[ ] research report SEBASTIÁN TRUYOLS-DOMÍNGUEZ, PT, PhD1 • JAIME SALOM-MORENO, PT2 • JAVIER ABIAN-VICEN, PT, PhD1 JOSHUA A. CLELAND, PT, PhD3-5 • CÉSAR FERNÁNDEZ-DE-LAS-PEÑAS, PT, PhD2 Efficacy of Thrust and Nonthrust Manipulation and Exercise With or Without the Addition of Myofascial Therapy for the Management of Acute Inversion Ankle Sprain: A Randomized Clinical Trial TTSTUDY DESIGN: Randomized clinical trial. TTOBJECTIVE: To compare the effects of thrust and nonthrust manipulation and exercises with and without the addition of myofascial therapy for the treatment of acute inversion ankle sprain. TTBACKGROUND: Studies have reported that thrust and nonthrust manipulations of the ankle joint are effective for the management of patients post–ankle sprain. However, it is not known whether the inclusion of soft tissue myofascial therapy could further improve clinical and functional outcomes. TTMETHODS: Fifty patients (37 men and 13 wom- en; mean SD age, 33 10 years) post–acute inversion ankle sprain were randomly assigned to 2 groups: a comparison group that received a thrust and nonthrust manipulation and exercise intervention, and an experimental group that received the same protocol and myofascial therapy. The primary outcomes were ankle pain at rest and functional ability. Additionally, ankle mobility and pressure pain threshold over the ankle were assessed by a clinician who was blinded to the treatment allocation. Outcomes of interest were captured at baseline, immediately after the treatment period, and at a 1-month follow-up. The primary analysis was the group-by-time interaction. TTRESULTS: The 2-by-3 mixed-model analyses of variance revealed a significant group-by-time interaction for ankle pain (P<.001) and functional score (P = .002), with the patients who received the combination of nonthrust and thrust manipulation and myofascial intervention experiencing a greater improvement in pain and function than those who received the nonthrust and thrust manipulation intervention alone. Significant group-by-time interactions were also observed for ankle mobility (P<.001) and pressure pain thresholds (all, P<.01), with those in the experimental group experiencing greater increases in ankle mobility and pressure pain thresholds. Between-group effect sizes were large (d>0.85) for all outcomes. L TTCONCLUSION: This study provides evidence that, in the treatment of individuals post–inversion ankle sprain, the addition of myofascial therapy to a plan of care consisting of thrust and nonthrust manipulation and exercise may further improve outcomes compared to a plan of care solely consisting of thrust and nonthrust manipulation and exercise. However, though statistically significant, the difference in improvement in the primary outcome between groups was not greater than what would be considered a minimal clinically important difference. Future studies should examine the long-term effects of these interventions in this population. TTLEVEL OF EVIDENCE: Therapy, level 1b–. J Orthop Sports Phys Ther 2013;43(5):300-309. Epub 13 March 2013. doi:10.2519/jospt.2013.4467 TTKEY WORDS: manual therapy, pressure pain threshold, triceps surae ateral ankle sprains account for 85% of all ankle sprains, are common in individuals who participate in athletic activities, and result in substantial societal burden.13,23 These injuries frequently occur when a person lands on a plantar-flexed and inverted foot.17 Typical symptoms of lateral ankle sprain include swelling, pain on palpation, and functional impairment.18 Despite the assumption of good prognosis, many individuals continue to report pain and disability 1 month after lateral ankle sprain.1 Though conservative management is the initial treatment option for these patients, the most appropriate treatment strategies to prevent chronicity have yet to be established.15 Among ankle sprains, grades 1 and 2 are more likely to recur.21 Current evidence indicates that manual therapy interventions, such as joint mobilization and manipulation, and exercises are often used by physical therapists to manage patients who have sustained an ankle sprain.2,29,30 The authors of sev- Department of Physical Therapy, Universidad Camilo José Cela, Madrid, Spain. 2Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain. 3Department of Physical Therapy, Franklin Pierce University, Concord, NH. 4Rehabilitation Services, Concord Hospital, Concord, NH. 5Manual Therapy Fellowship Program, Regis University, Denver, CO. The study protocol was approved by the Institutional Review Board of the Universidad Rey Juan Carlos. The authors certify that they have no affiliations with or financial involvement in any organization or entity with a direct financial interest in the subject matter or materials discussed in the manuscript. Address correspondence to Dr César Fernández-de-las-Peñas, Facultad de Ciencias de la Salud, Universidad Rey Juan Carlos, Avenida de Atenas s/n 28922 Alcorcón, Madrid, Spain. E-mail: cesarfdlp@yahoo.es t Copyright ©2013 Journal of Orthopaedic & Sports Physical Therapy ® 1 300 | may 2013 | volume 43 | number 5 | journal of orthopaedic & sports physical therapy 43-05 Truyols-Dominguez.indd 300 4/17/2013 3:50:47 PM eral studies have shown that manual interventions directed at the ankle-foot region result in improved mobility of the ankle8,9,16,36 and weight bearing through the foot.20 Additionally, 2 randomized clinical trials have demonstrated that, in patients post–lateral ankle sprain, manual therapy directed at the ankle is superior to a placebo or rest, ice, and compression, along with nonsteroidal anti-inflammatory drugs, for improving range of motion, pain, and function.11,24 However, the authors of a relatively recent systematic review34 concluded that, though manual mobilization has an initial positive effect on ankle dorsiflexion range of motion, the clinical relevance may be limited (level 2 evidence). Whitman et al,38 using a cohort study design, developed a clinical prediction rule to help identify individuals with subacute inversion ankle sprain who would be likely to benefit from manual therapy interventions and a general exercise protocol targeted to the ankle/foot. In this study, 75% of all patients exhibited a successful outcome.38 Hence, it is possible that the majority of individuals with lateral ankle sprain may benefit from such a treatment approach. However, a causeand-effect relationship, in the absence of a comparison group, cannot be directly inferred from this cohort study. Despite all the aforementioned studies that included manual therapy interventions, none incorporated myofascial techniques. An example of the potential effectiveness of adding myofascial techniques to a manual therapy approach was demonstrated in a randomized controlled trial on patients with plantar fasciosis.28 In that study, the patients who received myofascial therapy in addition to a best-evidence treatment approach experienced greater improvements in function and pain compared to those who were treated with a best-evidence treatment approach alone.20 The contribution of soft tissues to the etiology of chronic painful conditions like plantar fasciosis is based on alterations in soft tissue function over time. However, the need to ad- dress muscle tissues in individuals with acute conditions is still speculative. One can speculate that post–ankle sprain, the musculature surrounding the ankle (eg, gastrocnemius, tibialis anterior, fibularis) may attempt to protect the ligaments from further trauma by creating a protective soft tissue response.27 Acute injuries have been proposed as a potential mechanism of activation of myofascial trigger points (TrPs).31 As yet, no studies have examined the efficacy of myofascial techniques combined with thrust and nonthrust manipulation and exercises for patients post–acute lateral ankle sprain. Therefore, the purpose of this randomized clinical trial was to compare the effects of thrust and nonthrust manipulation and exercise combined with myofascial therapy to thrust and nonthrust manipulation and exercise alone, using outcomes of pain, function, mobility, and pressure pain sensitivity in individuals with acute lateral ankle sprain. METHODS Participants P atients who presented to a physical therapy clinic in Madrid, Spain from January 2011 to June 2012 with a primary report of unilateral inversion ankle sprain were screened for inclusion in this study. To be included in the study, patients had to be between 18 and 50 years of age, to report that this was their first inversion ankle sprain in the injured ankle, to have an inversion ankle sprain grade of 1 or 2, and to have been injured for less than 5 days. The diagnosis of an ankle sprain was made by each patient’s physician. Potential participants were excluded if they exhibited any of the following criteria that could have altered their pain perception: previous trauma, fracture, or surgery to the lower extremity; any concomitant lower extremity pathology, for example, vascular disease or osteoarthritis; pregnancy; any painful medical syndrome, such as fibromyalgia, rheumatoid arthritis, whiplash, or carpal tunnel syndrome; the use of pain or other medication within 7 days prior to the study; or previous physical therapy interventions provided for the foot region. The study protocol was approved by the Institutional Review Board of the Universidad Rey Juan Carlos and was conducted according to the Helsinki Declaration. All participants signed an informed consent form prior to their inclusion in the study. Outcome Measures The