DOCTYPE = ARTICLE

Team Physicians Corner

The Use of Ice in the Treatment of Acute Soft-Tissue Injury

A Systematic Review of Randomized Controlled Trials
Chris Bleakley,* BSc (Hons), MCSP, Suzanne McDonough, PhD, MCSP, and Domhnall MacAuley, MD, FISM From the Rehabilitation Science Research Group, University of Ulster at Jordanstown, Antrim, Ireland, and the Department of Epidemiology, Queens University, Belfast, Ireland.

Background: There are wide variations in the clinical use of cryotherapy, and guidelines continue to be made on an empirical basis. Study Design: Systematic review assessing the evidence base for cryotherapy in the treatment of acute soft-tissue injuries. Methods: A computerized literature search, citation tracking, and hand searching were carried out up to April 2002. Eligible studies were randomized-controlled trials describing human subjects recovering from acute soft-tissue injuries and employing a cryotherapy treatment in isolation or in combination with other therapies. Two reviewers independently assessed the validity of included trials using the Physiotherapy Evidence Database (PEDro) scale. Results: Twenty-two trials met the inclusion criteria. There was a mean PEDro score of 3.4 out of of 10. There was marginal evidence that ice plus exercise is most effective, after ankle sprain and postsurgery. There was little evidence to suggest that the addition of ice to compression had any significant effect, but this was restricted to treatment of hospital inpatients. Few studies assessed the effectiveness of ice on closed soft-tissue injury, and there was no evidence of an optimal mode or duration of treatment. Conclusion: Many more high-quality trials are needed to provide evidence-based guidelines in the treatment of acute soft-tissue injuries. Keywords: ice; cryotherapy; soft-tissue injury; acute

Cryotherapy is perhaps the simplest and oldest therapeutic modality in the treatment of acute soft-tissue injuries. It is proposed that by decreasing tissue temperature, ice can diminish pain, metabolism, and muscle spasm, minimizing the inflammatory process and thereby aiding recovery after soft-tissue trauma.32 The majority of research studies and reviews to date have used healthy human subjects to investigate these proposed physiological effects. Although there is evidence that cryotherapy can reduce deep-tissue temperature in both animal2 and human subjects,16,46,65 the degree of cooling seems to depend on the method and duration of application, the initial temperature of the ice, and even the depth of subcutaneous fat.40
* Address correspondence and reprint requests to Chris Bleakley, University of Ulster, Jordanstown, Rehabilitation Science Research Group, Shore Road, Newtownabbey, Co. Antrim, BT37OQB Ireland. The American Journal of Sports Medicine, Vol. 32, No. 1 DOI: 10.1177/0363546503260757 2004 American Orthopaedic Society for Sports Medicine

Few literature reviews have considered the clinical evidence base. Kerr30 attempted to produce clear, evidencebased guidelines for an optimal cryotherapy protocol; however, the majority of recommendations for practice were finalized by expert consensus. A recent systematic review of the original literature provided preliminary recommendations for an optimal treatment protocol40; however, few clinical studies were discussed, and conclusions were derived from studies using only animal or healthy human subjects. To date, no review has measured the quality of the study methodology or considered the clinical appropriateness of applied treatments within cryotherapy research. The current recommendations in standard textbooks on the clinical use of ice also have many shortcomings,39 and most physicians rely on empirical evidence. The selection of parameters in a clinical environment continues to be made pragmatically, and recommendations in review articles range from 10 to 20 minutes 2 to 4 times per day,29 up to 20 to 30 minutes,60 or 30 to 45 minutes31,32 every 2 hours. The most recent surveys of clinical practice have

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identified variations on the optimal mode, duration, and frequency of ice application,28,30 yet such factors dictate the degree of cooling40 and the potential effectiveness of treatment. In addition, ice is commonly combined with compression and elevation, making it difficult to determine the value of cryotherapy alone.45,55,61 Although cryotherapy has been promoted in the immediate18,32,41,43,45,52,60 and rehabilitative31,32,55 care of soft-tissue injury, the basis for its application at each stage is quite different. Immediately postinjury, ice is principally used to reduce metabolism, thereby minimizing secondary hypoxic injury and the degree of tissue damage.31,32 In contrast, when applied for rehabilitative purposes, it is used primarily to relieve pain, which facilitates earlier and more aggressive exercise.31,32 Currently, many clinicians do not fully understand the pathophysiological rationale at each stage and may not be using it to its full advantage.31 Cryotherapy is an accessible and popular treatment modality for the physician and layman, and its use must be supported by high-quality research evidence. Therefore, the aim of this study is to explore the clinical evidence base for cryotherapy, and the specific objectives are the following: 1. to identify randomized-controlled studies assessing the effect of cryotherapy on acutely injured human subjects; 2. to assess for the presence of confounding concomitant therapies; 3. to study the modes, duration, and frequency of cryotherapy treatments employed and assess for evidence of an optimal treatment protocol; 4. to identify when cryotherapy was initiated in relation to the injury and study the goals of treatment in each study, that is, for immediate care or rehabilitation; and 5. to make conclusions on the strength of the evidence supporting the use of cryotherapy in treating acute soft-tissue injuries and make recommendations for future research.

