effectiveness and safety of cryotherapy after arthroscopic anterior cruciate ligament...

Accepted Manuscript

Effectiveness and Safety of Cryotherapy after Arthroscopic Anterior CruciateLigament Reconstruction. A Systematic Review of the Literature

Ana Luiza Cabrera Martimbianco, Brenda Nazaré Gomes da Silva, Alan PedrosaViegas de Carvalho, Valter Silva, Maria Regina Torloni, Maria Stella Peccin

PII: S1466-853X(14)00012-1

DOI: 10.1016/j.ptsp.2014.02.008

Reference: YPTSP 601

To appear in: Physical Therapy in Sports

Received Date: 18 October 2013

Revised Date: 25 January 2014

Accepted Date: 27 February 2014

Please cite this article as: Martimbianco, A.L.C., Gomes da Silva, B.N., de Carvalho, A.P.V., Silva, V.,Torloni, M.R., Peccin, M.S., Effectiveness and Safety of Cryotherapy after Arthroscopic Anterior CruciateLigament Reconstruction. A Systematic Review of the Literature, Physical Therapy in Sports (2014), doi:10.1016/j.ptsp.2014.02.008.

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http://dx.doi.org/10.1016/j.ptsp.2014.02.008

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TITLE PAGE

Effectiveness and Safety of Cryotherapy after Arthr oscopic Anterior

Cruciate Ligament Reconstruction. A Systematic Revi ew of the Literature

Ana Luiza Cabrera Martimbiancoa

Brenda Nazaré Gomes da Silvaa

Alan Pedrosa Viegas de Carvalhoa

Valter Silvaa

Maria Regina Torlonia

Maria Stella Peccina

aAuthors' affiliation address:

Department of Internal Medicine, Federal University of Sao Paulo

Rua Botucatu, 740

Postal Code: 04023-900

São Paulo/SP

Brazil

Corresponding author:

Ana Luiza Cabrera Martimbianco

E-mail: [email protected]

Tel/Fax: + 55 (11) 5575 2970

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Effectiveness and Safety of Cryotherapy after Arthroscopic Anterior 1

Cruciate Ligament Reconstruction. A Systematic Review of the Literature 2

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ABSTRACT 24

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Cryotherapy is widely used in rehabilitation; however, its effectiveness 26

after anterior cruciate ligament (ACL) reconstruction remains uncertain. To 27

investigate the effectiveness and safety of cryotherapy following ACL 28

reconstruction through a systematic review, randomized and quasi-randomized 29

clinical trials were searched in the databases: MEDLINE, EMBASE, CENTRAL, 30

PEDro, SportDiscus, CINAHL, LILACS (June 2013). The primary outcomes 31

measures were pain, edema and adverse events; the secondary outcomes 32

were knee function, analgesic medication use, range of motion, blood loss, 33

hospital stay, quality of life and patient satisfaction. The methodological quality 34

of studies was evaluated using the Cochrane Collaboration risk of bias tool. Ten 35

trials (a total of 573 patients) were included. Results of meta-analysis showed 36

that the use of cold compression devices produced a significant reduction in 37

pain scores 48 hours after surgery (p < 0.00001), compared to no cryotherapy. 38

The risk for adverse events did not differ between patients receiving 39

cryotherapy versus no treatment (p = 1.00). The limited evidence currently 40

available is insufficient to draw definitive conclusions on the effectiveness of 41

cryotherapy for other outcomes. There is a need for well designed, good quality 42

randomized trials to answer other questions related to this intervention and 43

increase the precision of future systematic reviews. 44

Key words: Anterior Cruciate Ligament, Anterior Cruciate Ligament 45

Reconstruction, Cryotherapy, Cold therapy. 46

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INTRODUCTION 47

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Rupture of the anterior cruciate ligament (ACL) of the knee is currently 49

one of the most common musculoskeletal injuries related to sports activities, 50

with an estimated 200,000 new cases per year in the United States (Gianotti, 51

Marshall, Hume, & Bunt, 2009; Siegel, Vandenakker-Albanese, & Siegel, 2012). 52

Arthroscopic ACL reconstruction surgery is the gold standard for treating ACL 53

tears (Adams, Logerstedt, Hunter-Giordano, Axe, & Snyder-Mackler, 2012; 54

Lobb, Tumilty, & Claydon, 2012). However, the postoperative period is generally 55

associated with important clinical symptoms, including local pain, edema and 56

reduced knee range of motion, which delay functional recovery time (van 57

Grinsven, van Cingel, Holla, & van Loon, 2010; Yabroudi & Irrgang, 2013). 58

The use of ice, or cryotherapy, is an easily available, low-cost and 59

popular intervention that has been widely used for acute musculoskeletal 60

injuries. Cold reduces cellular metabolism, nerve conduction, edema formation 61

and pain, thus helping injured tissues to recover (Nadler, Weingand, & Kruse, 62

2004; Ho, Coel, Kajawa, & Richardson, 1994; Warren, McCarty, Richardson, 63

Michener, & Spindler, 2004). Cold has also been used in post-operative 64

patients. By relieving acute symptoms including pain and edema, cryotherapy is 65

believed to accelerate postoperative rehabilitation and the return to regular 66

activities. Several studies have tested the effects of cryotherapy in the relief of 67

post-operative pain after knee surgery (Martin, Spindler, Jeremy, Tarter, 68

Detwiler, & Petersen, 2001; Glenn, Spindler, Warren, McCarty, & Secic, 2004; 69

Lessard, Scudds, Amendola & Vaz, 1997; Woolf, Barfield, Merrill, & McBryde, 70

2008). It has been hypothesized that this effect may be due to decreased 71

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release of inflammatory mediators, such as prostaglandin E2, in the synovial 72

membranes (Stålman, Berglund, Dungnerc, Arner, & Felländer-Tsai, 2011). 73

Cold therapy can be applied through different methods, including cold 74

packs, ice massages, crushed-ice bags and cold compression devices. Up to 75

the present, there is no consensus on which of these methods is most effective, 76

nor on what is the ideal duration of therapy or whether it should be used 77

intermittently or continuously (Dykstra, Hill, Miller, Cheatham, Michael, & Baker, 78