primary outcome measure, intensity of ankle pain at rest, was assessed with an 11-point numeric pain rating scale, where 0 represented the absence of pain and 10 represented maximum pain.19 In patients with neck pain, the minimal detectable change and the minimal clinically important difference (MCID) have been reported to be 1.3 and 2.1 points, respectively.6 However, in patients post–inversion ankle sprain, there are no available data for minimal detectable change and MCID. Secondary outcomes in this study included ankle function, active range of motion, and pressure pain sensitivity. Function was assessed using the Functional Score for Assessment of Acute Lateral Ankle Sprains, as described by de Bie et al.10 The score on this tool is based on a functional evaluation of the following 5 items: pain (0-35), instability (0-25), weight bearing (0-20), swelling (0-10), and walking pattern (0-10). The maximum total score is 100, with higher values indicating better functional status. Active range of motion of the ankle was measured using a standard goniometer.22 The patient was seated with the knee bent to 90°. The therapist aligned the axis of the goniometer over the lateral malleolus, the proximal arm with the midline of the fibula, and the distal arm parallel to the fifth metatarsal. The patient performed active plantar flexion and a measurement was recorded. Next, the patient performed active dorsiflexion and a measurement was recorded.22 The reliability of goniometric measurements of ankle plantar flexion and dorsiflexion ranges from poor to good.12,35,39 journal of orthopaedic & sports physical therapy | volume 43 | number 5 | may 2013 | 301 43-05 Truyols-Dominguez.indd 301 4/17/2013 3:50:49 PM [ research report ] FIGURE 3. Anterior/posterior nonthrust manipulation applied to the distal tibiofibular joint. FIGURE 2. Lateral glide/eversion rearfoot nonthrust manipulation technique. FIGURE 1. Anterior/posterior nonthrust manipulation of the subtalar joint. Pressure pain threshold (PPT), the amount of pressure (kg/cm2) at which the sensation of pressure changes to pain,33 was assessed with a mechanical pressure algometer (Pain Diagnosis and Treatment, Inc, Great Neck, NY). Participants were instructed to notify the tester when the pressure first changed to a pain sensation. The device consists of a round rubber disc (1 cm2) attached to a force gauge (kg). The pressure was applied at a rate of approximately 0.1 kg/cm2/s. The mean of 3 trials was calculated for each tested location and used for the main analysis. A 30-second rest was provided between each trial. The reliability of pressure algometry has been found to be high (intraclass correlation coefficient = 0.91; 95% confidence interval: 0.82, 0.97) when the testing is performed on healthy people.5 Walton et al37 recently reported the minimal detectable change for PPT measured over the cervical spine and tibialis anterior muscle in patients with acute neck pain; however, no normative data for PPT assessed over the locations used for patients post–inversion ankle sprain have been reported in the literature. To investigate the hypoalgesic effects of both treatment protocols, consistent with a previous study,26 PPT was assessed at 4 predetermined locations on the affected leg: anterior to the lateral malleolus over the anterior talofibular ligament, distal to the lateral malleolus over the calcaneofibular ligament, over the lateral malleolus, and over the medial malleolus. FIGURE 4. Talocrural joint distraction thrust manipulation technique. Study Protocol Participants were assigned by concealed random allocation, using random numbers generated by online software (www. randomization.com), to 1 of the 2 groups. The comparison group received the same thrust and nonthrust manipulation and exercise protocol as that used by Whitman et al.38 The experimental group was treated with myofascial manual therapy techniques in addition to the protocol that was also provided to the comparison group. Both groups were treated by a clinician with 5 years of postgraduate orthopaedic manual therapy training and more than 10 years of clinical experience in the management of musculoskeletal disorders. All participants were treated for 4 sessions, once per week, for 4 weeks. The treatment was applied to the affected ankle only. Outcome measures were captured at baseline, after the last treatment session, and at a 1-month follow-up. PPT and ankle mobility were assessed by a clinician blinded to group assignment. Patients were not informed of the true objective of the study, hence they did not know which intervention was being evaluated. FIGURE 5. Proximal tibiofibular joint thrust manipulation technique. Nonthrust (Mobilization) and Thrust Manipulation Interventions Both groups received the same manual therapy protocol as that used by Whitman et al,38 which included ankle and foot nonthrust (mobilization) and thrust manipulation, general exercises, and instruction to elevate and ice the ankle. Nonthrust manipulation techniques included an anterior-toposterior subtalar joint technique (FIGURE 1), a lateral glide/eversion rearfoot technique (FIGURE 2), and an anterior/posterior technique applied to the distal tibiofibular joint (FIGURE 3). Each mobilization was applied at grade 3 or 4 and was delivered for 20 to 30 seconds. The thrust manipulations included a talocrural joint distraction (FIGURE 4) and a proximal tibiofibular joint technique (FIGURE 5). 