10
300 |  may 2013  |  volume 43  |  number 5  |  journal of orthopaedic & sports physical therapy [ RESEARCH REPORT ] L 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 func- tional impairment. 18 Despite the assump- tion 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 estab- lished. 15 Among ankle sprains, grades 1 and 2 are more likely to recur. 21 Current evidence indicates that man- ual therapy interventions, such as joint mobilization and manipulation, and exer- cises are often used by physical therapists to manage patients who have sustained an ankle sprain. 2,29,30 The authors of sev- T T STUDY DESIGN: Randomized clinical trial. T T OBJECTIVE: 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. T T BACKGROUND: 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. T T METHODS: 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 interven- tion, 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. T T RESULTS: The 2-by-3 mixed-model analyses of variance revealed a significant group-by-time interac- tion for ankle pain (P<.001) and functional score (P = .002), with the patients who received the combi- nation of nonthrust and thrust manipulation and myo- fascial intervention experiencing a greater improve- ment in pain and function than those who received the nonthrust and thrust manipulation intervention alone. Significant group-by-time interactions were also ob- served 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. T T CONCLUSION: 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 ma- nipulation and exercise may further improve out- comes compared to a plan of care solely consisting of thrust and nonthrust manipulation and exercise. However, though statistically significant, the dif- ference in improvement in the primary outcome between groups was not greater than what would be considered a minimal clinically important differ- ence. Future studies should examine the long-term effects of these interventions in this population. T T LEVEL 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 T T KEY WORDS: manual therapy, pressure pain threshold, triceps surae 1 Department of Physical Therapy, Universidad Camilo José Cela, Madrid, Spain. 2 Department of Physical Therapy, Occupational Therapy, Rehabilitation and Physical Medicine, Universidad Rey Juan Carlos, Alcorcón, Madrid, Spain. 3 Department of Physical Therapy, Franklin Pierce University, Concord, NH. 4 Rehabilitation Services, Concord Hospital, Concord, NH. 5 Manual 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: [email protected] T Copyright ©2013 Journal of Orthopaedic & Sports Physical Therapy ® SEBASTIÁN TRUYOLS-DOMÍNGUEZ, PT, PhD 1 JAIME SALOM-MORENO, PT 2 JAVIER ABIAN-VICEN, PT, PhD 1 JOSHUA A. CLELAND, PT, PhD 3-5 CÉSAR FERNÁNDEZ-DE-LAS-PEÑAS, PT, PhD 2 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

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Page 1: Efficacy of Thrust and Nonthrust Manipulation and Exercise With or

300  |  may 2013  |  volume 43  |  number 5  |  journal of orthopaedic & sports physical therapy

[ research report ]

Lateral 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 func-tional impairment.18 Despite the assump-tion 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 estab-lished.15 Among ankle sprains, grades 1 and 2 are more likely to recur.21

Current evidence indicates that man-ual therapy interventions, such as joint mobilization and manipulation, and exer-cises are often used by physical therapists to manage patients who have sustained an ankle sprain.2,29,30 The authors of sev-

TT STUDY DESIGN: Randomized clinical trial.

TT OBJECTIVE: 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.

TT BACKGROUND: 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.

TT METHODS: 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 interven-tion, 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.

TT RESULTS: The 2-by-3 mixed-model analyses of variance revealed a significant group-by-time interac-tion for ankle pain (P<.001) and functional score

(P = .002), with the patients who received the combi-nation of nonthrust and thrust manipulation and myo-fascial intervention experiencing a greater improve-ment in pain and function than those who received the nonthrust and thrust manipulation intervention alone. Significant group-by-time interactions were also ob-served 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.

TT CONCLUSION: 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 ma-nipulation and exercise may further improve out-comes compared to a plan of care solely consisting of thrust and nonthrust manipulation and exercise. However, though statistically significant, the dif-ference in improvement in the primary outcome between groups was not greater than what would be considered a minimal clinically important differ-ence. Future studies should examine the long-term effects of these interventions in this population.

