Gniel Journal of Sport Medicine Sr7Sia6 © 1998 Raen Press, Lid, New York Treatment Modalities for Soft Tissue Injuries of the Ankle: A Critical Review *D. J. Ogilvie-Harris, M.8., cH.B., and M. Gilbart “Department of Orthopaedic Surgery, The University of Toronto, Toronto, Ontario, Canada Abstract: We reviewed the English language medical literature on soft tissue injuries of the ankle published between 1966 and 1993. There were 150 articles reviewed of which 84 dealt substantially with ankle soft tissue injuries. The papers were analyzed for quality and it was found that there were significant weaknesses throughout the literature. This related particularly to randomiza- tion, blinded assessment, and outcome measures. The results ofthe treatment of 32,025 patients were reported in 84 studies. We were unable to gather sufficient data from these studies to perform a statistical analysis ofthe differ- ent forms of treatment. Our conclusions were that nonsteroidal antiinflamma- tory drugs shortened the time period to recovery and were associated with less pain. Active mobilization appeared to be the treatment of choice. Studies also showed that cryotherapy was of benefit and diapulse may be helpful. There ‘was insufficient evidence to conclude that enzyme treatment, topical gels, ultrasound or diathermy, joint aspiration or injection were of benefit. Overall the literature would substantiate active mobilization following ankle sprains with judicious early use of nonsteroidal antiinflammatory drugs and the use of cryoiherapy and diapulse in the treatment of ankle injuries. Our study suggests further investigations need to be carried out into the effectiveness and out- comes following alternative forms of therapy for ankle injuries. Key Word Ankle—Soft tissue injury—NSAID—Diapulse—Cryotherapy—Physio- therapy. Clin J Sport Med 1995; 3):175-86. Ankle injuries are among the most common inju- ries seen in sports medicine and result in consider- able morbidity and financial cost. These injuries are not always trivial, and it has been estimated that 25, to 40% may be associated with recurrent instability or prolonged disability (8,32). These estimates seem higher than usually seen in clinical practice. Liga- ‘mentous injuries compose the bulk of all soft tissue injuries around the ankle. For ligament tears, Cass and Morrey (16) classified such injuries into three grades: grade 1 is a mild stretch of the ligament with no laxity, grade 2 is a moderate but incomplete tear of the ligament with minimal laxity, and grade 3 is a complete tear characterized by instability. Inflammation is usually the result of these acute ‘Received July 7, 1994, Accepted Jan. 19, 1995 Address correspondence and reprint requests to Dr. D. J, Ogilvie-Hartis at Department of Orthopaedic Sutgery, The Uni- versity of Toronto, ‘The Toronto Hospital, Room 1-032 Edith Cavell Wing, Toronto Westem Division, 399 Bathurst Street, Toronto, Ontario MST 288 Canada. 175 injuries (capsular-ligamentous) of the soft tissues around the ankle. This causes pain, edema, and red- ness as a direct result of soft tissue trauma, The histamines and bradykinins cause vasodilation and enhance permeability of the peripheral capillaries. ‘The accumulation of fluid around an injury site compounds the extent of tissue damage associated with the acute event, delays healing, and may even- tually result in some degree of chronic disability. There have been numerous modes of treatment studied for such acute soft tissue injuries of the an- Kle, but the comparative efficacy of these modes in terms of the rapidity of recovery of function and freedom from long-term ankle impairment has not been clearly defined. The main aims of these treat- ments have been to relieve pain, reduce swelling, and restore normal function and prevent clinical changes from occurring in the acute phase. Pub- lished methods of management have included cryo- therapy; early ambulation; joint aspiration and local injection of anesthetic, steroids, and hyaluronidase; oral proteolytic enzymes; NSAIDs(nonsteroidal an- tiinflammatory drugs); ultrasound; adhesive strap-; diathermy; primary suture repair; and immo- ation. The purpose of this review is to review the liter- ature on the treatment of soft tissue injuries of the ankle in order to evaluate whether any particular form of treatment provides better results, We car- ried out a metaanalysis of the literature to find proven techniques. This is an important issue not only to achieve optimal functional recovery but also in view of the cost implications of treatment. MATERIAL The Medline and Excerpta Medica databases were both reviewed from 1966 through 1993 inclu- sive to review thoroughly the English-language medical and paramedical literature published on soft tissue injuries of the ankle. In total, over 150 articles were reviewed, including 18 review articles; 17 on the mechanism, pathophysiology, and/or di- agnosis of ankle injuries; 8 letters to editors; and 118 on medical treatment or surgery. Of these 118 articles on treatment modalities, 80 were specific to soft tissue injuries of the ankle (mainly ligamentous injuries). Many articles dealing with treatment mo- dalities for soft tissue injuries in general had to be excluded either because they contained too few an- le injuries in their treatment group, or because the results for the specific ankle injury