TABLE 1 Hand Search of Key Journals

Journal British Journal of Sports Medicine International Journal of Sports Medicine Australian Journal of Sports Medicine Sports Medicine Medicine and Science in Sports and Exercise Journal of Sports Medicine and Physical Fitness Journal of Orthopaedics and Sports Physical Therapy Archives of Physical Medicine and Rehabilitation Physiotherapy Physical Therapy Year range of search 1988 to December 2001 1995 to December 2001 1984 to December 2001 1987 to December 2001 1978 to December 2001 1988 to December 2001 1986 to December 2001 1989 to December 2001 1988 to December 2001 1986 to December 2001

METHODS Search Strategy and Selection of Studies

Relevant studies were identified using a computer-based literature search on a total of eight databases: Medline on Ovid (1966 to April 2002), Proquest (1986 to April 2002), ISI Web of Science (1981 to April 2002), Cumulative Index to Nursing and Allied Health (CINAHL) on Ovid (1982 to April 2002), the Allied and Complementary Medicine Database (AMED) on Ovid (1985 to April 2002), the Cochrane Database of Systematic Reviews, the Cochrane Database of Abstracts of Reviews of Effectiveness, and the Cochrane Controlled Trials Register (Central) (last search April 2002). For the Medline, CINAHL, and AMED databases, the first two levels of the Medline optimal search strategy8 were combined with the following medical sub-

ject headings and free-text topic words: surgery, orthopaedics, sports injury, soft-tissue injury, sprains and strains, contusion, athletic injury, acute, compression, cryotherapy, ice, RICE, and cold. The remaining five databases had less sophisticated interfaces; therefore, a different search strategy was performed. To maximize the yield of relevant articles, this strategy sacrificed precision in favor of sensitivity.9 A series of 68 small searches were performed on each database by combining 13 keywords (surgery, orthopaedic, sport, injury, soft-tissue, sprain, strain, contusion, compression, cryotherapy, ice, RICE, and acute) using Boolean logic (AND). In addition, a smaller search was undertaken on the Physiotherapy Evidence Database (PEDro) (1966 to April 2002) using five keywords (ice, cryotherapy, cold, injury, and surgery). This was supplemented with citation tracking of relevant primary and review articles (n = 63) and all incoming full-text papers (n = 55). A convenience sample of 10 key journals was also hand searched to identify articles that may have been missed in database and reference list searches (Table 1). To be included within the review, studies had to fulfill the following conditions: the study should be a randomized-controlled trial of human subjects; it should be published in English as a full paper; subjects should be recovering from acute soft-tissue injuries or orthopaedic surgical interventions; therapy should be inpatient, outpatient, or home-based cryotherapy treatment, used either in isolation or in combination with placebo or other therapies; comparisons should have been made to no treatment, placebo, a different mode or protocol of cryotherapy, or other physiotherapeutic interventions; and outcome measures must have included at least one of the following: function (subjective or objective), pain, swelling, or range of movement (ROM). In the first stage of selection, the titles and abstracts of all studies were assessed for the above eligibility criteria. If it was absolutely clear from information provided in the

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TABLE 2 Physiotherapy Evidence Database (PEDro) Scoring Scale

1. 2. 3. 4. 5. 6. 7. 8. 9. Eligibility criteria were specified Subjects were randomly allocated in groups Allocation was concealed The groups were similar at baseline regarding the most important prognostic indicators There was blinding of all subjects There was blinding of all therapists who administered the therapy There was blinding of all assessors who measured at least one key outcome Measures of at least one key outcome were obtained from more than 85% of the subjects initially allocated to groups All subjects from whom outcome measures were available received the treatment or control condition as allocated or, when this was not the case, data for at least one key outcome were analyzed by intention to treat The results of between-group statistical comparisons are reported for at least one key outcome measure The study provides both point measures and measures of variability for at least one key outcome Yes/No 1 1 1 1 1 1 1

10. 11.

1 1 1 10

Total points

title and/or abstract that the study was not relevant, it was excluded. If it was unclear from the available abstract and/or title, the full-text article was retrieved. Full-text articles were also retrieved for studies with a relevant title but no available online abstract. There was no blinding to study author, place of publication, or results. The primary researcher assessed the content of all full-text articles, making the final inclusion/exclusion decisions.

was initiated in relation to the time of the injury and the specific purpose for its application, that is, for immediate care or for rehabilitative purposes in conjunction with therapeutic exercise. Means and standard deviations for the four key outcome measures were extracted, and where possible, individual study-effect estimates were calculated. This took the form of standardized mean differences (SMD)24 for continuous data or risk ratios (RR) for dichotomous data, each with 95% confidence intervals (95% CI).25

Assessment of Methodological Quality and Data Extraction

All eligible articles were rated for methodological quality, using the PEDro scale. Derived from the Delphi list,62 this scale consists of an 11-item checklist, configured by expert consensus to rate the quality of randomized-controlled trials50 (Table 2). It is routinely used to rate the quality of randomized-controlled trials on the PEDro (ptwww.cchs.usyd.edu.au/pedro). Reviewed studies were awarded one point for each criterion that was clearly satisfied. As criterion 1 is a measure of the studys external validity, it was not included in the final PEDro score, giving each study a possible maximum score of 10 on the PEDro scale. To increase the accuracy of the PEDro ratings, two independent reviewers assessed the quality of eligible studies. Disagreement or ambiguous issues, which arose between the first two raters, were resolved by either consensus discussion or consultation with a third party.