302 | may 2013 | volume 43 | number 5 | journal of orthopaedic & sports physical therapy 43-05 Truyols-Dominguez.indd 302 4/17/2013 3:50:50 PM Patients with lateral ankle sprain screened for eligibility criteria, n = 56 Excluded, n = 6: • Repetitive ankle sprain, n = 3 • Ankle sprain grade 3, n = 1 • Ankle fracture, n = 2 FIGURE 6. Pressure-release technique over the myofascial tissues of the gastrocnemius muscle. Baseline measurements, n = 50 • Pain • Function • Ankle range of motion • Pressure pain thresholds Randomized, n = 50 FIGURE 7. Static stroke over the myofascial tissues of the fibularis muscles. FIGURE 8. Cross-hand technique over the gastrocnemius myofascial tissue. More specific details of the interventions can be found in the article by Whitman et al.38 Patients also performed Achilles tendon stretching, general range-of-motion exercises, and self-mobilization of the ankle at the end of each session. In addition, patients were advised to maintain usual activity within the limits of pain. 38 Both groups received the same amount of therapy, but the intervention order was left to the therapist’s discretion, based on the findings of the clinical examination. Myofascial Therapy The myofascial intervention targeted the soft tissues of the lower leg and was not based solely on the presence of myofascial TrPs.27 Patients Allocated to the comparison group, n = 25: • 1 weekly therapy session for 4 weeks Allocated to the experimental group, n = 25: • 1 weekly therapy session for 4 weeks Postintervention, n = 25 • Pain • Function • Ankle range of motion • Pressure pain thresholds Postintervention, n = 25 • Pain • Function • Ankle range of motion • Pressure pain thresholds 1-month follow-up, n = 25 • Pain • Function • Ankle range of motion • Pressure pain thresholds 1-month follow-up, n = 25 • Pain • Function • Ankle range of motion • Pressure pain thresholds FIGURE 9. Flow diagram of patients throughout the course of the study. received pressure-release techniques over the different myofascial structures, for example, the gastrocnemius and fibularis muscles (FIGURE 6). With this technique, pressure was progressively applied over the tissue until an increase in muscle resistance (tissue barrier) was perceived. The pressure was then maintained until the therapist perceived release of the tissue. At this stage, the pressure was increased to return to the previous level of soft tissue tension, and the process was repeated 3 times. If the clinician identified a myofascial TrP (sensitive spot eliciting referred pain), the pressure was applied over the TrP. Patients were also treated with static strokes (FIGURE 7) and cross-hand interventions (FIGURE 8), applied over the gastrocnemius and tibialis anterior muscles.4 Again, with these techniques, manual pressure was maintained at the soft tissue barrier. The myofascial techniques were applied slowly and without producing pain. journal of orthopaedic & sports physical therapy | volume 43 | number 5 | may 2013 | 303 43-05 Truyols-Dominguez.indd 303 4/17/2013 3:50:51 PM [ research report ] Sample-Size Calculation TABLE 1 Baseline Demographics for Both Groups* Comparison Group (n = 25) Experimental Group (n = 25) P Value 19/6 18/7 .747 Gender (male/female), n Age, y 32 11 (28, 38) 33 9 (30, 38) .757 Height, cm 173 8.4 (170, 179) 173 8.8 (170, 178) .961 Weight, kg 66.9 11.7 (62.1, 71.8) 68.4 6.6 (65.7, 71.1) .675 Time from injury, d 3.1 0.7 (2.8, 3.4) 3.2 0.7 (2.9, 3.5) .837 Pain (0-10) 5.1 1.0 (4.4, 5.8) 5.4 2.0 (4.8, 6.1) .641 Functional score Total (0-100) 40.9 18.0 (35.2, 46.6) 38.9 8.8 (33.2, 44.6) .621 Pain (0-35) 13.2 5.5 (11.1, 15.2) 12.2 4.5 (10.1, 14.2) .591 Instability (0-25) 10.6 6.3 (8.3, 12.8) 9.6 4.7 (7.3, 11.8) .532 Weight bearing (0-20) 8.8 4.3 (7.2, 10.3) 8.6 3.0 (7.1, 10.1) .853 Swelling (0-10) 3.6 2.4 (2.8, 4.4) 3.2 1.1 (2.4, 4.0) .561 Walking pattern (0-10) 2.4 2.2 (1.4, 3.4) 2.3 2.4 (1.4, 3.3) .906 Ankle mobility, deg Plantar flexion 26.6 10.0 (22.8, 30.5) 25.8 8.9 (22.0, 30.0) .760 Dorsiflexion 12.8 6.2 (10.4, 15.1) 11.9 5.5 (9.5, 14.2) .583 Anterior talofibular ligament 4.9 1.2 (4.5, 5.3) 4.6 0.9 (4.3, 