population could not be extracted from the results. Individual case reports were also not considered in the analysis. Half the cases in a study had to be ankle injuries to be included in this review. Thus, 84 articles were characterized and studied. Table '| categorizes the reviewed articles on treatment modalities of soft tis- sue injuries of the ankle according to the design employed in the study. METHOD Most of the papers reviewed were comparati studies, but 12 were noncomparative (Table 1). In this analysis, papers were categorized into one of six groups, including pharmacological treatments, D. J. OGILVIE-HARRIS AND M. GILBART surgical repair, active mobilization, cryotherapy, diathermy, and other" treatment modalities. Each paper was analyzed with respect to the 10 charac- teristics of an ideal study. On each characteristic, the study was given a Oif it did not meet the criteria, and 1 if it did. The quality score was simply a sum of these points, with a maximum therefore of 10. ‘The 10 characteristics are a revised version of Weil ers (76) list of characteristics for the prototypical ideal study of the use of NSAIDS in sport soft tissue injury. They were altered so that they might be ap- plied to all treatment modalities in this study. These characteristics are as follows: (@) Double-blind. Unless the experimenter and the subjects were blinded as to the treatment being received, unacceptable bias might result. (b) Randomize patients. Unfortunately, with many of the papers analyzed in this study, the method of randomization was not explained.’ One must question whether the randomization proce- dure was a suitable one, such as a block random- ization. This type tends to decrease the possibility that an excessive number of patients with similar characteristics will be enrolled in the same treat- ‘ment group. (©) Placebo controlled. It is essential to provide a control group because soft tissue injuries will usu- ally heal in the absence of any treatment. Failure to do so will preclude investigators from assessing the true extent of improvement with the treatmer (@) Rigorously control interval between injury and beginning of treatment. Because treatment of these injuries generally begins in the acute postin- jury stage, and because the body will begin healing itself soon after injury, the interval after injury should be similar if comparisons are going to be made with other studies. It is known that there is steady improvement beginning soon after injury. (c) Stratify severity of injuries. It is obvious that Grade 1 and Grade 3 ankle injuries will heal at en- tirely different rates, and more severe injuries may naturally be treated more intensively by the clini- cian, Patients should thus be grouped according to severity of injury if proper comparisons of treat- TABLE 1. Overview of study characteristics ‘otsl Total Pharmac. Tx Surg repair. Activermab. Cryotherapy Diathermy Other Tx's Study types studies patients we patents” patients pallens’ palienln, piety patients Noncompartive 2 or = = ome = wae) Retrospective 7 339 = = 59 =) = « Prospective 5 Ea = = Hd = wa=) Comparative TD 118168 (= 1) LTT) ABAD) aw~=9) 11s = 1) ‘Nonconelled 4 409 in = 1) “=D SED) Mia 19 =D Contrales 33s "bos = 4) i) B=) n= 3) 555 = 9) Retrospective 3 sia = ) = a M0 (n= 0. Prospective 666164 = 1) ABI = 1) LAB 13) 3H =S)SMH=T TSK = TD Prospective and ‘andomized SB 6205S LNB =) 1A 2) = HMA HEH Total number of ‘studies au ‘Pharmac Tx, pharmacological weatmeat; sug, surgical; mob, mobilization; Tx, wealment, m, aumber of studies. (lin J Sport Med, Vol 5, No.3. 1985SOFT TISSUE ANKLE INJURIES 77 ments are going to be made. Otherwise, too many severe injuries may be allocated to one treatment modality group. (f) Exclude severe injuries. It is important to sep- arate those patients who have suffered more serious injuries (such as avulsion or osteochondral frac- tures, etc.) Unless this is done, there will be too much variability in the subject groups being com- pared. Most studies did ensure that such severe in- Juries were excluded. (g) Examine the possibility that the treatment will benefit as well as harm the injured patient. Signifi- cance tests should be two-tailed to determine if the procedure or drug is causing any harm. (h) Control age, race, size, and sex. This is an important quality, for patients with widely varying characteristics may expect different functional re~ sults in some cases. () Define objective signs to be examined prior to the beginning of the experiment. It is proper to de- fine the criteria to be compared for significance be- fore the experimental results are collected. @ Define endpoints specifically. The time to re- turn to work, practice, competition, and so forth should be defined before the beginning of the study also. Interestingly, a recent publication by Easter- brook et al. (25) determined that there is a higher probability of significant experimental results being, published than results that show no statistically si nificant difference. This was particularly evident in observational studies. The report thus warned that “conclusions based upon a review of published data should be interpreted cautiously.” Thus, in our cur- rent review, although comparisons are made be- tween the number of statistically significant versus the number of insignificant studies, one must be cautious not to prepare