TT LEVEL 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

TT KEY WORDS: manual therapy, pressure pain threshold, triceps surae

1Department 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: [email protected] T Copyright ©2013 Journal of Orthopaedic & Sports Physical Therapy®

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

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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 re-cent systematic review34 concluded that, though manual mobilization has an ini-tial 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 sub-acute inversion ankle sprain who would be likely to benefit from manual therapy interventions and a general exercise pro-tocol targeted to the ankle/foot. In this study, 75% of all patients exhibited a suc-cessful outcome.38 Hence, it is possible that the majority of individuals with lat-eral ankle sprain may benefit from such a treatment approach. However, a cause-and-effect relationship, in the absence of a comparison group, cannot be directly inferred from this cohort study.

Despite all the aforementioned stud-ies that included manual therapy inter-ventions, none incorporated myofascial techniques. An example of the potential effectiveness of adding myofascial tech-niques to a manual therapy approach was demonstrated in a randomized con-trolled trial on patients with plantar fas-ciosis.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 treat-ment 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 func-tion 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, fibular-is) may attempt to protect the ligaments from further trauma by creating a protec-tive 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 com-pare the effects of thrust and nonthrust manipulation and exercise combined with myofascial therapy to thrust and non-thrust manipulation and exercise alone, using outcomes of pain, function, mobil-ity, and pressure pain sensitivity in indi-viduals with acute lateral ankle sprain.

METHODS

Participants

Patients 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 di-agnosis of an ankle sprain was made by each patient’s physician. Potential par-ticipants were excluded if they exhibited any of the following criteria that could have altered their pain perception: pre-vious trauma, fracture, or surgery to the lower extremity; any concomitant lower extremity pathology, for example, vascu-lar disease or osteoarthritis; pregnancy; any painful medical syndrome, such as fibromyalgia, rheumatoid arthritis, whip-lash, 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 ap-proved 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 in-clusion in the study.

Outcome MeasuresThe 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 impor-tant difference (MCID) have been report-ed to be 1.3 and 2.1 points, respectively.6 However, in patients post–inversion an-kle 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 Func-tional 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 goniom-eter.22 The patient was seated with the knee bent to 90°. The therapist aligned the axis of the goniometer over the lat-eral 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

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[ research report ]

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 Treat-ment, Inc, Great Neck, NY). Participants were instructed to notify the tester when the pressure first changed to a pain sensa-tion. The device consists of a round rub-ber 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 al-gometry has been found to be high (intra-class 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 mini-mal detectable change for PPT measured over the cervical spine and tibialis ante-rior 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 as-sessed 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 me-dial malleolus.

Study ProtocolParticipants were assigned by concealed random allocation, using random num-bers 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 Whit-man et al.38 The experimental group was treated with myofascial manual therapy techniques in addition to the protocol that was also provided to the compari-son 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 an-kle 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.

Nonthrust (Mobilization) and Thrust Manipulation Interventions Both groups received the same manual therapy proto-col as that used by Whitman et al,38 which included ankle and foot nonthrust (mo-bilization) and thrust manipulation, gen-eral exercises, and instruction to elevate and ice the ankle. Nonthrust manipula-tion techniques included an anterior-to-posterior subtalar joint technique (FIGURE

1), a lateral glide/eversion rearfoot tech-nique (FIGURE 2), and an anterior/pos-terior technique applied to the distal tibiofibular joint (FIGURE 3). Each mobi-lization was applied at grade 3 or 4 and was delivered for 20 to 30 seconds. The thrust manipulations included a talocru-ral joint distraction (FIGURE 4) and a proxi-mal tibiofibular joint technique (FIGURE 5).

FIGURE 1. Anterior/posterior nonthrust manipulation of the subtalar joint.

FIGURE 2. Lateral glide/eversion rearfoot nonthrust manipulation technique.

FIGURE 3. Anterior/posterior nonthrust manipulation applied to the distal tibiofibular joint.

FIGURE 4. Talocrural joint distraction thrust manipulation technique.

FIGURE 5. Proximal tibiofibular joint thrust manipulation technique.

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More specific details of the interventions can be found in the article by Whitman et al.38 Patients also performed Achilles ten-don stretching, general range-of-motion exercises, and self-mobilization of the ankle at the end of each session. In ad-dition, 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 in-tervention targeted the soft tissues of the lower leg and was not based solely on the presence of myofascial TrPs.27 Patients

received pressure-release techniques over the different myofascial structures, for example, the gastrocnemius and fibu-laris muscles (FIGURE 6). With this tech-nique, 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 tis-sue. At this stage, the pressure was in-creased to return to the previous level of soft tissue tension, and the process was

repeated 3 times. If the clinician iden-tified 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), ap-plied over the gastrocnemius and tibialis anterior muscles.4 Again, with these tech-niques, manual pressure was maintained at the soft tissue barrier. The myofascial techniques were applied slowly and with-out producing pain.