2009; Warren et al., 2004; Wilke & Weiner, 2003; Rupp, Herman, Hertel, & 79

Saliba, 2012). The safety of cryotherapy also needs to be considered, since ice 80

can lead to skin burns (frostbite) and superficial nerve paralysis, as well as 81

urticarial reactions and Raynaud’s phenomenon (Nadler et al., 2004; McGuire & 82

Hendricks, 2006). 83

In 2005, a systematic review concluded that cryotherapy was effective in 84

reducing post-operative pain after ACL reconstruction (Raynor, Pietrobon, 85

Guller, and Higgins, 2005). Since more trials have been published over the last 86

years, we decided to update, critically appraise and synthesize the existing 87

evidence on the effectiveness and safety of cryotherapy following arthroscopic 88

ACL reconstruction. This review will help to inform the clinical decisions of 89

patients and physicians and to map existing controversies and research gaps in 90

this area. 91

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METHODS 93

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This systematic review was conducted according to the 95

recommendations of the Cochrane Collaboration (Higgins & Green, 2011) and 96

the PRISMA reporting guidelines (Moher, Liberati, Tetzlaff, & Altman, 2010). 97

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Eligibility criteria 99

Types of studies: Randomized and quasi-randomized controlled trials 100

(e.g. allocation by patient record number, date of birth). 101

Participants: Skeletally mature patients (≥ 18 years old) submitted to 102

primary ACL arthroscopic reconstruction. Studies including patients with 103

bilateral ACL reconstruction, re-rupture or concurrent knee ligament surgery 104

were excluded. 105

Interventions: Any type of cold application around the knee (e.g. ice 106

packs, cooling pads or cold compression devices) compared to any control 107

group (e.g. placebo, no cold therapy, different types of cold therapy, other 108

clinical interventions – pharmacological or not). A cold compression device 109

(CCD) is a cooling system that consists of a reservoir filled with cold water that 110

is connected to two rubber plates or braces, via a rubber hose, which 111

completely involves the joint. The cold water circulates through the hose to the 112

knee and temperature is controlled by the device’s control system (Nadler et al., 113

2004). 114

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Outcome measures 116

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Primary outcomes: (1) Pain intensity (measured by e.g. visual analogue 117

scale (VAS)), (2) Edema (e.g. knee circumference measured using tape) and 118

(3) Adverse events (thermal injury, such as burn, transient nerve palsy). 119

Secondary outcomes: (1) Function measured by knee scores (e.g. 120

Lysholm score, IKDC score); (2) Post-operative analgesic medication use; (3) 121

Knee range of motion; (4) Blood loss (as measured from the intra-articular drain 122

before removal); (5) Length of hospital stay; (6) Quality of life measures (e.g. 123

SF-36 questionnaire); (7) Patient satisfaction. 124

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Search strategy 126

The following databases were searched: MEDLINE (via Pubmed, 1966 to 127

June 2013); EMBASE (via Elsevier, 1980 to June 2013); Cochrane Central 128

Register of Controlled Trials (The Cochrane Library, Issue 5, 2013); PEDro 129

(1999 to June 2013); SportDiscus (1985 to June 2013); CINAHL (1982 to June 130

2013) and Literature of Latin America and the Caribbean: LILACS (1982 to June 131

2013). We also searched ClinicalTrials.gov for ongoing and recently completed 132

trials. No restrictions were placed on language of publication. The search was 133

complemented by screening the reference lists of the retrieved articles. 134

The search strategies were based on the strategy developed for 135

MEDLINE (via Pubmed), combined with the high-pass sensitivity filter 136

developed by the Cochrane Collaboration (Higgins & Green, 2011) to identify 137

randomized controlled trials. The following search terms were used: “Anterior 138

Cruciate Ligament” OR “Anterior Cruciate Ligament Reconstruction” OR “Bone-139

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Patellar Tendon-Bone Graft” OR “Arthroscopy”, AND “Cryotherapy” OR “Cold 140

Therapy” and related terms adapted for each database (Appendix). 141

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Study selection 143

Two reviewers (ALCM and BNGS) independently screened the titles and 144

abstracts retrieved through the search strategy. The full texts of all studies 145

considered potentially relevant were obtained and read independently by the 146

same two reviewers. The studies fulfilling the aforementioned selection criteria 147

were included in the review. Disagreements between the two reviewers were 148

settled by a third reviewer (MSP). 149

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Data Extraction 151

Two independent reviewers (ALCM and VS) extracted data from all 152

included studies using a standardized extraction form especially created for this 153

review. The form collected information on participants, methodological aspects 154

of the study, interventions, outcomes and results. The two individual forms were 155

discussed by the reviewers until consensus was reached and merged into a 156

single extraction form. Persistent disagreements were settled by a third 157

reviewer (MSP). When necessary, authors of the included studies were 158

contacted for further information. 159

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Assessment of risk of bias in individual studies 161

Two reviewers (ALCM and APVC) independently assessed the 162

methodological quality of the included studies using The Cochrane 163

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Collaboration’s risk of bias tool (Higgins & Green, 2011). This tool assesses 7 164

study domains: sequence generation, allocation concealment, blinding of 165

participants, personnel and outcome assessors, incomplete outcome data, 166

selective reporting and other sources of bias. Each of these domains was 167

classified by the reviewers as being at high, low or unclear risk of bias. 168

Disagreements between the two reviewers were settled by a third reviewer 169

(MSP). 170

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Quantitative Data Synthesis and Analysis 172

Measures of treatment effect 173

For dichotomous outcomes, results were reported using risk ratio (RR) or 174

risk difference (RD). Outcomes presented as continuous data were reported 175

using mean difference (MD); if different scales were used to measure the same 176

outcome, standardized mean difference (SMD) was used. The 95% confidence 177

interval was calculated for all reported outcomes. If continuous outcome data 178

were not reported and contacting trial authors was not successful, standard 179

deviations were calculated using available standard errors, p-values or 95% 180

confidence intervals. Data presented only in graphs were extracted using the 181

“Digitizelt” software (available from: http://www.digitizelt.de/). Whenever 182

possible, meta-analyses were performed. (Higgins & Green, 2011; Levy, 183

Hubbard, & Eisenberg, 2009) using a review manager software (RevMan, 184

Version 5.2, The Nordic Cochrane Centre, Copenhagen, The Cochrane 185

Collaboration, 2011). 186

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Assessment of heterogeneity 188