widespread, generalizing conclusions on the basis of these results. RESULTS. Each of the 84 articles was evaluated in relation to the 10 characteristics of an ideal study and was assigned a quality score. The scores ranged from 0 to 7, with 0 indicating the weakest study possible (Fig. 1). The average score for the 84 studies was 3.9. Overall, there were 32,025 patients in the stud- ies (Table 1). The highest number of criteria met by any one experiment was seven, and five studies possessed this characteristic. Tt was found that 23 of the studies were con- ducted in a double-blind fashion; 58 of them were randomized. It is important to stress the weakness of many of these articles, which were nonrandom- ized. In fact, of those that were randomized, only a few articles briefly described the randomization process, leaving the reader to question whether a block design or some weaker method was utilized. Of the 84 studies, 30 stated that a placebo or a 25 —— n| gis} 2 g 210) : I J 0°1°2°3°4°6 "67°89 10 ‘SCORE FIG. 1. The number of studies receiving a quality score of 1 107. Tho maximum score was 7; no studies racolved 8, 9, or 10, control group was utilized, 41 rigorously controlled the interval between injury and the beginning of treatment , and six stratified the severity of injuries. ‘The small number in this latter group illustrates the fact that in many experiments injuries of varying severities were grouped together, such as grade 1 and grade 2 ankle sprains. This is not always an oversight by the investigator, however; in some cases it is difficult to distinguish the difference clin- ically between slightly differing types of sprains. In 54 studies, however, the very severe injuries were excluded. In seven studies, the possibility that the treat- ment (generally pharmacological) would harm the patient was assessed. In addition, eight studies con- trolled for age, race, size, and sex. The objective signs to be examined were defined in 71 cases prior to the beginning of the study—this criteria was the most often fulfilled by investigators. Finally, 10 of the studies defined their endpoints specifically. Our analyses of the 84 articles were grouped ac- cording to treatment modality deemed to be of pri- mary importance in the study (Tables 1~7). For ex- ample, a study comparing two NSAIDs to placebo in which one drug was found to be significantly bet- ter than another was categorized under the better drug only. In each case, treatment modalities were analyzed in terms of the number of statistically sig- nificant and insignificant study conclusions pre- sented. Of the studies analyzed, however, only a few possessed the main qualities of studies that are most useful: prospective, double-blind, random- ized, and placebo controlled. These qualities were most common in the studies on pharmacological modalities of treatment, rather than other modal ties, This is because it is relatively easy with med- ications to provide double-blind study conditions with the use of a placebo medication, For studies comparing mobilization versus plaster casts, or cryotherapy versus contrast baths, itis virtually im- possible to fulfill all four of these important crit especially double-blind and placebo control attrib- (lin J Sport Med, Vo. 5, No.3, 19578 D. J. OGILVIE-HARRIS AND M. GILBART TABLE 2. Comparative studies on pharmacological modalities of treatment ‘Quality Sample criteria Seorel, Ref. no. authors, year i ethod of treatment Resultsleoneusions spplcasies “0 Prospective randomized Difuisl Adams, 1978 31 iflnisal v,onyphenbutazone Dilanisal signif better 12469 5 releving pain 2, Aehababian, 1986 40 —Difunsl vs acetaminophen No sii iference 2679 4 ‘with codeine 17, Bernet and Pris, 1979 Millia vs oxyphenbutazone Dif signif @ < 0.05) 249 4 “improved pan, tenderness and ROM Tuprofen SP Andersson etal, 1983 91 buproten vs placebo No signif diference 2469 5 BB, Freer ct al 1989 & Ibuprofen vs placebo No sig aierence i 6 ‘8, MeLathie eta, 1985 144 Touprofen (00 mg 4% or 1.200 Signf(p < 0.0) improvement ; tg 2% daly) vs placebo Te progress with high dose ibuprofen (6, Stoan eta, 1989 122 Touprofen immediate vs.3 days Sighlf( <0.01) improvement 1-46.79 1 ostinary ‘ith eal adm, of Ibuprofen Diclofenac “4, Bahamonde and Saavedra, 190 92 Diclofenac potassium vs. Diclofonae signif more 1469 5 pironcam vs. placebo effective reducing pain than ther two 54, Moran, 1990 108 —_Dieltemnepotasium vs. Signifinprovement of pain, 24.69 1 iconcam vs. placebo {atammtion with elotenae Proteolytic enzymes 10, Brakenbury and Kotowsk, 1960 252 Oral protealytc enzymes Signi faster rate of resolution 1-469 ‘ (Chymora) vs. placebo ‘wth Chyroral 13, Candee etal 991, 9 oat Sigil decrease sympioms in 1-369 5 treptokiase-steptodoraase patents receiving SS we placebo. Eonbisation 20, Crag, 1975, 50 Chymoral vs lactose tablets No sig difference 5 (acebo) Gestreams "21, Diebiehag etal, 1990 37 Ketorolac vs, eofenamate gel Sig eduction in ankle pain ‘ ‘vs placebo nd sweling wth Ketorolac 22, Dreier et al, 1990 6 Nilumic acid gel vs placebo _Sigif reduction in pain, 5 ci ‘verl elective with ‘iumis aid 26, Elswood and MacLeod, 1985 52 Benzydamine and Turbgrp vs. No sigif diference 139 4 “Tobi vs. Turbieip snd plucebo 45, Linde et al, 1986, 2 Benzydamine and bandage vs. __Signif' eduction in swelling 1-469 6 bandage and placebo vs. no with benzydamine treaiment