RESULTS
From the initial examination of citations yielded from the literature search, 55 studies were included. After review of the complete texts, 33 studies were excluded, leaving 22 eligible randomized controlled trials to be included in the review. Figure 1 shows the Quality of Reporting of MetaAnalysis (QUORUM) statement flow diagram,49 summarizing the process of study selection and the number of studies excluded at each stage, with reasons.

Study Quality
The 10 criteria and final scores assigned to each study are presented in Table 3. Overall, the source of subjects and their eligibility criteria were well reported. Randomization was stringently performed, and only four studies1,15,63,64 employed unsatisfactory methods. In contrast, a very small number of studies provided adequate information on subjects baseline data,11,15,20,35,38 and only three used concealed allocation during subject recruitment.34,36,38 In general, blinded application of treatment intervention was also poor; none of the studies blinded the therapists administering therapy, and just one group of subjects57 was blinded. In addition, in all but four trials6,19,36,59 there was insufficient blinding of outcome assessment. Intention to treat analysis was adequately performed in just one study,26 and eight10,11,27,34,35,47,51,57,64 supplied adequate

Data Extraction and Analysis

The primary reviewer extracted all study characteristics and data into summary tables. The type of acute soft-tissue injury and interventions applied was noted. For each intervention, the mode, duration, frequency of cryotherapy, surface temperature of the cooling device, subjects tissue temperature, and concomitant therapies were recorded. Attempts were also made to determine when cryotherapy

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No Hits.

Medline

CINAHL

Proquest

WOS

AMED

Cochrane

TABLE 3 Final Physiotherapy Evidence Database (PEDro) Scores for Included Trials
Author Cote et al.11 Michlovitz et al.47 Lessard et al.36 Hochberg26 Healy et al.23 Schroder and Passler58 Konrath et al.34 Whitelaw et al.63 Laba35 Sloan et al.59 Edwards et al.19 Cohn et al.10 Wilkerson and Horn-Kingery64 Ivey et al.27 Scarcella and Cohn57 Dervin et al.15 Barber et al.1 Ohkoshi et al.51 Bert et al.4 Levy and Marmar38 Gibbons et al.20 Brandsson et al.6
a

3321

390

5039

4640

130

1819 (CDSR) 183 (DARE) 3644 (CCTR)

Criterion no. satisfieda 2, 4, 8, 10, 11 2, 8, 10, 11 2, 3, 7, 10, 11 2, 9, 10, 11 2, 10 2, 10, 11 2, 3, 8, 10 10 2, 4, 8 2, 7, 10 2, 7, 10, 11 2, 8, 10, 11 8, 10, 11 2, 8, 10, 11 2, 5, 8, 10, 11 4, 10, 11 10 2, 8, 10, 11 2 2, 3, 4, 10, 11 2, 4, 10 2, 7, 10, 11

Total score 5 4 5 4 2 3 4 1 3 3 4 4 3 4 5 3 1 4 1 5 3 4

Potentially relevant studies retrieved for detailed evaluation of full text (n=55)

Studies excluded after evaluation of full text (n =33) Animal subjects (n=3) Healthy human subjects (n=2) Experimentally induced injury (n=2) Non-acute injury (n=2) Controlled trial / Observational trial / Case study (n=14) Inadequate outcome measures (n=1) Variable subject inclusion criteria (n=3) No cryotherapy treatment applied (n= 4) Ice treatment standardized across groups (n=2)

Studies eligib le for inclusion in systematic review (n=22)

Figure 1. The Quality of Reporting of Meta-Analysis (QUORUM) statement flow diagram. CINAHL = Cumulative Index to Nursing and Allied Health; WOS = Web of Science; AMED = Allied and Complementary Medicine Database; CDSR = Cochrane Database of Systematic Reviews; DARE = Cochrane Database of Abstracts of Reviews of Effectiveness; CCTR = Cochrane Controlled Trials Register. information on patient dropout. Between-group statistical comparisons were well reported, however, and the majority also included measures of group variability. Final values were low, ranging from 1 to 5, with a mean PEDro score of 3.4 of 10.

Criterion 1 is not included in final PEDro score.

Study Characteristics
The study population, intervention, outcomes, follow-up, and reported results of the assessed trials were extracted and tabulated. Twenty-two trials were included, using a total of 1469 subjects. The sample size ranged from 21 to 143, and the mean number of subjects used was 66.7; however, only one study26 undertook a power analysis prior to commencement of the trial. Patients had a wide variety of acute injuries. There were no studies using subjects with muscle contusions or strains, and only five used subjects with acute ligament sprains.11,35,47,59,64 The remaining 17 studies used patients recovering from a range of operative procedures: ACL reconstruction,1,6,10,15,19,34,51,58 total knee arthroplasty (TKA),20,23,27,38,57a total hip arthroplasty,57b knee arthroscopy,36,63 lateral retinacular release,4 and carpal tunnel release (CTR).26