Heterogeneity was assessed by visual inspection of the forest plots and 189

by using the I2 statistical test in fixed-effect meta-analyses; I2 values > 50% 190

were interpreted as indicative of significant heterogeneity. The Tau2 statistical 191

test was used in random-effect meta-analyses: results > 1 were interpreted as 192

being suggestive of substantial statistical heterogeneity. Statistical significance 193

(P < .10) was also assessed. When heterogeneity was detected, possible 194

reasons were investigated and reported. (Higgins & Green, 2011) 195

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RESULTS 197

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The electronic search resulted in a total of 341 references which were 199

reduced to 255 after the exclusion of duplicates. At first screening (titles and 200

abstracts) 239 studies were excluded because they were outside the scope of 201

this review and 16 were selected as potentially relevant. After reading these 16 202

full-texts, 6 studies were excluded (5 because of different participant selection 203

criteria (Fang, Hung, Wu, Fang, & Stocker, 2012; Zaffagnini, Iacono, Petitto, 204

Loreti, Fu, & Marcacci, 1998; Ling-li, Ning, Xiao-ling, Hong, Jia-li, & Zhong-lan, 205

2010; Lessard et al., 1997; Whitelaw, DeMuth, Demos, Schepsis, & Jacques, 206

1995) and 1 due to study design (Daniel, Stone, Arendt, 1994)) and 10 studies 207

were included in the review (FIGURE 1). 208

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Characteristics of included studies 210

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Table 1 presents the main characteristics and results of the studies 211

included in the review. The 10 studies included recruited a total 573 212

participants. Seven were randomized clinical trials (Edwards, Rimmer, & Keene, 213

1996; Konrath, Lock, Goitz, & Scheidler, 1996; Brandsson, Rydgren, Hedner, 214

Eriksson, Lundin, Sward, & Karlsson, 1996; Cohn, Draeger, & Jackson, 1989; 215

Schröder & Pässler, 1994; Dambros, Martimbianco, Polachini, Lahoz, 216

Chamlian, & Cohen, 2012; Waterman, Walker, Swaims, Shortt, Todd, Machen, 217

& Owens, 2012) and three were quasi-randomized clinical trials (Dervin, Taylor, 218

Keene, 1998; Ohkoshi, Ohkoshi, Nagasaki, Ono, Hashimoto, & Yamane, 1999; 219

Barber, McGuire, & Click, 1998). All studies involved patients diagnosed with 220

ACL rupture who underwent arthroscopic ACL reconstruction and were treated 221

with cryotherapy in hospital settings during the post-operative period, before 222

discharge. In two studies (Waterman et al., 2012; Barber et al., 1998) the 223

participants were instructed to continue cryotherapy after discharge for a total of 224

6 weeks and 1 week, respectively. 225

Most of the participants were men (69%) with a mean age ranging from 226

22 to 34 years. One study (Dambros et al., 2012) compared the use of knee ice 227

packs versus no treatment, while the other nine studies reported the use of a 228

cold compression device (CCD) versus ice packs (Cohn et al., 1989; Konrath et 229

al., 1996; Schröder & Pässler, 1994; Waterman et al., 2012), CCD versus 230

placebo (CCD filled with water at room temperature) (Konrath et al., 1996; 231

Edwards et al., 1996; Konrath et al., 1996) and CCD versus no cold therapy 232

(Konrath et al., 1996; Edwards et al., 1996; Brandsson et al., 1996; Ohkoshi et 233

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al., 1999; Barber et al., 1998). All the authors reported that occlusive dressings 234

had been used on the surgical incision prior to applying the cooling device. 235

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Assessment of risk of bias 237

The methodological quality of the 10 studies is described in Figure 2. We 238

contacted the authors of all 10 studies via e-mail to clarify details related to the 239

risk of bias and to obtain additional information; only four authors responded 240

(Dervin et al., 1998; Ohkoshi et al., 1999; Waterman et al., 2012; Dambros et 241

al., 2012). Three studies (Dervin et al., 1998; Ohkoshi et al., 1999; Barber et al., 242

1998) were quasi-randomized trials (patients were allocated according to the 243

number of their medical record or date of birth) and were categorized as being 244

at high risk of bias for two domains — random sequence generation and 245

allocation concealment (risk of selection bias). All trials were classified as being 246

at high risk of bias for blinding of participants and personnel because, given the 247

nature of the intervention, patients could not be blinded, thus introducing 248

potential bias. Two studies (Dervin et al., 1998; Dambros et al., 2012) were 249

classified as having an unclear risk of bias for incomplete outcome data 250

reporting because they did not provide information on excluded participants. 251

This fact may cause imbalance between the groups thus influencing the results. 252

Based on the recommendations of the Cochrane Collaboration, all 10 studies 253

were judged to be at high risk of bias because at least one of the first three 254

domains were scored as being at high risk of bias (Higgins & Green, 2011). 255

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Effects of interventions (Quantitative analysis) 257

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Continuous outcomes 258

Given the lack of data and the unsuccessful contact with trial authors, we 259

were able to obtain outcome data for pooling in meta-analyses from only two 260

studies (Brandsson et al., 1996; Ohkoshi et al., 1999) which reported one of our 261

primary outcomes (pain intensity). These two studies compared the use of a 262

cold compression device (CCD) versus no cold therapy. Pooling of results 263

indicated a significant reduction in pain intensity (VAS pain score 48 hours after 264

ACLR) in the group receiving the intervention: mean difference (MD) -1.41, 95% 265

CI -1.66 to -1.17, p < 0.00001], with low heterogeneity (Figure 3). 266

Results of the outcomes that could not be pooled in a meta-analysis 267

(individual clinical trials) are described in Table 1. Edwards et al., (1996), 268

Barber et al., (1998) and Konrath et al., (1996) reported no statistical 269

differences with or without cold therapy for pain intensity. When comparing CCD 270

with cold water against CCD with room temperature water (placebo), Dervin et 271

al., (1998), Edwards et al., (1996) and Konrath et al., (1996) did not find 272

statistically significant differences for the pain measured 24 and 48 hours after 273

ACL reconstruction. Two studies which compared the use of CCD versus ice 274

pack reported significant improvement favoring CCD after the 1st week (p < 275

0.01) (Schröder & Pässler, 1994) and after 6 weeks after surgery (p < 0.0001) 276

(Waterman et al., 2012). 277

Despite the difficulty in comparing the different drugs prescribed in each 278

study, the same clinical trials (Cohn et al., 1989; Ohkoshi et al., 1999; Barber et 279

al., 1998; Schröder & Pässler, 1994; Waterman et al., 2012; Brandsson et al., 280