Others Fuurbiprote 28, Finch ef 0 Sisif © < 0.09 decrease 1246196 pain with Nurbiprofen Ctonixin 75, Vika and Rokkanen, 1983 119 Clonixinvs.oxyphenbutazose _Clonixn sign etter than 1469, 1 ‘Ws placebo ‘lcebo estimated beter {han oxyptenbutazone Prospetive nonrandomized Tupofen 4, Dupont ot al, 1987 61___toaprofen vs. placebo [No signif ference 13469 s ‘Signi, slgiicant; physio, physiotherapy; ROM, range of motion; dit, ference. * Criteria applicable show which entra (10) were flled by the pape. utes. In such studies that are not double-blinded, the observer may in fact be blinded to the patient's treatment. Thus, although these studies may have fulfilled less criteria, it should be recognized that in many cases the cause was the particular types of modalities compared, not poor study designs. PHARMACOLOGICAL AGENTS. For the pharmacological treatment modalities (Table 2), 19 studies were reviewed. Of these, 18 (lin. J Sport Med, Vol 5, No.3, 1995 ‘were prospective randomized and one was nonran- domized. Eleven of the 18 prospective randomized studies also fulfilled the double-blind, placebo- controlled criteria of the most useful studies. Of the four studies published on diflunisal, two were com- parative studies of diflunisal versus oxyphenbuta- zone (I-3,28). Both studies indicated a significant improvement in pain relief with diflunisal, and Ber- nett et al. also found a significant improvement in tenderness and range of motion with diflunisal (7). OF the remaining two studies, Aghababian showedSOFT TISSUE ANKLE INJURIES 179 TABLE 3. Studies on surgical repair or active mobilization Quality Sample Chitera “Scare! Ref, no, authors, year Method of treatment Resultsconcusions applicable “0 Surpea eps Prospective randomized 12, Brostrom L, 1966 a ‘Shorter recovery period with 2 repair and east, rmobiaton 27, Evans et al, 1984 co Surgical repair and cast vs. No signi ference 4 ea 31, Freeman MAR, 1965 45 Strapping vs. cast vs. surpical Shorter period of disability, 2 repair and east, ‘nd more patient free of symptoms with mobilization 30, Freeman MAR, 1965 42 Strapping and mobilization No sig dif in stably 1yr" 2.69 3 ‘sr east vs operative repair > pstnury nd immobilization 33, Gronmark et al, 1983 85 Strapping and physio vs ast Surpical repair best longserm 2,69 3 ‘ws surplcal eparand cast. reslls tapping best 41, Korkla etal, 1987 150 Tesoplast bandage vs. cast (4 No sig fat follow-up, 26.79 ‘ ‘weeks) vs, surgical repair bat bandage group less tnd cost Stabty 53, Moller Larsen etal, 1988 175 Strapping (pe) vs. cast vs. ‘Sigil € 0.8) more ps. 259 3 Supial rept and east retire to preinjury sa symptomatic wit tape 6, Niedermann ea, 1981 209 Sugisal repair vs, phster cast No signi difin subjective or 2.49 3 ‘objective findings afer 1 Ye 70, Sommer and Arza, 1989 8 Elastic bandage vs. surgical «No signi ell’ 269 3 pair and east, 74, van den Hoogenbund ctl 1984 150 —Coumans bandage vs. cas vs. Signi faster recovery with 249.10 4 ‘surglea! repair and east Sandages no sig tin Tonge ress 1%, Zipp etal, 1991 200 Ely fuptionl treatment vs. Sia beter ROM in 29,10 3 ast. Surgical repair vs conservative group conservative treatment Including subjective Stability with repair 1, Zipp and Sehiovink, 1952 200 —_Enly fupetional weatment vs. Sigaif reduction in esovery 24,69 4 can Sua repair fine in conservative group Prospective nonrandomized "8; Pace etal 1990 31 Conservative eatment vs. No signi di, bur shorter 59.10 3 ‘ule! repair eeovery time for conservative retment 6, Rike eta 1988 30 Bhasticbandoge vs, surgical Surgical treatment better 9 1 repair “unetinal recovery, not, signiiant though 66, Ruth C3, 1961 ot Surgicel repair and east vs. Concluded surgical results ° ' cn ‘beter; long-term reals not signi Retrospective 1, Clark eal, 1965 24 Surgical repair vs. cast, [No signif ference 69 2 ‘iobiliation 73, Vahvanen et a, 1983 90 Elastic bandage vs. cast vs. Fewer longterm symptoms in ° ‘sical repair ‘operative group ‘Astive mobilization Prospective randomized ‘Sy Andersson etal, 1983 91 Ace bandage vs. Daver (high No sign diterence 23469 5 ‘ual tandage 10, Brakenbury and Kotowsk, xx 252 Cast vsclasic Turbirip)—_—Signif decrease edema, 1469 6 ‘bandage recovery time with ‘Turis 1, Brooks ea, 1981 102 Turbigsp ws. physiotherapy Early mobility, with or 2.69.10 4 "sina bandage vs. ‘without physio fers best ait results 40, Konradsen eta, 1991 73 Mobily instabiizing onhosis—Signif(@ <0.05)improved «2.46910 vs cas immoblizsion| a, maby and foneion ‘ith onesie 55, Muwangn et a, 1986 144 Double Turbigrp vs. everson Notingham signi’ < 002) 2,469 4 ‘strapping vs. Netingham tore patie! confidence ankle suppor 57, O'Hara et al, 192 220 Mallon support vs 2369 4 imple support 4, Royeroft and Manian 1983, 80° Early active management and 26 2 ysl vs. conservative recovery In early physio Treatment and later physio treatment group 65, Rucinsl et al, 1991 30 etalewap vs trmitent Elatedconrel gp gst 2.4.69, s nematic compression vs. lowest amount of edema onal elevation) (lin Sport Med, Vo. $, No.3, 1995180 D. J. OGILVIE-HARRIS AND M. GILBART TABLE 3—(Continued) ‘Quality itera “Score Ref, no. authors, year Method of treatment Resulsconeusions sppicalet “10 15, Cae ah, 1964 lone sapring ve. cast @ Sigal faster recovery in 269 3 ‘weeks va, injestion of Strapping vs ist groups Fydrocotione 32, Freeman MAR etal 1965 84 Physio and coordinated Signi