Table 4 summarizes the mode, duration, and frequency of cryotherapy; the total cryotherapy treatment time (overall dosage); the time cryotherapy was initiated in relation to the injury; and the number of days of treatment for each included study. In total, five different modes were used: crushed or chipped ice, Cryocuff or cold compressive devices, commercial ice machines, commercial/gel ice packs, and ice submersion. Five studies10,47,58,63,64 simply stated that an ice bag or pack was applied, and 8 studies4,10,23,26,34,58,63,64 used more than one mode of cooling during the trial. Similarly, the duration and frequency of cryotherapy treatments were not consistent across studies. A total of 13 studies applied cryotherapy continuously after injury, 7 studies employed an intermittent protocol, and 5 failed to specify the protocol. With such an array of icing protocols, the total treatment time subjects received was extremely diverse. For one group of subjects, the entire course of cryotherapy treatment consisted of just 20 minutes cooling35 compared to others whose treatment time ranged from 21657 to 336 hours.58 The temperature of the cooling device and the subjects tissue temperature reduction were poorly reported. Although a number of studies4,10,26,27,34,51,57 using commercial machines stated the temperature of water flowing through the machine, they failed to provide adequate information on the actual surface temperature of the cooling device. Skin temperature reduction during treatment was reported in just one study,34 with another measuring intra-articular knee temperature.51 Three studies4,20,26

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TABLE 4 Cryotherapy Protocol Employed Within Included Studiesa

Total cryotherapy time (overall dosage) (hours) 1 1.5 9.3 36 18 336 0.3 0.5 36 96 1.5 64 64 216 216 5560 64 48 average 48 27 64 78 24

Study

Mode Water bath + exs Ice pack Gel pack + exs Commerical m Crushed ice; commercial p Cryocuff Crushed ice Cryocuff Ice bags Commercial m Crushed ice Cryocuff Crushed ice Commercial Cryocuff Commercial Ice bag Ice pack Commercial Commercial Commercial Commercial Cryocuff Commercial

Rx duration (hours) 0.3 0.5 0.3 12 0.3 Continuous 0.3 0.5 Continuous Continuous 0.5 Continuous Continuous Continuous Continuous Continuous Continuous

No. Rx/day 1 1 4 1 18 Continuous 3 1 1 Continuous Continuous 1 1 Continuous Continuous Continuous Continuous Continuous Continuous 3 3 7 3

No. days treated

Time/place of cryotherapy initiation Third day postinjury 128 hours postinjury At home after discharge Immediately after surgery Immediately after surgery Unclear Unclear Prior to tourniquet release Unclear Unclear Unclear Unclear Unclear Day 02 since injury Within 24 hours of injury In operating theatre In operating theatre In recovery room Acute stagesc Acute stagesc In recovery room In operating theatre In operating theatre Unclear After application of postoperative dressing After surgical wound was covered Immediately postsurgery in recovery room After skin closure and dressing were applied Immediately after the surgical procedure After surgical wounds were closed

Cote et al.11 Michlovitz et al.47 Lessard et al.36 Hochberg26a Hochberg26b Healy et al.23a Healy23b Schroder and Passler58a Schroder et al.58b Konrath et al.34a Konrath34b Whitelaw et al.63a Whitelaw63b Laba35 Sloan et al.59 Edwards et al.19 Cohn et al.10a Cohn10b Wilkerson and Horn-Kingery64 Wilkerson64 Ivey et al.27 Scarcella and Cohn57a Scarcella57b Dervin et al.15 Barber et al.1

p m

p m m m m

3 14 35 days post D/C 1 1 1.5 4 1 Acute phasec Acute phasec 3 9 9 2.5 3 (POD 1-3) 3 (POD 46) 2 12 3 13 (at least) 1

Ohkoshi et al.51 Bert et al.4 Levy and Marmar38 Gibbons et al.20 Brandsson et al.6

Commercial m Continuous Commercial m/p Continuous Cryocuff Cryocuff Cryocuff Continuous 6 (at least) Continuous

Continuous Continuous Continuous 1 Continuous

a Rx duration = treatment duration; No. Rx/day = number of treatments per day; + exs = Exercises incorporated with cooling; commercial m = Commercial icing machine; Commercial p = Commercially produced ice pack; = information not reported; D/C = discharge; POD = Postoperative day. b The superscripts a and b after the study reference number depict that a single study applied more than one cryotherapy protocol c Acute stage of injury not specified.

stated that cryotherapy was initiated immediately after surgery; however, they failed to provide a quantifiable time period. Likewise, others stated that cooling began prior to tourniquet release,58 in the recovery room,27 in the operating theatre,10,19,57 or after wound closure and dress1,6,7,38,51 Most studies using subjects post ing application. ankle sprain initiated cryotherapy between day 1 and 3 postinjury.11,35,47,59 One study64 initiated cryotherapy in the

acute phases of injury but again failed to state a definite time period. Few studies reported the specific goals of cryotherapy, and it is not clear whether cooling was employed for immediate care or for rehabilitative purposes. Only two studies11,36 stated that cryotherapy was applied in conjunction with exercise, for rehabilitative purposes. It seems that the majority of studies,1,10,20,26,27,34,38,57,58 despite continuing cryotherapy for

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days and even weeks after the immediate stages of trauma, chose not to incorporate functional movements or exercise.

Outcome Measures
Pain (visual analogue scale and/or analgesic consumption) was the most common outcome measure, but only two studies provided adequate data for function.57,64 Few dichotomous measures were used, and the majority of studies recorded continuous measures over short time periods (for example, 1-week postinjury). The longest reported follow-ups were measures of pain, swelling, and ROM recorded at 4 weeks postinjury58; however, insufficient data were available for effect size calculation. The longest follow-up data from which an effect size could be calculated was a measurement of knee ROM recorded 2 weeks postsurgery.38 In total, nine studies6,19,20,23,34,57-59,63 failed to provide sufficient data for any of the key outcome measures, and it was not possible to calculate individual study effect estimates (either SMD or RR).