5.1) .606 Calcaneofibular ligament 5.8 1.2 (5.1, 6.4) 5.5 1.8 (5.0, 6.2) .694 Lateral malleolus 6.2 1.8 (5.5, 6.9) 5.9 1.8 (5.1, 6.6) .627 Medial malleolus 5.9 1.9 (5.2, 6.7) 6.1 1.9 (5.3, 6.8) .836 Pressure pain threshold, kg/cm2 *Values are mean SD (95% confidence interval), except for gender. TABLE 2 Experimental Group (n = 25) Pain intensity (0-10) Pretreatment 5.1 1.0 5.4 2.0 Posttreatment 3.2 1.5 2.1 1.4 Follow-up 2.0 1.2 Pre/post within-group change scores –1.9 (–2.4, –1.3) Pre/post between-group change scores Pre/follow-up within-group change scores Pre/follow-up between-group change scores 0.7 0.5 –3.4 (–4.3, –2.5) 1.5 (1.0, 2.2) –3.1 (–3.7, –2.4) –4.7 (–5.5, –4.0) 1.6 (1.1, 2.1) Total functional scores (0-100) Pretreatment 40.9 18.0 38.9 8.8 Posttreatment 64.0 17.8 78.6 13.9 Follow-up 82.2 11.8 97.1 4.6 Pre/post within-group change scores 23.1 (16.1, 30.0) 39.7 (33.2, 46.1) Pre/post between-group change scores 16.6 (7.3, 25.8) Pre/follow-up within-group change scores 41.3 (31.5, 51.0) Pre/follow-up between-group change scores 16.9 (6.4, 27.3) Adverse Events All participants were asked to report any adverse events experienced after the intervention and during the 1-month follow-up period. An adverse event was defined as sequelae of medium-term duration of any symptom perceived as distressing and unacceptable to the patient and that required further treatment. Statistical Analysis Outcome Data for Pain Intensity and Total Functional Score* Comparison Group (n = 25) The sample-size calculations were performed with the ENE 3.0 software (Universitat Autònoma de Barcelona, Barcelona, Spain). The calculations were based on detecting a mean difference of 2.1 points (MCID) on an 11-point numeric pain rating scale,6 assuming a standard deviation of 2.1, a 2-tailed test, an alpha level of .05, and a desired power of 90%. The estimated desired sample size was 22 patients per group. To accommodate expected dropouts before study completion, a total of 25 participants were included in each group. 58.2 (53.6, 63.0) Abbreviations: Pre/follow-up, pretreatment to 1-month follow-up; Pre/post, pretreatment to immediately posttreatment. *Values are mean SD, except for change scores, which are mean (95% confidence interval). Data were analyzed with SPSS Version 18.0 (SPSS Inc, Chicago, IL), and the analysis was conducted following an intention-to-treat analysis. When any postintervention data were missing, previous scores that would reflect a conservative approach to handling missing data were used. Means, standard deviations, and 95% confidence intervals were calculated for each variable. The Kolmogorov-Smirnov test showed a normal distribution of quantitative data. Potential differences in baseline demographic and clinical variables between the 2 groups were analyzed using independent Student t tests for continuous data and chi-square tests of independence for categorical data. Separate 2-by-3 mixed-model analyses of variance were used to examine the effects of treatment on pain intensity, functional score, ankle plantar flexion and dorsiflexion range of motion, and PPTs as the dependent variables, with group (experimental, control) as the between-subject variable and 304 | may 2013 | volume 43 | number 5 | journal of orthopaedic & sports physical therapy 43-05 Truyols-Dominguez.indd 304 4/17/2013 3:50:52 PM time (baseline, posttreatment, 1-month follow-up) as the within-subject variable. Between-group effect sizes were calculated using the Cohen d coefficient (between-group differences divided by mean standard deviation).7 An effect size greater than 0.8 was considered large, around 0.5 moderate, and less than 0.2 small.7 The finding of interest was the group-by-time interaction at an a priori alpha level equal to .05. RESULTS F ifty-six consecutive individuals with acute inversion ankle sprain were screened for eligibility criteria. Fifty patients (mean SD age, 33 10 years; 26% female; weight, 68 9 kg; height, 173 8 cm) satisfied all eligibility criteria, agreed to participate, and were randomized to either the comparison (n = 25) or experimental (n = 25) group. The reasons for ineligibility are found in FIGURE 9, which provides a flow diagram of patient recruitment and retention. Baseline features between groups were similar for all variables (TABLE 1). No patient reported any adverse event during the study period. The 2-by-3 mixed-model analysis of variance revealed significant group-bytime interactions for pain (F = 11.727, P<.001) and functional score (F = 10.466, P = .002), with the patients who received the combined treatment of myofascial manual therapy, nonthrust (mobilization) and thrust manipulation, and exercises experiencing a greater reduction in pain and a greater improvement in function than those who received the