better stability and 29 2 ‘tuning vs. physio WS. cast coordination in physio and inmobifston coordinated trained group 17, Scots and Gut, 1992 184 Strapping (ape) vs. geleast ——Sigair(p = 001 beter 246 3 "sd tapping tape), Tealing rat wih daily for 3 anys sappng ‘THe Wilkerson and Horn-Kingsry, 34—‘Uniform compression (ape) No signif dif, although focal 2.4.69 4 1 ‘s. focal compression with compression appears fxyotherapy vs focal comp. benef, Prospective nonrandomized "tr Lind ot al, 1988 10 Compression bandage vs. no No sign aiforence 6 2 ‘Signi, significant; physio, physiotherapy; ROM, range of mation: i, difeence. "Geis epplleable shows which ere (1-10) were fulfilled by the pape. no significant difference in resultant pain, swelling, and limitation of motion as compared to acetamin- ‘ophen with codeine (2). Finch et al. concluded that flurbiprofen provided significantly greater pain re- lief than diflunisal (28). In a study comparing the efficacy of clonixin, oxyphenbutazone and placebo, Viljakka and Rokkanen showed significantly better recovery results with clonixin over placebo, and es- timated better results with clonixin over oxyphen- butazone (75). Work by Bahamonde and Saavedra (4) and Moran comparing diclofenac with piroxicam and placebo found significantly better results in the diclofenac group (54). Five studies were published concerning the use of ibuprofen (2,24,29,49,65). In 3 of these studies (one of which was nonrandomized) no significant differ- ence was found between ibuprofen and placebo. McLatchie et al. showed that high does ibuprofen provided a significantly better improvement in progress over placebo (49), Sloan et al. also showed that ibuprofen administration immediately postin- jury provided a significant improvement over pla- ccebo (69). ‘Three studies were performed that compared pro- teolytic enzymes and placebo controls (10,13,20). Calandre et al. found a significantly faster rate of symptom relief in the streptokinase-streptodornase group over placebo (13). In two separate expel ments comparing Chymoral (oral proteolytic en- zyme) administration to placebo, Brakenbury and Kotowski found a significantly faster rate of reso- lution in the placebo group (10), although Craig TABLE 4. Comparative studies on cryotherapy Quality Sample Criteria Score! Ref, no., authors, year size Method of treatment Resultslconclusion applicable 10 Prospective randomized 19, Cote etal, 1988 30 Cold vs. heat vs. contrast Sign (p < 0.09) less 269 3 ‘bath edema with cooling 3-5 ny ©, Sloan, Hain, Pownall, 1989 143 Cryotherapy vs. placebo swelling, 4,69 6 (Gimulated) therapy, for ROM, or ability to 45min ‘weight bear 42, Laba, 1989 30 Tee treatment (20 min) and No signif dif in pain, 246910 5 physio. vs. no ice and sweling, or speed of physiotherapy recovery in Wo groups Prospective nonrandomized 6, Basur etal, 1976 60 Cooling and crepe Cooling reduced pain, 35 2 ‘bandaging vs. erepe ‘edema, and shortened bandaging recovery period 37, Hocutt etal, 1982 37 Cryotherapy vs. heat Cryotherapy within 36h 4,5 2 therapy ppostnjury, Sigit (@ < 0.05) improved recovery time ‘Signi, significant; physio, physiotherapy; ROM, range of motion; dif, difference. * Criteria applicable shows which criteria (1-10) were fulfilled by the paper. (Clin. J Sport Med, Vol. 8, No.3, 1995SOFT TISSUE ANKLE INJURIES 181 ‘TABLE 5. Comparative studies on diathermy Quality Sample Criteria Score! Ref, no, authors, year Method of treatment Resultslconclusions applicable" 10 Prospective randomized 5, Barker etal, 1985 73 Low power shortwave No signif diterence 149 5 therapy vs. placebo 51, Michlovitz etal, 1988 30 Highvoltage pulsed No signif diff in pain, 2-469 5 stimulation and ICE vs. edema, or ROM ICE alone 60, Pasiia et al., 1978 300 Diapuise vs. Curapuls vs. Signi better results with 1 placebo Diapulse and Curapuls lacebo 1, Pennington etal, 1993 S0._——_—Diapulse vs, placebo Signif (p< 0.01) reduced 1-469 6 ‘edema following Diapulse vs. placebo 48, McGill SN, 1988 37 Pulsed shortwave therapy No signif difference 1-469 6 vs. placebo Prospective nonrandomized 73, Wilson DH, 1974 40 Short wave diathermy vs. Sign better relief of 49 2 pulsed EM. ‘welling, pain, and sisablity with EM 80, Wilson DH, 1972 49 —_Diapulse vs. placebo if improvement in ‘ isability, pain with Diapulse vs. placebo Signi, signifieant; ICE, ice, compression, elevation; physio, physiotherapy; ROM, range of motion; diff, difference; EM, electro: magnetic energy. “Criteria applicable shows which criteria (I-10) were fulfilled by the paper. found no significant difference between the two treatments (20). Three studies compared the efficacy of various topical creams and gels to placebo postinjury. Dieb- schlag et al. showed that ketorolac gel provided a significant reduction in posttraumatic ankle pain and swelling over both etofenamate gel and placebo 0). Dreiser et al. also showed a significant reduc~ tion in pain could be achieved using niflumic acid gel versus placebo (22). Neither treatment produced any improvement in recovery time or long-term res- olution of symptoms, however. Finally, Elswood and MacLeod found no significant improvement us- ing benzydamine cream versus placebo (26). SURGICAL REPAIR, CAST, ACTIVE MOBILIZATION The modalities of surgical repair, plaster ca and active mobilization were grouped together (Ta- ble 3) because of extensive overlap