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7 - Overview of the development of clinical guidelines for acute soft tissue injuries during the first 72 hours

The development progressed through a number of phases:

7.1 - The literature search

7.1.1 - Search strategy

The aim of the search was to identify those papers in the published literature that provided evidence on the application of the individual elements of the PRICE regimen. The major focus was to find studies in which the specific mode of application of the elements of PRICE had been investigated.

The original search was carried out through the CSP Information Resource Centre, and searched the following indices and databases from 1982-February 1996.

• Physiotherapy Index
• Rehabilitation Index
• Complementary Medicine Index
• CSP Research Database
• CSP Documents Database
• MEDLINE
• CINAHL

An additional search was carried out on the EMBASE database (1988-February 1996) The following keywords were entered into the search:

• Soft tissue injury
• Athletic injury
• Sports injury
• Ligament injury
• Muscle injury
• Tendon injury
• Acute injury
• Musculoskeletal injury

These were combined with:

From the search, 109 papers were read, of which 57 were critically reviewed.

A second search was undertaken in June 1998, using the following databases, and the same keywords and combinations.

• BIDS / EMBASE
• MEDLINE
• The Cochrane library

This search produced 11 additional papers, of which seven were ultimately critically reviewed.

7.2 - Reviewing the literature

Where possible, the papers were divided into topic areas according to the individual elements of PRICE, and each group of papers was reviewed by two members of the development group.Those studies which reported research findings were evaluated according to the guidelines set out by Domholdt and Malone (1985). Where papers covered more than one element of PRICE, they were reviewed by more than one pair of reviewers, each pair concentrating on specific elements. The conclusions drawn by each pair of reviewers was then presented to the development group as a whole, and discussed fully before the guideline statements were created from the evidence. Where evidence was unclear, or lacking, the group created proposed guideline statements, which then were put forward for discussion by the consensus panel.

7.3 - Assessing the evidence

On initial reading of the literature, it was immediately apparent that unlike research into the effectiveness of a specific intervention for a specific problem, the literature pertaining to the mode of application of the individual elements of the PRICE regimen was not in the form of the traditional “gold standard” of the randomised controlled trial. Consequently, it has not been possible to grade the evidence on the categories based on either the Canadian Task Force Classifications (1979), or those proposed by the Agency for Health Care Policy and Research (Grisham et al, 1994), both of which are based around the randomised controlled trial.

7.3.1 - Categorising the evidence

Much of the literature reviewed has tended to make assumptions about the mode of application of the elements of PRICE in terms of duration and frequency, without providing evidence for the specified mode. For example, although many studies have used ice as an intervention, the duration of application has varied among studies, with authors rarely justifying their selection. In view of the nature of the literature, it was decided to appraise the evidence according to categories suggested by Bogduk and Mercer (1995) who suggest that any form of treatment, be it in medicine at large, in musculoskeletal medicine or in musculoskeletal physiotherapy, can be appraised against three distinct but complementary axes. These are biological bases, convention and empirical proof.

Biological bases

Provide the rationale for treatment which is based on the identification of the mechanism of a symptom and the application of a therapy which is known to reverse that mechanism. Thus, under this axis, the subject under consideration is not whether the therapy ‘works’ but whether or not the therapy has a reliably-proven biological basis which allows it to be applied in a generic manner. This axis can be applied to animal studies, and to laboratory based studies, which can demonstrate efficacy of a specific intervention on either a biochemical or physiological bases, or on an animal model, but cannot directly infer the same in a human subject.

Convention

Is a ’socially powerful but intellectually weak’ dimension (Bogduk and Mercer, 1995). The power of this dimension lies in the perceived established and authoritative views of senior members of a profession who ‘have always used this’ and whose practice is unlikely to be disputed by younger and less experienced members. Convention is also a resort when there is no other legitimate basis for a therapy. Although not necessarily based in a strong proven basis, consensus might be regarded as providing a stronger argument for application of a form of treatment than convention. Grisham et al (1994) define strong consensus as having agreement among 90 per cent or more of panel members and expert reviewers, and consensus as having agreement amongst 75-89 per cent of panel members and expert reviewers.

Empirical proof

Relates to valid clinical evidence of the efficacy of a treatment. This axis specifically addresses the concept that, irrespective of whether the mechanism of a therapy is known and irrespective of how ‘popular’ a treatment is amongst therapists, a therapy becomes legitimate only when its clinical efficacy is proven. Conversely, even if a particular therapy is popular amongst therapists, it can be outrightly condemmed if it fails to be vindicated in a properly controlled trial (Bogduk and Mercer, 1995). This category was applied to clinical studies, both experimental and observational.

7.3.2 - Gaining consensus

The convention axis proposed by Bogduk and Mercer (1995) was modified slightly to encompass more of a consensus view which was be derived from an expert panel comprising the group involved in the development of these guidelines, the Executive Committee of the ACPSM and regional representatives of ACPSM, who represent each of the Sports Council regions. All members are chartered physiotherapists, with considerable and varied experience in sports medicine, and the management of soft tissue injuries. The executive committee consists of eight sitting members plus vice-presidents, and meets twice each year. The complete ACPSM committee has, in addition to the Executive Committee, potentially an additional 14 members, representing the regions, and also meets twice each year. As the guidelines were developed, they were presented at all meetings of the ACPSM committees, where those statements proposed by the development group, which had little or no supporting evidence, were discussed until agreement on the guideline statement was reached. Evidence of current practice from a questionnaire was also considered in reaching consensus (7.4).

The composition of the panel is shown in Appendix D.