intervention of nonthrust and thrust manipulation and exercises. These outcomes were observed both immediately after the 4-week intervention (P<.001) and at 1-month follow-up (P = .003). Between-group effect sizes were large (d>1.3) for both outcomes at the end of the intervention and 1 month postintervention (TABLE 2). The group-by-time interaction was statistically significant for all domains of the functional score (pain: F = 6.826, TABLE 3 Outcome Data for Each Domain of the Functional Score* Comparison Group (n = 25) Experimental Group (n = 25) Pretreatment 13.2 5.5 12.2 4.5 Posttreatment 22.2 8.3 27.7 11.4 Follow-up 28.4 7.2 35.6 12.1 Pain (0-35) Pre/post within-group change scores 9.0 (5.5, 12.4) Pre/post between-group change scores 6.5 (1.7, 12.2) Pre/follow-up within-group change scores 15.2 (11.2, 19.2) Pre/follow-up between-group change scores 8.2 (2.9, 14.5) 15.5 (10.7, 20.3) 23.4 (18.3, 28.5) Instability (0-25) Pretreatment 10.6 6.3 9.6 4.7 Posttreatment 17.2 8.2 19.6 5.2 Follow-up 19.6 7.5 24.4 2.2 Pre/post within-group change scores 6.6 (4.0, 9.2) 10.0 (7.8, 12.3) Pre/post between-group change scores 3.4 (1.0, 5.7) Pre/follow-up within-group change scores 9.0 (5.8, 12.2) Pre/follow-up between-group change scores 5.8 (2.1, 9.6) 14.8 (12.5, 17.1) Weight bearing (0-20) Pretreatment 8.8 4.3 8.6 3.0 Posttreatment 11.8 6.8 17.0 3.8 Follow-up 16.8 4.7 20.2 2.3 Pre/post within-group change scores 3.0 (1.0, 6.9) Pre/post between-group change scores 5.4 (1.0, 9.7) Pre/follow-up within-group change scores 8.0 (5.0, 10.9) Pre/follow-up between-group change scores 3.6 (1.3, 5.9) 8.4 (6.4, 10.3) 11.6 (10.0, 13.1) Swelling (0-10) Pretreatment 3.6 2.4 Posttreatment 6.6 2.5 3.2 1.1 7.6 2.2 Follow-up 8.2 2.0 10.2 1.0 Pre/post within-group change scores 3.0 (2.1, 3.9) Pre/post between-group change scores 1.4 (0.2, 2.6) Pre/follow-up within-group change scores 4.6 (3.5, 5.7) Pre/follow-up between-group change scores 2.4 (1.1, 3.5) 4.4 (3.7, 5.2) 7.0 (6.5, 7.4) Walking pattern (0-10) Pretreatment 2.4 2.2 2.3 2.4 Posttreatment 6.5 2.5 6.8 2.4 Follow-up 7.3 2.1 9.2 1.9 Pre/post within-group change scores 4.1 (3.2, 4.9) 4.5 (3.2, 5.7) Pre/post between-group change scores 0.4 (–1.2, 1.8) Pre/follow-up within-group change scores 4.9 (3.8, 6.0) Pre/follow-up between-group change scores 2.0 (0.3, 3.6) 6.9 (5.6, 8.2) Abbreviations: Pre/follow-up, pretreatment to 1-month follow-up; Pre/post, pretreatment to immediately posttreatment. *Values are mean SD, except for change scores, which are mean (95% confidence interval). P = .012; instability: F = 4.570, P = .013; weight bearing: F = 4.890, P = .010; swelling: F = 7.961, P = .001; walking pat- tern: F = 4.221, P = .017), with patients who received the combined-treatment approach experiencing greater improve- journal of orthopaedic & sports physical therapy | volume 43 | number 5 | may 2013 | 305 43-05 Truyols-Dominguez.indd 305 4/17/2013 3:50:53 PM [ ment on each domain compared to those in the comparison group. These outcomes were observed both immediately after the last therapy session and at 1-month follow-up (P<.01). Between-group effect sizes ranged from moderate (d = 0.65) to large (d = 1.0), depending on the domain (TABLE 3). The 2-by-3 mixed-model analysis of variance also revealed significant groupby-time interactions for plantar flexion (F = 18.394, P<.001) and dorsiflexion (F = 19.009, P<.001) range of motion and for PPTs (anterior talofibular ligament: F = 45.601, P<.001; calcaneofibular ligament: F = 7.954, P<.001; lateral malleolus: F = 16.339, P<.001; medial malleolus: F = 8.599, P = .005), with patients who received the combination of nonthrust and thrust manipulation, exercises, and myofascial manual therapy experiencing greater increases in ankle mobility and PPTs compared to those who received the comparison intervention, both immediately after the last therapy session and at 1-month follow-up (P<.01). Betweengroup effect sizes were large (d>0.85) for all secondary outcomes (TABLES 4 and 5). DISCUSSION T he results of this study suggest that the combination of myofascial manual therapy techniques and joint nonthrust and thrust manipulation techniques and exercises to treat individuals with acute ankle sprains may result in better outcomes after 4 weeks of therapy and 1 month after the end of therapy than joint nonthrust and thrust manipulation and exercises alone. It should be noted that although between-group change scores were statistically significant, they did not surpass the previously reported MCID for the primary outcome measure (pain). Additionally, for the muscles tested in the present study, there are no reported values for the MCID of PPT in individuals after ankle inversion sprain; however, the present study showed large effect sizes for PPT. Therefore, the benefit