between these three topics in the literature. In many cases, all three treatments were compared. Thirteen studies were performed that compared surgical repair to nonsurgical (conservative) treatment modalities. In four of these studies, conservative treatment gave significantly better results with respect to decreases in recovery time. OF the remaining nine studies that showed no significant differences, three found shorter recovery periods in the conservative ‘groups, and three studies found better long-term re- sults and stability with surgical repair. For example, Evans et al. showed that although the differences were not significant, the resumption of work activ ity was earlier by 1 to 2 weeks for patients treated conservatively versus surgically, and the residual symptoms were minimal and functional limitation rare (27). In total, there were 14 studies comparing, active mobilization and plaster cast immobilizatior In eight of these, active mobilization was signi cantly better; in four it was better but the difference did not reach significance; and in two studies, there was no difference. Finally, there were 10 st that compared different modes of active mobiliza- tion, including different bandages, ankle supports, and physiotherapy. Two studies stated that better results were achieved with early physiotherapy. Three studies compared different supportive de- vices, and showed significantly better results for the three ‘different supports (Nottingham, Malleotrain, and daily strapping). Four studies showed no si nificant differences in the bandages compared; one interesting study concluded that there was a signif- icantly better result in the elevated control group than the group receiving intermittent pneumatic compression (IPC) or elastic wrap. PHYSICAL MODALITIES Five studies on cryotherapy were also reviewed (Table 4) and included three prospective random- ized and two prospective nonrandomized. In two separate studies, cryotherapy was found to be a sig- nificantly better treatment than heat. One study comparing one application of ice therapy for 45 min <24 h postinjury showed a trend in favor of the cryotherapy group, although it did not reach signif- icance. One study showed no significant difference (lin J Sport Med, Vol 8, No.3, 1995182 D. J. OGILVIE-HARRIS AND M. GILBART TABLE 6. Comparative studies on other modalities Quality Sample Cetera scare! Ref. no. authors, year se Method of treatment Resultsconctsions spplicabier “10 Prospective randomized Intermittent pacumatie compression (PC) 165, Russi et a, 1991 tasti wrap vs. IPC vs. Blevated contol group signif 2-45,8 s ‘conta elevation) Towest amount of edeme Aspiration injection 15, Caro et al, 1964 174 Blase strapping vs cast @ Signi faster recov 269 3 ‘weeks ve, injection of Tydrocortsone vs. hydrocortisone ‘rapping vs. east groups 46, MacCartes CC, 1977 100 Joint aspiration and injection No signi diference with Fey 3 ‘of lidocaine and ‘sept and injection hyaluronidase pus physio ¥s physio 81, Zotan 3D, 197 © Joint aspiration and injection Signi p< 0.000 better 2469.10 6 ‘ot Xoeaine vs. control "ecovery time in aspiration soup ‘Utrasound 47, Makulolowe and Mouzas, 1977 0 Utrasound vs. elstoplast ‘Unrasound decrease pan, 269 3 ndage ‘selling and Toss of {unetion Better than bandage 52, Middlemast and Chateree, 978 T1_—_—Uhtrasound vs, wax bath, Signi batter response with 29 3 Infrared, and shor. ‘ltrasound (he more diathermy Chermotherapy) —_symptomeee) 78, Wiliason et al, 1985 154 rasound treatment v5. difference 1210 3 contol Acupanetore 58, Pars ota, 1963, 16 Neuroprobe and physio vs. Signi nerease ROM with 2469 4 hysio meuroprobe, less pain Prospective, nonrandomized ‘Asprtioninjction 9 Brady and Arnold, 1972 47 Active mobilization vs ‘Shorter recovery time in 69 2 ‘aspiration aed injection of aspiration sroUp, not ei Tdocaine 71, Starkey JA, 1976 1 BPCand ICE Gee, Enimated 2 days recovery ° ‘compression, elevation) vs, time gained with IPC ieBony therapy, not signi Retrospective ‘Aspiration-injction 30, Mebtaster PE, 1983, 400 Strapping ape vs, ijetion Injection gave uniformly 69 2 of procaine hydrochloride beter results ‘Slaif sgnifean: physio, physioher * Criteria applicable shows which entra (I-10) were fullled by the paper. between cryotherapy and a control. Studies have recently shown that cryotherapy acts by reducing blood flow, the inflammatory response, edema pro- duction, hemorrhage, and pain sensitivity. One area for difference in these experiments is the defined acute period postinjury, which varied among exper- iments. Hocutt et al. in fact showed that cryother- apy initiated on the day of injury (day 0) or day 1 provided better resumption of full activities than cryotherapy begun on day 2 (7). Five prospective studies (Table 5) compared dia- thermy to placebo for the treatment of the acutely sprained ankle. Three of these studies concluded that there is a significantly shorter recovery period, with less pain and edema in the diathermy group. ‘Two of the studies concluded that there was no sig- nificant difference between diathermy and placebo. One study compared pulsed electromagnetic (EM) energy to short wave diathermy, and found pulsed EM therapy to be a significantly better treatment. One study compared high voltage pulsed stimula- tion and ice, compression, elevation (ICE) to ICE (lin J Sport Med, Vol. 5, No. 3,198 (OM, range of motion; i, dference. alone, and found no significant difference. The pro- posed rationale for diathermy treatment is to reduce the inflammatory response, edema, and pain. It has been well documented and is an accepted treatment form for pain control, but the mechanisms of action of electrical stimulation on edema reduction are un- known. Its action has been postulated to be related to either a muscle-pumping action or an electropho- retic effect. Table 6 outlines the studies comparing other treatment modalities, Intermittent pneumatic com- pression has been shown in two separate experi- ‘ments to make no significant difference in recovery, but Starkey estimated there was an increased re- covery time of 2 days associated with the treatment (71). There were five studies focused on aspiration- injection treatments, and in two experiments of as- piration of the subtalar joint and injection of local anesthetic, a shorter recovery time was reported (only one reached significance). In one study, the injection of hydrocortisone provided a significantly {faster recovery; in another study, the injection ofSOFT TISSUE ANKLE INJURIES 183 TABLE 7. Noncomparative studies Quality Sample Criteria Score! Ref, no., authors, year size Method of treatment Resultslconclusions applicable” 10 ‘Active mobilization Prospective 14, Came P, 1989 50 Sarmiento brace Allows mobilization and 9 1 early resumption of, daily activites 17, CettiR, 1982 51 Non-weight bearing (3 —_—Provides quick return to 469 3 ‘weeks) with sport, but 16% had exercises residual symptoms 36, Henning and Egge, 1977 8 Cast brace Comparable to full 9 1 immobilization studies in limiting early disability 45, Linde etal, 1986 150. Early mobilization Normal walking 90% after 6.9 2 (motion exercise) 1 mo residual symptoms in 1896 at lyr Retrospective 35, Hansen et al., 1979 130 Walking east (6 weeks) At follow-up, 219% of 59 2 patients had pain, swelling, or functional instability 39, Jackson and Hutson, 1986 42st brace Enables early return to ° ‘activities >3 weeks 43, Lane SE, 1990 26 Anklefoot orthosis High patient saisation; 469 3 lack of ehronic, ‘debilitating symptoms ‘72, Stover CN, 1979 7 Semitigia orthoplast Allows mobility for ° support participation in sport, ‘good functional treatment 38, Hay etal, 1982 90 Conservative treatment: Full working eapacity 1 469 3 rest, ie, and strapping mo (8996); functional instability 1 yr @1%) Cast immobilization Retrospective 23, Drez etal, 1982 39 Walking cast Success rate 79.5%, with 45,10 3 respect to roenigenograms 34, Gross and Macintosh, 1973. 25.——Plaster cast Nocomplaints 72%, pain 9 1 8%, swelling 8%, functional instability 12% Other Prospective 62, Quillen and Rouillicr, 1982 19 Rapid pneumatic Focused on efficacy; 69 2 ‘compression and cold ‘concluded it's safe and effective ‘Signi, significant; physio, physiotherapy; ROM, range of motion; dif, difference, * Criteria applicable shows which criteria (I-10) were fulfilled by the paper. hyaluronidase showed no significant difference in recovery. Three studies were performed using ultrasound treatments, and in only one of these was there a significantly better response. This response was not ‘compared to a control group, however, but instead to a thermotherapy group. One study utilizing acu- puncture revealed a significant improvement in range of movement and pain with treatment. Finally, Table 7 outlines the noncomparative studies reviewed. In nine of these studies, active mobilization was studied, and eight of these showed good general results in terms of an earlier return to activities. In two separate experiments, cast immo- bilization was studied, with a 70 to 80% success rate on average in the two experiments. The experi- menter concluded that results were satisfactory with cast immobilization. There were some interesting observations about the frequency of which criteria were fulfilled (Table 8). Criteria 5 (age, sex, race controls) were only found in two papers. Six papers examined if the ‘treatments were harmful (criteria 7). Only seven pa- pers stratified for the severity of injury (criteria 5), (Cin J Sport Med, Vol. 5, No, 3,195184 D. J. OGILVIE-HARRIS AND M. GILBART TABLE 8. Number and percentage of studies fulfiling ‘each criteria Criteria Number Percentage 1 2 0 2 56 0 3 Fa 36 4 a 9 3 7 8 6 3 6 1 6 7 8 2 2 9 66 n 10 n B Eighty-four studies in all and 11 had specific end points (criteria 10). In con- structing a study, none of these criteria are partic- ularly difficult to apply. DISCUSSION Initially we set out to gather data from the liter- ature and to perform a metaanalysis of the informa- tion. We had hoped to show whether any particular treatment was superior to a placebo or to other treatments based on the statistical analysis of the results contained in these papers. However, a re- view of the literature indicated that the information we would use to determine outcome was generally not available. There was no standardized method of scoring the severity of ankle injuries or of the re- sults of treatment of these injuries. Criteria such as, number of days of return to sport are extremely subjective and do not provide definite end points for these studies. Hence, we are unable to perform a statistical analysis despite the fact that there were 32,000 patients entered into the studies. In many studies of pharmacological treatment ‘modalities with nonsteroidal antiinflammatory med- ication, no significant difference was found between medications, but significant improvement was of- fered with these medications over placebo. In fact, good results were obtained with the use of both diflunisal and diclofenac. No particular drug was shown to be superior to others overall, however. ‘These studies provided reasonable evidence that patient recovery is faster and with less pain when treated with nonsteroidal antiinflammatories. Though recovery time was shortened with such treatment, there appeared to be no significant dif- ference in the ultimate outcome. Based on this ev- idence, the use of nonsteroidal antiinflammatory drugs for acute ankle sprains can be justified if rapid recovery and symptomatic relief is essential. Conflicting results were obtained in the three studies analyzing the efficacy of proteolytic enzyme treatment. There was no good evidence that proteo- lytic enzymes produced better overall results than placebo, and as a result they are not recommended for treatment. The use of topical gels was shown to provide some temporary relief of acute symptoms, (lin Sport Med, Vol. 3, No.3, 195 but provided no significant improvement in the final treatment outcome. ‘The majority of studies comparing surgical re~ pair, plastering, casting, and active mobilization clearly favored active mobilization as the treatment of choice. Nonsurgical treatment seemed to provide more rapid recovery than surgical repair. Stu generally failed to show that surgical repair of in- Jured ligaments provided any significant long-term improvements in symptoms such as instability and pain, Based on this information, one would not rec- ‘ommend surgical intervention. There may be a role for surgical reconstruction in severe ligamentous disruption, but this requires careful individual eval- uation and judgment. There was also conclusive ev- idence that plaster cast immobilization did not help. Active mobilization is the treatment of choice; 12 of 14 studies showed it provided better recovery. Of interest, however, is that in the long-term, all con- servative treatments seemed to produce satisfac tory results. Studies on the use of cryotherapy showed that treatment generally reduced pain, edema, and shortened the recovery period, although not all studies produced a significantly better result with cryotherapy. It had to be applied within the first day or two of injury to be effective. This treatment should remain part of the standard regime. Two studies showed diapulse significantly re- duced pain, edema, and disability following acute ankle sprains if applied relatively early in the treat- ment process. Other diathermy treatment modali- ties showed no significant improvements over pla- cebo treatments. Ultrasound was not shown to be particularly effective. Diapulse therefore may have a role in early rehabilitation. Although joint aspiration, injection of steroids and hyaluronidase, all proteolytic enzymes, ultra- sound, and intermittent pneumatic compression have all been tried, there is insufficient evidence the literature to support their use in either providing, more rapid resolution of the injury or in improving the overall outcome. CONCLUSION Our aim was to analyze the current literature and attempt to make specific recommendations about the best treatment for ankle sprains. Early mobili- zation aided by the use of bandages or strapping seems to provide the best results, by providing a faster recovery rate. The use of nonsteroidal anti- inflammatory drugs early on in the injury and for short periods of time is of value in achieving an earlier recovery, although it does not change the overall outcome. Similarly, cryotherapy helps re- duce the length of recovery although it does not change the final outcome. Diapulse diathermy seemed to offer improvement in recovery time and in relief of symptoms. Surgery was not shown to provide significant improvement.SOFT TISSUE ANKLE INJURIES "185 Our overall conclusion from reviewing the litera- ture is that ankle injuries have a good prognosis. Looking at the placebo groups in the studies, very satisfactory results are obtained with little treat- ‘ment, In most cases, long-term prognosis was not altered by treatment; but rather, acute symptoms, pain, and disability could be reduced by early treat- ment. This has a significant impact in designing fu- ture studies. It means that large numbers of patients would be necessary in the study to demonstrate sig~ nificance. One of the problems associated with many of the studies in this review is that relatively small numbers of patients were entered, and so sig~ nificant effects may have been missed. ‘There was a paucity of articles on the different modalities of muscle and ligament rehabilitation. For example, there were no articles comparing iso- metric, isotonic, or isokinetic rehabilitation for an- kle injuries. There were no articles demonstrating whether physiotherapy had any particular advat tage in the recovery from these injuries. These will be important issues to look at in the future. Many treatments, therefore, for ankle injuries are cur- rently carried out for which there is no good scien- tific evidence of effectiveness or justification of cost. Ankle sprains are a common injury, and over- all the prognosis is good. 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