1996) that reported improvement in pain intensity, also showed a statistically 281

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significant reduction in the amount of medication taken by the patients after the 282

use of CCD, when compared to both ice pack and control (no cold therapy). 283

Three studies assessed knee edema (Waterman et al., 2012; Schröder & 284

Pässler, 1994; Barber et al., 1998) and only one (Schröder & Pässler, 1994) 285

reported a small but statistically significant improvement in this outcome in 286

patients using CCD compared to those randomized to receive ice packs 287

(p<0.035). Among the studies that assessed the amount of blood drained after 288

surgery (Schröder & Pässler, 1994; Edwards et al., 1996; Konrath et al., 1996; 289

Ohkoshi et al., 1999; Dervin et al., 1998), only Ohkoshi et al., (1999) reported 290

significant reduction in the volume of blood drained immediately after surgery 291

(48 hours) with the use of CCD at 5°C, compared to CCD at 10°C and no 292

cryotherapy (control group) (p <0.01). 293

Five studies assessed knee range of motion (Schröder & Pässler, 1994; 294

Dambros et al., 2012; Barber et al., 1998; Edwards et al., 1996; Konrath et al., 295

1996) and only one (Schröder & Pässler, 1994) reported statistically significant 296

results favoring the intervention group (CCD) versus ice pack group (p < 0.01). 297

Schröder & Pässler, (1994) and Waterman et al., (2012) evaluated knee 298

function. Only Schröder & Pässler, (1994) reported a small but statistically 299

significant improvement favoring the CCD group when compared to the ice pack 300

group (p < 0.025). Brandsson et al., (1996) analyzed patient satisfaction and 301

reported a statistically significant difference in favor of the CCD group when 302

compared with no treatment (p < 0.05). The individual clinical trials did not 303

detect significant differences in duration of hospital stay (Edwards et al., 1996; 304

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Konrath et al., 1996; Cohn et al., 1989; Brandsson et al., 1996; Dervin et al., 305

1998) and quality of life (Waterman et al., 2012). 306

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Dichotomous outcomes 308

All the included studies assessed the safety of cryotherapy by evaluating 309

the occurrence of adverse events. Only one study (Cohn et al., 1989), that 310

compared the use of a cold compression device (CCD) versus ice pack, 311

reported the occurrence of transient peroneal nerve palsy in one patient who 312

received the ice pack. Results of meta-analysis for adverse events showed no 313

statistically significant difference between comparison groups: CCD versus ice 314

pack (risk difference (RD) -0.01, 95% CI -0.06 to 0.04, p = 0.66); CCD versus 315

no treatment (risk difference (RD) -0.00, 95% CI -0.04 to 0.04, p = 1.00) and 316

CCD versus CCD placebo (risk difference (RD) -0.01, 95% CI -0.06 to 0.04, p = 317

0.66). 318

DISCUSSION 319

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Cryotherapy after arthroscopic anterior cruciate ligament (ACL) 321

reconstruction significantly reduced immediate post-surgery pain and did not 322

increase the risk of adverse events, in the short-term (up to 48 hours after 323

surgery). The limited evidence currently available from randomized trials is 324

insufficient to draw definitive conclusions on the effectiveness of cryotherapy for 325

other outcomes such as edema, knee function, postoperative blood loss, 326

duration of hospital stay, range of motion, post-operative analgesic medication 327

use, patient satisfaction or quality of life. Observational studies suggest that 328

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cryotherapy may produce immediate benefits by reducing pain and edema 329

during the inflammatory response after surgery, decreasing muscle spasm and 330

improving knee function, thereby accelerating the postoperative rehabilitation 331

and the return to routine activities. (Rashkovska, Trobec, Avbelj & Veselko, 332

2013; Dykstra, Hill, Miller, Cheatham, Michael, & Baker, 2009; Osbahr, Cawley, 333

& Speer, 2002) 334

Our meta-analysis indicates that CCD, compared to no cold therapy, 335

leads to a significant reduction in knee pain measured 48 hours after 336

arthroscopic ACL reconstruction (p < 0.00001). Based on the existing evidence, 337

it was not possible to determine what are best type, frequency and duration of 338

cryotherapy to reduce pain after ACL reconstruction. The use of CCD can 339

reduce pain by compression or by cold therapy; therefore it is difficult to 340

separate the actual effects of each component. Some investigators question the 341

effectiveness of the compression produced by CCD, claiming that it might not 342

have much influence on pain relief as the cooling itself (Dervin et al., 1998; 343

Morsi, 2002; Raynor et al., 2005). 344

Knee edema can also be influenced by cryotherapy associated with 345

compression (Kullenberg, Ylipää, Söderlund, & Resch, 2006; Morsi, 2002). 346

Some investigators consider this outcome as somewhat subjective, since it is 347

difficult to obtain a precise measurement of the edema (Dervin et al., 1998; 348

Edwards et al., 1996); this could help to explain the lack of data on this 349

outcome. Low temperatures might reduce post-surgery blood loss, thus helping 350

to reduce swelling (Adie, Kwan, Naylor, Harris, & Mittal, 2012). 351

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All the included studies investigated the occurrence of adverse events 352

related to cold therapy. The results from the meta-analysis indicate that cold 353

therapy after ACL reconstruction is safe. Cohn et al., (1989) reported that one 354

patient in the ice pack group developed transient peroneal nerve palsy, after the 355

pack had been left in place for nearly 40 minutes. According to these authors, 356

this type of complication could be avoided by using ice packs for no longer than 357

30 minutes and by protecting superficial nerves with knee bandages prior to 358

applying the intervention. 359

The evidence provided partial answers to the core questions raised in 360

this review. In most trials, assessment of outcomes was limited to a short 361

period, between 24 to 48 hours after surgery. Only one study (Waterman et al., 362

2012) assessed results of the intervention in the long term (6 weeks after the 363

surgery). 364

A recent systematic review assessed the effectiveness of cryotherapy 365

after total knee arthroplasty, and reported that it is associated with a small but 366

statistically significant reduction in pain and blood loss, as well as improvement 367

in the range of motion (Adie et al., 2012). As in the present study, the authors of 368

that review noted methodological limitations in the included studies, which could 369

have influenced most of the outcomes assessed. According to a systematic 370

review on cryotherapy for acute soft tissues injuries (Bleakley, McDonough, & 371