of adding myofascial treatment may be research report TABLE 4 ] Outcome Data for Ankle Mobility* Comparison Group (n = 25) Experimental Group (n = 25) Ankle plantar flexion, deg Pretreatment 26.6 10.0 25.8 8.9 Posttreatment 34.7 8.8 39.6 8.3 Follow-up 37.1 8.5 47.9 9.5 Pre/post within-group change scores 8.1 (4.2, 11.9) 13.8 (10.8, 16.8) Pre/post between-group change scores 5.7 (1.9, 10.5) Pre/follow-up within-group change scores 10.5 (6.2, 14.8) Pre/follow-up between-group change scores 11.6 (6.2, 17.1) 22.1 (18.6, 25.7) Ankle dorsiflexion, deg Pretreatment 12.8 6.2 11.9 5.5 Posttreatment 15.7 5.3 23.2 5.2 Follow-up 20.2 8.3 28.8 6.1 Pre/post within-group change scores 2.9 (0.4, 5.4) Pre/post between-group change scores 8.4 (5.2, 11.7) Pre/follow-up within-group change scores 7.4 (4.3, 10.6) Pre/follow-up between-group change scores 9.5 (5.1, 13.8) 11.3 (9.2, 13.5) 16.9 (13.8, 20.1) Abbreviations: Pre/follow-up, pretreatment to 1-month follow-up; Pre/post, pretreatment to immediately posttreatment. *Values are mean SD, except for change scores, which are mean (95% confidence interval). clinically relevant, as indicated by moderate to large between-group effect sizes and by between-group differences in all outcomes. Because the addition of myofascial manual therapy resulted in statistically greater and potentially greater clinical improvements in pain and function, we hypothesize that soft tissues may perpetuate symptoms associated with lateral ankle sprains. It is plausible that the muscles surrounding the ankle, in an attempt to protect the ankle from further trauma, go into a protective state. The exact mechanism by which the treatment of soft tissues, including TrPs, is effective remains to be elucidated. However, it is possible that the treatment results in a restoration of the length of the sarcomeres, resulting in a reduction of pain. 31 The restoration of sarcomere length may also be related, at least in part, to the greater improvements in ankle mobility observed in those patients who received the soft tissue myofascial approach. Another explanation may be that the treatment of myofascial soft tissue struc- tures results in segmental antinociceptive effects.32 It has also recently been demonstrated that localized mechanical pain hypersensitivity over ankle ligaments and the lateral malleolus exists in individuals with lateral ankle sprains.26 This suggests that the peripheral sensitization secondary to the acuteness of the injury post– lateral ankle sprain may be positively affected by myofascial techniques.26 We also found significantly greater increases in PPTs over the affected leg in the experimental group. Again, effect sizes were large, supporting a clinical effect of the intervention over mechanical sensitivity in those points previously found to be hypersensitive. Our results would, therefore, support the antinociceptive effect of myofascial interventions. Whitman et al38 found that 75% of individuals who received nonthrust and thrust manipulation interventions, Achilles tendon stretching, general range-ofmotion exercises, and self-mobilization of the ankle experienced a successful outcome with 2 physical therapy sessions. It is possible that a greater percentage of 306 | may 2013 | volume 43 | number 5 | journal of orthopaedic & sports physical therapy 43-05 Truyols-Dominguez.indd 306 4/17/2013 3:50:54 PM TABLE 5 Outcome Data for Pressure Pain Sensitivity* Comparison Group (n = 25) Experimental Group (n = 25) Pretreatment 4.9 1.2 4.6 0.9 Posttreatment 5.7 1.3 7.9 1.0 Follow-up 6.3 1.2 9.1 0.8 Pre/post within-group change scores 0.8 (0.4, 1.3) 3.3 (2.6, 3.9) Pre/post between-group change scores 2.5 (1.7, 3.2) Anterior talofibular ligament, kg/cm2 Pre/follow-up within-group change scores 1.4 (0.9, 1.9) Pre/follow-up between-group change scores 3.1 (2.4, 3.8) 4.5 (4.0, 5.0) Calcaneofibular ligament, kg/cm2 Pretreatment 5.8 1.2 5.5 1.8 Posttreatment 7.5 1.8 8.3 1.5 Follow-up 8.2 1.5 9.4 0.6 Pre/post within-group change scores 1.7 (1.1, 2.2) 2.8 (2.1, 3.3) Pre/post between-group change scores 1.1 (0.3, 1.8) Pre/follow-up within-group change scores 2.4 (1.8, 2.9) Pre/follow-up between-group change scores 1.5 (0.6, 2.2) 3.9 (3.2, 4.5) Medial malleolus, kg/cm2 Pretreatment 5.9 1.9 6.1 1.9 Posttreatment 7.1 2.0 8.3 1.3 Follow-up 8.0 1.8 9.6 0.7 Pre/post within-group change scores 1.2 (0.5, 1.8) 2.2 (1.5, 2.9) Pre/post between-group change scores 1.0 (0.1, 1.9) Pre/follow-up within-group change scores 2.1 (1.2, 2.7) Pre/follow-up between-group change scores 1.4 (0.5, 2.6) 3.5 (2.7, 4.4) Lateral malleolus, kg/cm2 Pretreatment 6.2 1.8 5.9 1.8 Posttreatment 7.4 1.6 8.1 1.3 Follow-up 8.0 1.5 9.6 0.7 Pre/post within-group change scores 1.2 (0.6, 1.6) 2.2 (1.6, 2.8) Pre/post between-group change scores 1.0 (0.2, 