Effectiveness of Treatment
A total of 12 treatment comparisons were made. Table 5 subgroups the studies according to treatment comparison and provides the sample size, overall PEDro score, and effect size estimates for individual studies (SMD, RR). Fourteen studies1,4,10,11,15,26,27,35,36,38,47,51,57,64 provided sufficient data for calculation of individual effect sizes (SMD, RR) for at least one of the key outcome measures. These values are provided in the right-hand columns, with a positive SMD or RR representing an effect in favor of the treatment group (for example, group A if the groups are compared as A versus B). Any significant differences between groups reported in the text are based on the P values (P < 0.05) provided in the original studies. Although it is evident that a number of studies carried out the same treatment comparisons, the effect sizes from individual trials could not be pooled for statistical analysis. This was due to heterogeneity of the study population, intervention mode and dosage, timing and type of outcome measures, or insufficient reporting of data. Ice Versus Heat/Contrast Bath. There was some evidence that cryotherapy was more effective than thermotherapy after ankle injury. A single study11 found that ice submersion with simultaneous exercises was significantly more effective than heat (SMD, 1.38; 95% CI, 0.35 to 2.29) and contrast therapy (SMD, 2.35; 95% CI, 1.13 to 3.37) plus simultaneous exercises, at reducing swelling between 3 and 5 days post ankle sprain. Ice Versus Ice and Electrical Stimulation. A single study47 compared the effect of ice alone to ice and simultaneous high-voltage electrical stimulation after acute ankle sprains. There was no significant difference when comparing ice alone and ice combined with low-frequency electrical stimulation (28 pulses per second) in terms of swelling (SMD, 0.47; 95% CI, 1.34 to 0.44), pain (SMD, 0.64; 95% CI, 1.51 to 0.28), and ROM (SMD, 0.69; 95% CI, 1.56 to

0.24). Similarly, there was no significant difference comparing ice alone and ice combined with higher frequency electrical stimulation (80 pulses per second) in terms of swelling (SMD, 1.39; 95% CI, 2.3 to 0.36), pain (SMD, 0.62; 95% CI, 1.5 to 0.31), and ROM (SMD, 1.36; 95% CI, 2.3 to 0.3). Ice Versus No Ice. Ice alone seems to be more effective than applying no form of cryotherapy after minor knee surgery. A single study36 compared the effect of an intermittent icing protocol combined with knee exercises to exercises alone, after minor arthroscopic knee surgery. The application of ice immediately before a rehabilitation program significantly decreased pain as measured by the affective component of the McGill Pain Questionnaire (SMD, 0.59; 95 CI, 0.02 to 1.17). The study also reported that subjects applying cryotherapy used significantly less prescription and nonprescription analgesia and had a significantly better weightbearing status; however, insufficient data are provided for the calculation of an effect size. In contrast, there were no significant differences between groups in terms of knee girth (SMD, 0.35; CI, 0.24 to 0.93) and knee ROM (SMD, 0.38; CI, 0.21 to 0.97) 1 week postsurgery. Ice (Continuous) Versus Ice (Intermittent). Using subjects post-CTR, Hochberg26 compared the effect of continuous cryotherapy to intermittent 20-minute ice applications over the first 3 postoperative days. Subjects applying continuous cryotherapy had a significantly greater decrease in pain (SMD, 1.09; CI, 0.4 to 1.7) and wrist circumference (SMD, 2.2; CI, 1.43 to 2.9) in comparison to those using cryotherapy intermittently. This was the only study to compare the effectiveness of two different cryotherapy protocols, and although it appears that continuous cryotherapy should be the treatment of choice after surgery, the modes of cryotherapy application were not consistent across the two groups. Ice and Compression Versus Ice and Compression. Four studies23,34,58,63 compared two different methods of applying simultaneous compression and cryotherapy, but few conclusions could be reached. Poor reporting of data meant that individual effect size could not be calculated for any of these studies. Furthermore, two studies58,63 did not provide adequate information on the mode of cryotherapy, and all failed to specify the duration and frequency of the ice application. Ice and Compression Versus No Ice. There is marginal evidence that a single simultaneous treatment with ice and compression is no more effective than no cryotherapy after an ankle sprain. Laba35 found that a single application of ice and compression, in addition to standard rehabilitation treatment (ultrasound, mobility, and proprioceptive exercises), produced similar levels of swelling (RR, 0.76; CI, 0.5 to 1.02) and pain immediately posttreatment (RR, 1.5; CI, 1.24 to 1.76) and at discharge (RR, 0.88; CI, 0.62 to 1.14) when compared to those receiving standard treatment only. Sloan59 also found that a single application of simultaneous ice and compression was as effective as no treatment in terms of reducing pain, swelling, and ROM post ankle sprain. Similarly, Edwards19 found that the con-