MacAuley, 2004), there was small but statistically significant effect of 372

compression combined with cryotherapy (CCD) compared to ice packs. 373

However, as in our review, the studies included in that review were limited to 374

interventions carried out before hospital discharge. Those authors recommend 375

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caution when interpreting the results due to the heterogeneity and poor 376

methodological quality of the included studies. 377

A similar review was published by Raynor et al., (2005) eight years ago 378

and, in concordance with our findings; it concluded that cryotherapy after ACL 379

surgery significantly reduced immediate post-surgery pain, without significant 380

improvement in postoperative blood loss or range of motion. However, there are 381

several differences between our reviews. Raynor et al., (2005) included only 382

seven studies and 420 participants, while we included ten studies and 573 383

participants. Although two studies included in our review were published 384

recently (Dambros et al., 2012; Waterman et al., 2012), we also included two 385

studies which had already been published at the time of that previous review 386

(Cohn et al., 1989; Schröder & Pässler, 1994) but were not included by those 387

authors. This was in part due to our more sensitive search and to the fact that 388

we ran our search in three additional electronic databases that had not been 389

included by those investigators (EMBASE, LILACS and PEDro). Due to different 390

selection criteria, our review excluded one study (Daniel et al., 1994) which was 391

included by Raynor et al., (2005). Contrary to Raynor´s review, we assessed 392

the methodological quality (risk of bias) of the included studies which is an 393

important step in systematic reviews of the literature (Higgins & Green, 2011). 394

Finally, besides the outcomes evaluated by Raynor et al., (2005) (pain, 395

postoperative drainage and range of motion), our review included additional 396

clinically relevant outcomes such as knee edema and function, use of post-397

operative analgesics, length of hospital stay, quality of life, patient satisfaction, 398

and safety of cryotherapy. 399

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All studies included in our review were at high risk of bias, recruited a 400

small number of participants and provided sparse data on most of our pre-401

established outcomes of interest, thus precluding pooling of their results into 402

meta-analyses. These studies were heterogeneous in several aspects: they 403

compared different forms of cryotherapy (Cold Compression Device (CCD) x ice 404

pack; CCD x CCD placebo (with water at room temperature); CCD x no cold 405

therapy; ice pack x no cold therapy), different frequencies and durations of 406

sessions, and different follow-up periods. The main methodological limitations of 407

the included studies were the lack of description of random sequence 408

generation and allocation concealment, as well as difficulties in blinding of 409

participants and outcome assessors due to the nature of the intervention. This 410

may in part be explained by the fact that most of these studies (8 /10) were 411

published in the 80s and 90s, a period when most trials did not follow the 412

internationally accepted standard recommendations for reporting clinical trials 413

(CONSORT -Consolidated Standards of Reporting Trials) and did not have 414

published protocols. We admit the possibility that relevant studies may have 415

been missed, despite our rigorous and ample search strategy without language 416

or date restrictions. Another potential limitation of this review is the lack of 417

success in obtaining additional information from the trial authors, precluding 418

additional meta-analyses. According to GRADE system (The Grades of 419

Recommendation, Assessment, Development and Evaluation Working Group) 420

(Higgins & Green, 2011), the general analysis of the quality of the evidence 421

(internal validity) was moderate, since most information was obtained from 422

studies that presented “unclear risk of bias”. 423

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424

CONCLUSION 425

426

There is moderate quality evidence that cryotherapy is safe and effective 427

in reducing pain after ACL reconstruction, in the first 48 hours after surgery. The 428

limited evidence currently available is insufficient to draw definitive conclusions 429

on the effectiveness of this intervention for other important outcomes, such as 430

knee edema and function, use of post-operative analgesic medication, knee 431

range of motion, blood loss, duration of hospital stay, quality of life measures 432

and patient satisfaction. There is a need for more, well designed, good quality 433

randomized trials to answer several remaining questions related to this 434

intervention and increase the precision of future systematic reviews. 435

436

Ethical Approval 437

This study was approved by the Ethics Committee of Federal University 438

of Sao Paulo (CEP 0142/11). 439

440

Funding 441

There are no sources of funding. 442

443

Conflict of interest 444

The authors have no conflicts of interest or financial support to declare 445

(including research funding) or involvement with any commercial organization 446

that has a direct financial interest in any matter included in this manuscript. 447

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448

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ACCEPTED MANUSCRIPTAPPENDIX

Search strategies

MEDLINE (via Pubmed)

