most mild to moderate acute
pain of non-specific origin.
• There are no important differences in efficacy
within the NSAIDs and so choice of treatment
with these drugs should be based on their
relative toxicity.
• Ibuprofen appears to have the best safety
profile of the NSAIDs in terms of lower risk of
gastrointestinal complications, but only when
used at low doses.
• All medications have the potential for sideeffects in susceptible people, even at low
doses.
• Under current New Zealand law, advising
patients to purchase, consume or administer
medication is outside the general scope of
physiotherapy practice. Referral to a pharmacist
or medical practitioner is recommended.
A well-constructed written referral is highly
recommended.
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ADDRESS FOR CORRESPONDENCE
Rhiannon Braund, School of Pharmacy, University of Otago ,
PO Box 913, Dunedin. Email: [email protected].
ac.nz. Phone: 03 479 7240.
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NZ Journal of Physiotherapy – July 2007, Vol. 35 (2)