7.3.3 - The quality of the evidence

While recognising the limitations of the nature of the literature, with a limited number of randomised controlled trials (RCTS) which specifically investigate the mode of application of the elements of PRICE, a modification of the Canadian Task Force Classifications (1979) has been developed, in an attempt to acknowledge those studies which have a sound scientific basis, whether they are animal, laboratory or clinically based.

7.4 - Current practice

Current practice with regard to the application of PRICE during the first 72 hours following injury has been determined through the analysis of a questionnaire distributed to 500 ACPSM members. A brief summary of the results of the questionnaire are shown in Appendix E and summaries of the findings of the questionnaire with respect to each of the elements of PRICE are provided at the end of each guideline. Thus the recommendations from the guidelines can be compared with current practice. In the long term, evaluation of implementation of the guidelines will be possible by carrying out a second survey to determine if they have influenced practice.

7.5 - Guideline statements

For each statement on each element of the regimen involving Protection, Rest, Ice, Compression and Elevation an indication will be given regarding the nature and quality of evidence supporting the application of that element; in some cases some of the elements will be combined to reflect the nature of the supporting evidence.

7.6 - Peer review / pilot

On completion, the guidelines document was sent to six professionals involved in sports medicine, who were asked for comments on clarity, content, usefulness and comprehensiveness. The names and designations of these “reviewers” are noted in the acknowledgements at the beginning of this document. All comments from these reviewers were taken into consideration, and amendments made to the document where deemed appropriate by the development group. Most of these involved minor points of clarification, particularly with respect to a clear statement as to for whom the guidelines were written. Specific comments from these reviewers can be seen in Appendix F, together with the responses from the guideline development panel.

The guidelines were also made available to members of the committee of ACPSM (see 7.3.2) at regular stages of development, and comments sought and implemented.

7.7 - Factors to be considered in applying the guideline

7.7.1 - Initial examination

Take account of:

• History - current medication, pre-existing problems, allergies, previous treatment
• Mechanism of injury
• Pain
• Swelling
• Function - range of motion, muscle performance, quality of movement
• Deformity
• Temperature
• Colour

Indications for immediate referral:

• Immediate gross swelling - indicates extensive bleeding from injured tissues
• Deformity - may indicate complete rupture of muscle/ligament or fracture of bone
• Severe loss of function - may indicate any of the above, plus nerve lesion
• Head injury
• Spinal injury
• Loss of pulse - indicates circulatory involvement
• Blanching or rapid gross discoloration - indicates circulatory impairment or gross bleeding
• Severe abdominal pain
• Severe shortness of breath

7.7.2 - Early (immediate) management

Protection

Required to protect the injured tissues from undue stress which may disrupt the healing process and delay rather than promote healing. A further obvious function of protection is to remove the athlete from the location of injury.

Protection may be applied by:

• Plaster cast
• Taping
• Bandaging
• Splints
• Slings
• Crutches (protection from weight-bearing)
• Bed rest

Rest

Required to reduce the metabolic demands of the injured area and thus avoid increased blood flow. Also needed to avoid placing undue stress on the injured tissues that may disrupt the fragile fibrin bond which is the first element of the process of repair. Rest may be applied selectively, to allow some general activity, but the patient must avoid any activity involving the injured area which may compromise the healing process.

Rest may be achieved by:

• Advice - the patient is advised not to participate in any activity which might place undue stress on the injured tissues
• Avoidance of movements which replicate the mechanism of the injury and / or which cause / increase pain
• The use of crutches, slings etc., which provide a means by which the injured area can be rested from participation in normal functional activity

Total rest is rarely required - this is difficult to achieve and advice to avoid all activity rarely meets with good compliance, particularly from athletes!

Although the injured structures should be rested during the early stages of the healing process, adjacent structures should be exercised. However, general activity should be reduced during this period to reduce metabolic rate and tissue demand for oxygen, decrease heart rate and blood pressure and consequently reduce blood flow. The concept of rest to promote the early part of the healing process and protect the newly formed repair tissue, together with controlled exercise / movement of the injured part to provide the stresses necessary for the correct alignment of the healing tissues, must be carefully balanced.

Ice

Ice is the most common means by which cryotherapy (or cold therapy) is applied. At this point, therefore, ice will be used to represent the application of cryotherapy in general, with the different means by which this may be applied being considered in more detail later. Ice is used in an attempt to limit the damage caused by the injury, by reducing the temperature of the tissues at the site of injury and consequently reducing metabolic demand, inducing vasoconstriction and limiting the bleeding. Ice may also reduce pain by increasing threshold levels in the free nerve endings and at synapses, and by increasing nerve conduction latency to promote analgesia.

Considerations in the application of ice:

• Duration of application (ranges from five minutes to 40 minutes) - consider the evidence for the most effective duration of application
• Frequency of application - consider duration of effects
• The area to be covered
• Nature of underlying structures
• The most effective means of application

Compression

Compression is applied to limit the amount of oedema caused by the exudation of fluid from the damaged capillaries into the tissue. Controlling the amount of inflammatory exudate reduces the amount of fibrin (and ultimately the production of scar tissue) and helps to control the osmotic pressure of the tissue fluid in the injured area.

Considerations in the application of compression:

• The most effective methods of application
• Duration of application
• Area of application
• Mode of application - intermittent or continuous, with or without ice
• How long do you continue to apply compression?

Elevation

Elevation of the injured part lowers the pressure in local blood vessels and helps to limit the bleeding. It will also increase drainage of the inflammatory exudate through the lymph vessels, thus reducing/ limiting oedema and its resultant complications.

Considerations in the application of elevation:

• Mode of elevation
• Duration of elevation
• Frequency of elevation