#A ("Anterior Cruciate Ligament"[Mesh]) OR (Cruciate Ligament, Anterior) OR (Anterior Cruciate Ligaments) OR (Cruciate Ligaments, Anterior) OR (Ligament, Anterior Cruciate) OR (Ligaments, Anterior Cruciate) OR (Anterior Cruciate Ligament Injury) OR (Anterior Cruciate Ligament Injuries) OR (Anterior Cruciate Ligament Repair) OR (Anterior Cruciate Ligament Tears) OR (“Anterior Cruciate Ligament Reconstruction”[Mesh]) OR ("Bone-Patellar Tendon-Bone Graft"[Mesh]) OR (Bone Patellar Tendon Bone Graft) OR (Bone-Patellar Tendon-Bone Grafts) OR (Graft, Bone-Patellar Tendon-Bone) OR (Grafts, Bone-Patellar Tendon-Bone) OR ("Knee"[Mesh]) OR Knees OR ("Knee Joint"[Mesh]) OR (Joint, Knee) OR (Joints, Knee) OR (Knee Joints) OR ("Knee Injuries"[Mesh]) OR (Knee injuries) OR (Knee Injury) OR (Injuries, Knee) OR (Injury, Knee) OR (Knee Instability) OR (Knee Reconstruction) OR (Knee Repair) OR (Knee Damage) OR (Knee Impingement) OR (Knee Ligament Injury) OR (Acutely Injured Knee) OR (Cruciate Knee Surgery) OR ("Arthroscopy"[Mesh]) OR Arthroscopies OR (Arthroscopic Surgical Procedures) OR (Arthroscopic Surgical Procedure) OR (Procedure, Arthroscopic Surgical) OR (Procedures, Arthroscopic Surgical) OR (Surgical Procedure, Arthroscopic) OR (Surgery, Arthroscopic) OR (Surgical Procedures, Arthroscopic) OR (Arthroscopic Surgery) OR (Arthroscopic Surgeries) OR (Surgeries, Arthroscopic) OR (Arthroscopic Lateral Retinacular Release) OR (Knee Joint Arthroscopy) OR (Knee Joint Arthroscopies) OR (Arthroscopic Knee Surgery) OR (Arthroscopic Knee Surgeries) OR (Knee Arthroscopy) OR (Knee Arthroscopies) #B ("Cryotherapy"[Mesh]) OR Cryotherapies OR (Therapy, Cold) OR (Cold Therapies) OR (Therapies, Cold) OR (Cold Therapy) OR (Ice Therapy) OR (Ice Therapies) OR (Cubed Ice) OR (Crushed Ice) OR (Ice Packs) OR (Ice Pack) OR (Cold Packs) OR (Ice Bag) OR (Ice Bags) OR (Cold Pack) OR (Cooling Pads) OR (Cooling Pad) OR (Cold Compression) OR (Cooled Water) OR (Cold Bags) OR (Cold Bag) OR (Cold Gel Packs) OR (Ice Massage) OR (Cold Water) OR (Ice Bath) OR (Cold Gel) OR (Cold Therapy Gel) OR (Cold Application) OR (Cold Applications) OR (Cold Water Immersion) OR (Cryokinetic) OR (Cryotherapeutic Agents) OR (Local Cooling) OR (Therapeutic Cooling) OR (Continuous Cryotherapy) OR (Cryocuff) OR (Thermal Therapy) OR (Cryotherapy Device) OR Hypothermia OR Thermotherapy OR (Continuous Flow Cold Therapy) OR (Ice Pack Therapy) OR (Cold Gel Pack) OR (Cold Compressive Dressing) OR (Cold Compressive Devices) OR (Thermal Modalities) OR (Ice Treatment) OR (Chipped Ice) OR (Ice Machines) OR (Ice Submersion) OR (Wetted Ice) #C ((randomized controlled trial [pt]) OR (controlled clinical trial [pt]) OR (randomized [tiab]) OR (placebo [tiab]) OR (drug therapy [sh]) OR (randomly [tiab]) OR (trial [tiab]) OR (groups [tiab])) AND (humans [mh]) EMBASE (via Elsevier) #1 'anterior cruciate ligament'/exp OR ‘anterior cruciate knee ligament’ OR ‘anterior cruciate ligament knee’ OR ‘cruciate knee ligament anterior’ OR ‘ligament anterior cruciate knee’ OR 'anterior cruciate ligament reconstruction'/exp OR 'ACL reconstruction' OR 'ACL repair' OR 'ACL surgery' OR 'anterior cruciate ligament repair' OR 'anterior cruciate ligament surgery' OR 'bone patellar tendon bone graft'/exp OR bone-patellar tendon-bone graft OR 'knee'/exp OR 'articulatic genus'/exp OR 'genopathy'/exp OR 'joint knee'/exp OR 'knee compartment'/exp OR 'knee joint'/exp OR 'knee movement'/exp OR 'knee stiffness'/exp OR 'knee injury'/exp OR 'injury knee'/exp OR 'knee injuries'/exp OR 'knee joint injury'/exp OR 'knee joint trauma'/exp OR 'knee open injury'/exp OR 'knee trauma'/exp OR 'trauma knee'/exp OR 'soft tissue injury'/exp

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ACCEPTED MANUSCRIPTOR 'soft tissue injuries'/exp OR 'soft tissue trauma'/exp OR 'soft tissue wound'/exp OR 'arthroscopy'/exp OR 'arthroendoscopy'/exp OR 'arthroscopic procedure'/exp OR 'arthroscopic procedures'/exp #2 'cryotherapy'/exp OR ‘bath cold’ OR ‘bath hypothermal’ OR ‘cold bath’ OR ‘cold therapy’ OR ‘cryogenic therapy’ OR ‘cryothermy’ OR ‘cryotreatment’ OR ‘therapy cryogenic’ CENTRAL

#1 MeSH descriptor Anterior Cruciate Ligament explode all trees #2 MeSH descriptor Anterior Cruciate Ligament Reconstruction explode all trees #3 MeSH descriptor Knee explode all trees #4 MeSH descriptor Knee Joint explode all trees #5 MeSH descriptor Knee Injuries explode all trees #6 MeSH descriptor Arthroscopy explode all trees #7 (#1 OR #2 OR #3 OR #4 OR #5 OR #6) #8 MeSH descriptor Cryotherapy explode all trees #9 (#7 AND #8) PEDro

Using the 'Advanced search' option, each term in the ‘Abstract & Title’ field will be combined with each term in the ‘Subdiscipline’ field in separate searches.

Abstract & Title: Cryotherapy Body part: lower leg or knee Subdiscipline: Method: clinical trial When searching: match all search terms (AND)

SPORTDISCUS #1 DE "ANTERIOR cruciate ligament" OR “Cruciate Ligament, Anterior” OR “Anterior Cruciate Ligaments” OR “Cruciate Ligaments, Anterior” OR “Ligament, Anterior Cruciate” OR “Ligaments, Anterior Cruciate” OR “Anterior Cruciate Ligament Injury” OR “Anterior Cruciate Ligament Injuries” OR “Anterior Cruciate Ligament Repair” OR “Anterior Cruciate Ligament Tears” OR “Anterior Cruciate Ligament Reconstruction” OR “Bone-Patellar Tendon-Bone Graft” OR “Bone Patellar Tendon Bone Graft” OR “Bone-Patellar Tendon-Bone Grafts” OR “Graft, Bone-Patellar Tendon-Bone” OR “Grafts, Bone-Patellar Tendon-Bone” OR “Knee” OR “Knees” OR “Knee Joint” OR “Joint, Knee” OR “Joints, Knee” OR “Knee Joints” OR “Knee Injuries” OR “Knee injuries” OR “Knee Injury” OR “Injuries, Knee” OR “Injury, Knee” OR “Knee Instability” OR “Knee Reconstruction” OR “Knee Repair” OR “Knee Damage” OR “Knee Impingement” OR “Knee Ligament Injury” OR “Acutely Injured Knee” OR “Cruciate Knee Surgery” OR “Arthroscopy” OR “Arthroscopies” OR “Arthroscopic Surgical Procedures” OR “Arthroscopic Surgical Procedure” OR “Procedure, Arthroscopic Surgical” OR “Procedures, Arthroscopic Surgical” OR “Surgical Procedure, Arthroscopic” OR “Surgery, Arthroscopic” OR “Surgical Procedures, Arthroscopic” OR “Arthroscopic Surgery” OR “Arthroscopic Surgeries” OR “Surgeries, Arthroscopic” OR “Arthroscopic Lateral Retinacular Release” OR “Knee Joint Arthroscopy” OR “Knee Joint Arthroscopies” OR “Arthroscopic Knee Surgery” OR “Arthroscopic Knee Surgeries” OR “Knee Arthroscopy” OR “Knee Arthroscopies” #2 DE “COLD (Temperature) -- Therapeutic use” OR “Cryotherapy” OR “Cryotherapies” OR “Therapy, Cold” OR “Cold Therapies” OR “Therapies, Cold” OR “Cold Therapy” OR “Ice Therapy” OR “Ice Therapies” OR “Cubed Ice” OR “Crushed Ice” OR “Ice Packs” OR “Ice Pack” OR “Cold Packs” OR “Ice Bag” OR “Ice Bags” OR “Cold Pack” OR “Cooling Pads” OR “Cooling Pad” OR “Cold Compression” OR “Cooled Water” OR “Cold Bags” OR “Cold Bag” OR “Cold