1.8) Pre/follow-up within-group change scores 1.8 (1.1, 2.4) Pre/follow-up between-group change scores 1.9 (1.0, 2.9) 3.7 (2.9, 4.4) Abbreviations: Pre/follow-up, pretreatment to 1-month follow-up; Pre/post, pretreatment to immediately posttreatment. *Values are mean SD, except for change scores, which are mean (95% confidence interval). patients would experience a successful outcome if the current myofascial treatment were added as an intervention; although future studies are needed to confirm this assumption. Additionally, Whitman et al38 used patient-perceived improvement as an outcome measure to determine success. As the current study did not use such a self-report measure, its success rate cannot be directly compared to theirs. However, it is interest- ing to note that patients in the study by Whitman et al38 experienced a decrease in ankle pain very similar to the pain decreases measured in our comparison group, which was expected, given the use of the same nonthrust and thrust manipulation protocol. It is suggested that thrust manipulation induces presynaptic inhibition of segmental pathways, reflex pain inhibition, reflex muscle relaxation, or changes in proprioceptive afferences.25 The most current accepted theory is that manual therapy in general, including soft tissue myofascial interventions, acts over central pain control by stimulating descending inhibitory pain mechanisms, particularly the periaqueductal gray area.3 It is possible that the effects of nonthrust and thrust manipulation interventions are complementary to the application of myofascial interventions for the management of acute ankle sprain. The data also indicated that individuals in both groups experienced statistically and clinically significant improvements in both pain and function over time, with the lower bound of the 95% confidence interval for within-group changes in both groups being larger than the MCID for pain, the primary outcome. But the lack of a control group that did not receive any intervention precludes determining how much of that improvement in both groups was due to the natural resolution of the condition. Similarly, influence of the placebo effect in both groups is unknown, as the study did not include a sham-intervention group.14 There are a number of limitations in the current study. Only 1 therapist provided the treatment, which may limit the generalizability of the results. It is also possible that attention bias occurred, as the patients receiving myofascial therapy spent more time with the therapist at each treatment session. Furthermore, the final follow-up assessment took place at 1 month, and it is uncertain whether the observed differences might remain beyond that time. In addition, we did not assess the perspective of the patients about the progress of their ankle sprain by using a self-report evaluation, such as the global rating of change. Finally, although statistically significant, between-group differences were not clinically meaningful, so the actual clinical relevance of myofascial interventions requires further study, perhaps with the addition of self-reported outcome measures such as the global rating of change, the Lower Extremity Functional Scale, and the Patient-Specific Functional Scale. journal of orthopaedic & sports physical therapy | volume 43 | number 5 | may 2013 | 307 43-05 Truyols-Dominguez.indd 307 4/17/2013 3:50:55 PM [ Future clinical trials should include multiple therapists delivering the intervention, a true control group, and long-term follow-up. CONCLUSION T his study provides evidence that the addition of myofascial techniques to a treatment protocol of thrust and nonthrust manipulation and exercise in individuals with acute ankle sprains results in statistically significant improvement in pain and function. These results should be interpreted with regard to these differences being smaller than what would be considered a clinically important difference, despite the fact that the effect size of the between-group difference was considered large. Future studies should include a true control group and examine the long-term effects of these interventions in this population, in addition to further assessment of the clinical significance of the changes. t KEY POINTS FINDINGS: The addition of myofascial techniques to an intervention of thrust and nonthrust joint manipulation and exercise in the treatment of acute ankle sprain leads to statistically significantly greater improvement in pain and function immediately after a 4-week intervention and at 1-month follow-up. IMPLICATIONS: Physical therapists may consider incorporating soft tissue myofascial manual techniques in the overall management of individuals with acute inversion ankle sprains. 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