TABLE 5 Effect Size Estimates for Individual Studiesa

Effect size (95% CI) Injury Ankle11 Ankle11 Ankle47a 30 30 30 30 45 48 76 44 100 102 30 0.76 (0.51.02) N/A N/A N/A 0.35 (0.24 to 0.93) 2.2 (1.432.9) N/A N/A N/A 0.38 (0.21 to 0.97) N/A N/A N/A N/A 0.62 (1.5 to 0.3) (1.56 to 0.24) (day 1); (1.45 to 0.24) (day 3) (2.3 to 0.3) (day 1); (1.3 to 0.5) (day 3) 0.64 (1.51 to 0.28) Ankle Arth36
47b b

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Intervention 5 5 4 4 5 4 2 3 4 1 3 3 4

Function

Pain

Swelling

ROM

PEDro (10)

Ice vs heat Ice vs contrast Ice vs ice + E-Stim (Freq 28 pps) 1.38 (0.352.29) 2.35 (1.133.37) 0.47 (1.34 to 0.44) (day 1); 0.14 (1.01 to 0.75) (day 3) 1.39 (2.3 to 0.36) (day 1); 0.09 (0.96 to 0.8) (day 3) 0.69 0.58 1.36 0.39

Ice vs ice + E-Stim (Freq 80 pps)

Ice vs No Rx

Ice (continuous) vs ice (intermittent) CTR26 I/C vs I/C TKA23 ACL58 ACL34a Arth63 I/C vs No Rx Ankle35

I/C vs ice Ankle64a 34 TKA27 90 TKA57 24 ACL34b 100 19b ACL 63 ACL15 78 ACL1 ACL51a 99 21 0.89 (0.26 to 1.92)

Ankle59 ACL19a ACL10 143 63 54

I/C vs C (same mode)

0.39 (0.44 to 1.18) N/A N/A

4 3 4 5 4 4

1.14 (1.0; 1.28) 1.02 (0.16 to 2.05) 0.8 (0.27 to 1.9) (A/gesic)

3 1 4 4 5

I/C vs C (Diff Mode) Ankle64b TKA38 34 80

ACL51b THA57 LRR4 21 50 110

2 3

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I/C + P vs P vs I/C and I/A inj

TKA20 ACL6 60 50

0.24 (0.35 to 0.82) (T); 0.59 (0.02 to 1.17) (A) 1.09 (0.41.7) N/A N/A N/A N/A N/A 1.5 (1.241.76); 0.88 (0.621.14) N/A N/A N/A 4.43 (3.35.24); 4.49 (3.415.4) 0.14 (0.97 to 0.7) 0.43 (0.95 to 0.1) 0.75 (1.55 to 0.1) N/A N/A N/A N/A 0.33 (0.7 to 0.12) (VAS); 0.17 (0.6 to 0.3) (A/gesic); 0.09 (0.5 to 0.4) (IV) N/A 0.6 (1.64 to 0.5) (VAS); 0.3 (0.75 to 1.36) (A/gesic) 1.21 (0.02.2) (VAS) N/A Overall score: 0.35 (0.27 to 0.42) 0.55 (0.32 to 1.38) 0.75 (0.31.2) (VAS[D2]); 0.41 (0.04 to 0.85) (A/gesic) N/A N/A

0.64 (0.191.08) (day 7); 0.89 (0.421.34) (day 14) N/A

5 3 4

257

a Studies are grouped according to the treatment comparisons employed. A positive standardized mean difference or risk ratio represents an effect in favor of the treatment group (for example, group A if the groups are compared as A vs B). Effect size = relative risk ratio; ROM = range of movement; PEDro = Physiotherapy Evidence Database; Ankle = ankle sprain; = outcome not measured; E Stim = electrical stimulation; pps = pulses per second; No Rx = no treatment; T = total McGill Questionnaire score; A = affective component McGill questionnaire score; CTR = carpal tunnel release; I/C = simultaneous ice and compression; Same = mode of compression constant across groups; TKA = total knee arthroplasty; N/A = data not available; ACL = anterior cruciate ligament reconstruction; Arth = arthroscopy; I = ice treatment; C = compression; VAS = visual analogue scale; A/gesic = oral analgesic consumption; I/V = intravenous analgesic consumption; THA = total hip arthroplasty; Diff = mode of compression differed across groups; LRR = lateral retinacular release; P = placebo; I/A inj = intra-articular analgesic injection. b The superscripts a and b after the study reference number depict that a single study applied more than one cryotherapy protocol