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ACCEPTED MANUSCRIPTGel Packs” OR “Ice Massage” OR “Cold Water” OR “Ice Bath” OR “Cold Gel” OR “Cold Therapy Gel” OR “Cold Application” OR “Cold Applications” OR “Cold Water Immersion” OR “Cryokinetic” OR “Cryotherapeutic Agents” OR “Local Cooling” OR “Therapeutic Cooling” OR “Continuous Cryotherapy” OR “Cryocuff” OR “Thermal Therapy” OR “Cryotherapy Device” OR “Hypothermia” OR “Thermotherapy” OR “Continuous Flow Cold Therapy” OR “Ice Pack Therapy” OR “Cold Gel Pack” OR “Cold Compressive Dressing” OR “Cold Compressive Devices” OR “Thermal Modalities” OR “Ice Treatment” OR “Chipped Ice” OR “Ice Machines” OR “Ice Submersion” OR “Wetted Ice”

CINAHL S1 (MH "Anterior Cruciate Ligament") OR S2 (MH "Anterior Cruciate Ligament Injuries") OR S3 (MH "Knee") OR (MH "Knee Joint") OR S4 (MH "Arthroscopy") S5 (S1 OR S2 OR S3 OR S4) S6 (MH "Cryotherapy") S7 (S5 AND S6) LILACS

((Anterior Cruciate Ligament) OR (Ligamento Cruzado Anterior) OR (Ex A02.513.514.100) OR (Anterior Cruciate Ligament Reconstruction) OR (Reconstrucción del Ligamento Cruzado Anterior) OR (Reconstrução do Ligamento Cruzado Anterior) OR (E02.718.050) OR (E04.555.085) OR (E04.555.110.026) OR (E04.680.051) OR (knee) OR (joelho) OR (Rodilla) OR (Ex A01.378.610.450) OR (Knee Injuries) OR (Traumatismos de la Rodilla) OR (Traumatismos do Joelho) OR (Lesões do Joelho) OR (Ex C21.866.558.554) OR (Arthroscopy) OR (Artroscopía) OR (Artroscopia) OR (E01.370.388.250.070) OR (E04.555.113) OR (E04.800.250.070)) AND ((cryotherapy) OR (crioterapia) OR (terapia a frio) OR (terapia por frio) OR (Ex E02.258)) AND ((Pt randomized controlled trial OR Pt controlled clinical trial OR Mh randomized controlled trials OR Mh random allocation OR Mh double-blind method OR Mh single-blind method) AND NOT (Ct animal AND NOT (Ct human and Ct animal)) OR (Pt clinical trial OR Ex E05.318.760.535$ OR (Tw clin$ AND (Tw trial$ OR Tw ensa$ OR Tw estud$ OR Tw experim$ OR Tw investiga$)) OR ((Tw singl$ OR Tw simple$ OR Tw doubl$ OR Tw doble$ OR Tw duplo$ OR Tw trebl$ OR Tw trip$) AND (Tw blind$ OR Tw cego$ OR Tw ciego$ OR Tw mask$ OR Tw mascar$)) OR Mh placebos OR Tw placebo$ OR (Tw random$ OR Tw randon$ OR Tw casual$ OR Tw acaso$ OR Tw azar OR Tw aleator$) OR Mh research design) AND NOT (Ct animal AND NOT (Ct human and Ct animal)) OR (Ct comparative study OR Ex E05.337$ OR Mh follow-up studies OR Mh prospective studies OR Tw control$ OR Tw prospectiv$ OR Tw volunt$ OR Tw volunteer$) AND NOT (Ct animal AND NOT (Ct human and Ct animal)))

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Acknowledgements 1

We would like to thank Dr. Alvaro Nagib Atallah and the Brazilian 2

Cochrane Centre team for methodological support. 3

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ACCEPTED MANUSCRIPTTABLE 1: Main characteristics and findings of ten studies on cryotherapy after

anterior cruciate ligament reconstruction.

STUDY DESIGN

PARTICIPANTS

INTERVENTION OUTCOMES MEASURED AND RESULTS

Cohn et al., 1989

RCT

54 patients G1 (n = 26) 17 M / 9 W mean age 22.9 y G2 (n = 28) 15 M / 13 W mean age 25.1 y

G1: CCD (10°C) (continuously up to hospital discharge) G2: Ice bags (applied once – 30 minutes)

1. Use of analgesic medication (total doses, mg/Kg) of IM meperidine, oral hydroxyzine and hydrocodone, measured 48 hours after surgery 2. Length of hospital stay 3. Adverse events G1 patients used significantly less IM meperidine and oral hydroxyzine (p < 0.01). One G2 patient had transient peroneal nerve palsy.

Schröder & Passler, 1994

RCT


G1: CCD (continuously up to hospital G2: Ice bags (three times/day)

1. Pain intensity (VAS) 2. Edema (knee circumference measured using tape) 3. Range of motion-ROM (in degrees) 4. Knee function (knee score of Noyes and McGinniss) 5. Use of analgesic medication (total doses, mg/Kg) of oral tilidine, IM pethidine and piritramide 6. Blood loss (in ml) 7. Adverse events Outcomes were measured on days: 1, 2, 3, 6, 14, 28. G1 had significant differences in: ROM on all days (p < 0.01); VAS pain scale on the 6th day (p < 0.01); knee edema on the 3rd and 6th days (p<0.035), knee function (p < 0.025) and used less oral tilidine and IM piritramide (p < 0.04). There were no adverse events.