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tinuous use of ice and compression had similar benefits to no treatment in terms of improving pain and ROM when applied postsurgically; however, insufficient data were provided for these later two studies.19,59 Ice and Compression Versus Ice. Only one clinical study has compared ice and compression to ice alone.10 The combination of treatments appeared to be significantly more effective than ice in terms of reducing the amount of intramuscular (SMD, 4.43; 95% CI, 3.3 to 5.24) and oral analgesia (SMD, 4.49; 95% CI, 3.4 to 5.4) administered postACL reconstruction. These results must be interpreted with caution, however, as the mode and duration of ice treatment were not controlled for across groups. Ice and Compression Versus Compression. The majority of included studies have tried to disentangle the effects of ice from compression by comparing a variety of treatment combinations. In four studies, it was difficult to compare the efficacy of each modality4,20,38,64 as the mode of compression differed between the intervention and control groups. On the contrary, eight studies strictly controlled for the type of compressive bandages used across comparison groups1,15,19,27,34,51,57,64; however, there seemed to be little difference in the effectiveness of ice and compression and compression alone. Wilkerson64 found no significant difference in the time of restricted activity after ankle sprain in subjects treated with compression alone and simultaneous ice and compression (SMD, 0.14; 95% CI, 0.97 to 0.7). Using subjects postACL reconstruction, others reported no significant differences between groups in terms of function,34 pain,19,34 and swelling1,19,34; however, insufficient data were reported and effect size could not be calculated for these outcomes. Similarly, Dervin15 found no significant differences in subjective pain scores (SMD, 0.33; 95% CI, 0.77 to 0.12) and the amounts of intravenous (SMD, 0.09; 95% CI, 0.53 to 0.35) and oral analgesics (SMD, 0.17; 95% CI, 0.62 to 0.27). In a group of subjects post-TKA, Ivey27 found no significant difference between groups with regard to the amount of injected morphine (SMD, 0.43; 95% CI, 0.95 to 0.1) postsurgery. Scarcella57 found no significant difference in subjects post-TKA in terms of ROM (SMD, 0.39; 95% CI, 0.44 to 1.18) and the time to independent ambulation (SMD, 0.75; 95% CI, 1.55 to 0.1). The study57 also reported that the analgesic consumption in each group was almost identical. Correspondingly, in a subgroup of patients recovering from total hip arthroplasty, Scarcella57 reported no significant differences in analgesic consumption postsurgery; however, insufficient data were provided and effect size could not be calculated. Only two studies reported significant differences between subjects treated with ice and compression and compression alone. Although Barber1 found no differences between groups in knee ROM after ACL reconstruction (RR, 1.14; 95% CI, 1.0 to 1.28), a significantly decreased analgesic consumption was reported in favor of the ice and compression group; however, inadequate data were provided. Again using subjects postACL reconstruction, Ohkoshi51 treated two groups with simultaneous ice and compression and a third with compression only. The ice and compression groups were cooled to slightly different

temperatures using a commercial ice machine (5C and 10C). Subjects using less extreme cooling (10C group) with concomitant compression had significantly lower subjective pain scores (SMD, 1.21; 95% CI, 0.00 to 2.2) and analgesic consumption (SMD, 0.88; 95% CI, 0.27 to 1.91) compared to those using compression alone. In contrast, there were no significant differences in subjects treated with simultaneous cooling (5C group) and compression and those treated with compression only in terms of subjective pain scores (SMD, 0.6, 95% CI, 1.64 to 0.5) and analgesic consumption (SMD, 0.3, 95% CI, 0.75 to 1.36). A better improvement in ROM was observed in the 5C (SMD, 1.02; 95% CI, 0.16 to 2.05) and 10C groups (SMD, 0.89; 95% CI, 0.26; 1.92) when compared to compression group; however, these differences were not significant. Therefore, despite eight trials comparing the effectiveness of ice and compression to compression alone, only two1,51 reported significant differences in favor of ice and compression. Both Barbers1 and Ohkoshi et al.s51 studies were of low quality, scoring just 1 out of 10 and 4 out of 10 on the PEDro scoring scale, respectively, and therefore the strength of their conclusions is limited. Generally, there was very little evidence to suggest that the addition of ice to compression has any significant effect. It must be noted, however, that all but one of the studies64 were undertaken postsurgery, and any conclusions are restricted to hospital inpatients with postsurgical wound dressings. Ice and Compression Plus Placebo Injection Versus Ice and Compression Plus Injection Versus Placebo Injection. Brandsson et al.6 found that ice and compression plus a placebo injection were significantly more effective than placebo injection alone at reducing postoperative pain. The addition of a pain-killing injection to ice and compression therapy significantly improved the analgesic effect further; however again, no data were provided and effect size could not be calculated.

DISCUSSION
Cryotherapy continues to be employed in both the clinical and sporting environments to treat acute soft-tissue injuries as well as postsurgical patients within a hospital setting.42 A number of review articles have advocated the use of cryotherapy in both of these contexts,31,41,42,55 and others have scrutinized its physiological and clinical effects.30,40,43,45,52,61 This is the first study to systematically review the literature, assessing the clinical evidence base supporting the use of cryotherapy based on the highest quality research evidence. The review is restricted to English language, however, and as the inclusion criteria for study population were broad, some of the information contained was difficult to compare and synthesize. The included randomized controlled trials scored an average PEDro score of only 3.4, and the contrast in treatment protocols means that comparison within and across studies is often impossible. Moreover, persistent methodological problems and the failure of the majority of studies to carry out a power analysis may prevent wider extrapolation of evidence.

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Soft-tissue injuries such as contusions, strains, and sprains are the most common injuries in Gaelic football,12 soccer,22 and rugby.21 To date, however, no randomized studies have assessed the efficacy of ice in the treatment of muscle contusions or strains, and only five studies have assessed the effect of ice on acute ankle sprains. Single applications of combined ice and compression seem to be as effective as no treatment after an acute sprain; however, these conclusions must be taken with caution. Aside from the paucity of high-quality studies undertaken, this particular research question may also be subject to a unique set of problems inherent to cryotherapy research. Given the strong empirical evidence base and the popularity of cryotherapy treatment with the layman, it may be difficult to randomize a subject to a no ice group. This is particularly evident in Labas35 study, in which 60% of subjects randomized to the no ice group had already applied ice as a self-treatment prior to recruitment. Evidence from a recent systematic review suggested that intermittent 10-minute ice treatments are most effective at cooling injured animal tissue and healthy human tissue.40 The effectiveness of this particular protocol has not yet been tested on injured human subjects; however, Hochberg26 found that intermittent 20-minute applications are less effective than continuous ice treatment after CTR surgery. The strength of the studys conclusions is greatly limited, however, as Hochberg26 crucially failed to control for the mode of cryotherapy across the continuous and intermittent groups. No individual study has rigorously compared the efficacy of different modes, durations, or frequencies of ice treatment, and preliminary recommendations for an optimal cryotherapy protocol cannot be made. Other systematic reviews5 have provided evidencebased guidelines on optimal treatment parameters by subgrouping trials to highlight a dose-dependant pattern. Although it was the authors intention to carry this out, subgrouping trials according to the mode or duration of cryotherapy was impossible due to clinical heterogeneity and the large number of trials supplying insufficient treatment detail. Within clinical practice, ice is commonly combined with compression and elevation, making it difficult to determine the value of cryotherapy alone.45,55,61 A number of studies have compared a wide range of combinations of ice and compression in a bid to try and disentangle their relative efficacy. Only one study10 compared simultaneous ice and compression to ice alone. This study does little to separate and quantify the individual effects of ice and compression as both the modes and durations of cold treatments applied across groups were starkly contrasting. Twelve studies compared the effectiveness of concomitant ice and compression to compression alone, but only eight well-controlled studies1,18,22,30,37,55,61,64 used the same mode of compression between intervention and control groups. The initial consensus seems to be that the addition of ice to compression is no more effective than compression alone. However, such a conclusion is limited, as in all eight of these studies, postsurgical dressings or socks were used to separate the injured area of the body and the cooling

device. The thickness of dressings varied from gauze57 to cast padding and an elastic bandage27; such barriers have the potential to mitigate the cooling effect of cold compress. To maximize the therapeutic effects of cryotherapy, an optimal tissue temperature reduction of 10 to 15C may be necessary.40 Skin temperature reductions to below 13.6C may be needed to achieve local analgesia,7 and perhaps lower tissue temperatures of between 10C and 15C may be required to maximally lower metabolism.33,56 Generally, the surface temperature of the cooling device and the subjects tissue temperature reduction during treatment were poorly reported in this review. The only study34 that monitored skin tissue temperatures during treatment reported a maximum reduction to just 28C. Correspondingly, there is evidence from many studies13,14,37,53 that it is difficult to achieve optimal tissue temperature reductions when cooling is applied over postoperative dressings. The interaction between the cooling surface and the subjects tissue is vital in determining the effectiveness of treatment and must be considered in future studies, particularly within a postsurgical environment. There have been some deleterious side effects of cryotherapy previously documented. A number of case studies have reported the occurrence of skin burns54 and nerve damage3,17,44,48 after as little as 20 to 30 minutes of cooling. Within this review, there was just one reported case of cold-induced nerve palsy, possibly caused by a continuous 40-minute ice application in the recovery room postsurgery.10 None of the other studies reported any incidences of skin burns or nerve palsies, despite applying continuous ice treatments for between 6 and 226 hours. Cryotherapy is a versatile modality and may be used in the immediate18,32,41,43,45,52,60 and rehabilitative31,55 phases of injury management. However, a common source of confusion is the basis for its application at each phase. Immediately postinjury, ice reduces tissue metabolism, thereby minimizing secondary hypoxic injury, cell debris, and edema. The sooner after injury cryotherapy is initiated, the more beneficial this reduction in metabolism will be.31 A number of studies35,47,59 began cryotherapy between 24 and 48 hours after injury and therefore may not have optimized this positive physiological effect. It may be easier to initiate early cryotherapy in studies using surgical patients. Although most surgical studies stated that cryotherapy was initiated either immediately after surgery, in the operating theatre, or after dressing and wound closure, few significant differences were reported. Again, this may be due to concomitant compression or wound bandaging mitigating the cooling effect and preventing adequate metabolic reduction. Outside the immediate stages of injury management, cryotherapy may be most effective when combined with exercise.31,32 Adequate cooling can reduce pain, spasm, and neural inhibition, thereby allowing for earlier and more aggressive exercises. In the current review, many studies1,10,20,26,27,34,38,57,58 continued cryotherapy treatment for days and even weeks after injury but chose not to integrate therapeutic exercise. Although cryotherapy in isola-

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tion may reduce the need for analgesics in the subacute phases of recovery, early exercise may be the most important component of treatment.31,32 Only two studies11,36 incorporated exercise with cryotherapy, during the subacute phases of recovery, and both recorded results significantly in favor of cryotherapy. Nonetheless, it seems that the majority of studies in this review have not fully considered the pathophysiological basis of cryotherapy and may not have used it to its full potential. Future studies must seek to optimize cryotherapys effects at each phase of injury management to provide clinicians with clearer evidence of its potential effectiveness and versatility.

CONCLUSION
Many more high-quality studies are needed to ensure that clinicians and sportsmen are following evidence-based guidelines in the treatment of acute soft-tissue injuries. Primarily, these must focus on developing modes, durations, and frequencies of ice application, which will optimize cryotherapy during immediate and rehabilitative care. Similarly, an optimal mode and duration of compression treatment must be highlighted. This evidence will highlight the respective value of each individual modality and if appropriate provide the basis of an optimal method for treatment combination. REFERENCES
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