Konrath et al., 1996

RCT

100 patients G1 (n = 27) 21M/6W mean age 27 y G2 (n = 23) 13M/10W mean age 25 y G3 (n = 23) 17M/6W mean age 26 y G4 (n = 27) 16M/11W mean age 26 y

G1: CCD with cold water (10°C) (continuously up to hospital discharge) G2: CCD water at room temperature (25°C) (continuously up to hospital discharge) G3: ice packs changed every 4 hours (up to hospital discharge) G4: no cold therapy

1. Use of analgesic medication (total doses, mg/kg) of IM meperidine and hydroxyzine; and oral hydrocodone 2. ROM (in degrees) 3. Length of hospital stay 4. Blood loss (in ml) 5. Adverse events All outcomes were measured before hospital discharge There were no significant differences between the groups. There were no adverse events.

Brandsson et al.,

1996 RCT

50 patients G1 (n = 20) G2 (n = 20) G3 (n = 10) 31 M / 19 W mean age 26 y

G1: CCD (continuously - first 24 hours) + IA injection of physiological saline. G2: CCD (continuously - first 24 hours) + IA injection of

1. Pain intensity (VAS), measured 1, 2, 4, 6, 24 and 48 hours after surgery. 2. Use of analgesic medication (total doses , mg/Kg) of codeine and morphine measured 24 and 48 hours after surgery. 3. Length of hospital stay (measured in days) 4. Patient satisfaction 5. Adverse events G1 had significantly less pain (p < 0.05) and use of analgesic medication (p < 0.05), compared with G3. In G1, 80% were

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satisfied with their pain relief, compared with 30% in G3 (p < 0.05). There were no adverse events.

Edwards et al., 1996

RCT

71 patients G1 (n = 26) 18 M / 8 W mean age 28.7 y G2 (n = 21) 17 M / 4 W mean age 26 y G3 (n = 24) 15 M / 9 W mean age 28 y

G1: CCD cold water (continuously - first 36 hours) G2: CCD water at room temperature (continuously - first 36 hours) G3: no cold therapy

1. Pain intensity (VAS) 2. Use of analgesic medication (total doses, mg/Kg) of injectable morphine, oral paracetamol and codeine 3. ROM (in degrees) 4. Blood loss (in ml) 5. Adverse events Outcomes measurement: 24 and 48 hours after surgery There were no significant differences between groups. There were no adverse events.

Dervin et al., 1998

Quasi-RCT


G1: CCD with cold water (continuously up to hospital discharge) G2: CCD with water at room temperature (continuously up to hospital discharge)

1. Pain intensity (VAS) 2. Use of analgesic medication; total doses, (mg/Kg) of morphine and number of codeine tablets (30 mg) 3. Length of hospital stay (in days) 4. Blood loss (ml) 5. Adverse events Outcomes measurement: 24 hours after surgery. There were no significant differences between the groups. There were no adverse events.

Barber et al., 1998 Quasi-RCT

100 patients G1 (n = 51) 34 M / 17 W mean age 34 y G2 (n = 49) 40 M / 9 W mean age 34 y

G1: CCD continuously G2: no cold therapy

1. Pain intensity (VAS and Likert categorical pain score) 2. Edema (knee circumference measured using tape) 3. ROM (in degrees) 4. Use of analgesic medication (total doses, mg/Kg) of oxycodone/paracetamol and hydrocodone Outcomes measurement: 1, 2, and 8 hours, and daily evaluations lasting up to 1 week after surgery. G1 had marginally significant pain reduction, 24 hours after surgery (p =0.059) and significant reduction in hydrocodone use (p =0.013). There were no adverse events.

Ohkoshi et al., 1999

Quasi-RCT

21 patients G1 (n = 7) G2 (n = 7) G3 (n = 7) 10 M / 11 W mean age 22.1 y

G1: continuous CCD (5°C) G2: continuous CCD (10°C) G3: no cold therapy

1. Pain intensity (VAS) 2. Use of analgesic medication : total doses of 25 mg of diclofenac sodium consumed, via suppository. 3. Blood loss (ml) Outcomes measurement: 48 hours after surgery G2 had significantly lower VAS pain scores and fewer number of analgesic doses than G3 (p <0.05). Blood loss was significantly lower in G1 than in G3 (p <0.01). There were no adverse events.

Dambros et al., 2012 RCT

19 patients G1 (n = 10) G2 (n = 9) 19 M / 0 W mean age 29.5 y

G1: ice packs 20 minutes, twice a day G2: no cold therapy

1. Pain intensity (VAS) 2. ROM (in degrees) Outcomes measurement: 24 hours after surgery. There were no significant differences between groups. There were no adverse events.

Waterman et al.,

36 patients

G1: CCD (3 sessions (30

1. Pain intensity (VAS) 2. Edema (knee circumference measured using tape)

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ACCEPTED

ACCEPTED MANUSCRIPT2012 RCT

G1 (n = 18) 15 M / 3 W mean age 28.7 y G2 (n = 18) 15 M / 3 W mean age 30.9 y

minutes) / day for 6 weeks) G2: Conventional ice pack therapy (3 sessions (30 minutes) / day for 6 weeks)

3. Use of analgesic medication (not reported) 4. Knee function (Lysholm score) 5. Quality of life (SF-36) Outcomes measurement: 1, 2, and 6 weeks after surgery G1 had significantly lower VAS pain scores (p < 0.0001) and discontinued use of pain medications, by 6 weeks (p = 0.0008). There were no adverse events.

CCD, Cold compression device; G1, group 1; G2, group 2; G3 group 3; G4 group 4; IM, intramuscular; IA, intra-

articular; M, men; ml, milliliters; mg/Kg, milligrams/kilograms; Quasi-RCT , quasi-randomized controlled trial; RCT,

randomized clinical trial; ROM, range of motion; VAS, visual analogue scale; W, women; y, years.

MANUSCRIP

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ACCEPTED

ACCEPTED MANUSCRIPT

effectiveness and safety of cryotherapy after arthroscopic anterior cruciate ligament...

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