FIGURE 6. Pressure-release technique over the myofascial tissues of the gastrocnemius muscle.

FIGURE 7. Static stroke over the myofascial tissues of the fibularis muscles.

FIGURE 8. Cross-hand technique over the gastrocnemius myofascial tissue.

Patients with lateral ankle sprain screened for eligibility criteria, n = 56

Baseline measurements, n = 50• Pain• Function• Ankle range of motion• Pressure pain thresholds

Postintervention, n = 25• Pain• Function• Ankle range of motion• Pressure pain thresholds

Postintervention, n = 25• Pain• Function• Ankle range of motion• Pressure pain thresholds

Excluded, n = 6:• Repetitive ankle sprain, n = 3• Ankle sprain grade 3, n = 1• Ankle fracture, n = 2

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

Randomized, n = 50

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.

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[ research report ]Sample-Size CalculationThe sample-size calculations were per-formed 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 numer-ic 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 ex-pected dropouts before study completion, a total of 25 participants were included in each group.

Adverse EventsAll 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 du-ration of any symptom perceived as dis-tressing and unacceptable to the patient and that required further treatment.

Statistical AnalysisData 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 con-servative approach to handling missing data were used. Means, standard devia-tions, and 95% confidence intervals were calculated for each variable. The Kol-mogorov-Smirnov test showed a normal distribution of quantitative data. Poten-tial differences in baseline demographic and clinical variables between the 2 groups were analyzed using indepen-dent 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 vari-ables, with group (experimental, control) as the between-subject variable and

TABLE 1 Baseline Demographics for Both Groups*

*Values are mean SD (95% confidence interval), except for gender.

Comparison Group (n = 25) Experimental Group (n = 25) P Value

Gender (male/female), n 19/6 18/7 .747

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

Pressure pain threshold, kg/cm2

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

TABLE 2Outcome Data for Pain Intensity   

and Total Functional Score*

Abbreviations: Pre/follow-up, pretreatment to 1-month follow-up; Pre/post, pretreatment to immedi-ately posttreatment.*Values are mean SD, except for change scores, which are mean (95% confidence interval).

Comparison Group (n = 25) 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 0.7 0.5

Pre/post within-group change scores –1.9 (–2.4, –1.3) –3.4 (–4.3, –2.5)

Pre/post between-group change scores 1.5 (1.0, 2.2)

Pre/follow-up within-group change scores –3.1 (–3.7, –2.4) –4.7 (–5.5, –4.0)

Pre/follow-up between-group change scores 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) 58.2 (53.6, 63.0)

Pre/follow-up between-group change scores 16.9 (6.4, 27.3)

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time (baseline, posttreatment, 1-month follow-up) as the within-subject vari-able. 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

Fifty-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 pa-tient reported any adverse event during the study period.

The 2-by-3 mixed-model analysis of variance revealed significant group-by-time 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 ob-served both immediately after the 4-week intervention (P<.001) and at 1-month follow-up (P = .003). Between-group ef-fect sizes were large (d>1.3) for both out-comes 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,

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-

TABLE 3Outcome Data for Each Domain

of the Functional Score*

Abbreviations: Pre/follow-up, pretreatment to 1-month follow-up; Pre/post, pretreatment to immedi-ately posttreatment.*Values are mean SD, except for change scores, which are mean (95% confidence interval).

Comparison Group (n = 25) Experimental Group (n = 25)

Pain (0-35)

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

Pre/post within-group change scores 9.0 (5.5, 12.4) 15.5 (10.7, 20.3)

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) 23.4 (18.3, 28.5)

Pre/follow-up between-group change scores 8.2 (2.9, 14.5)

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) 14.8 (12.5, 17.1)

Pre/follow-up between-group change scores 5.8 (2.1, 9.6)

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) 8.4 (6.4, 10.3)

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) 11.6 (10.0, 13.1)

Pre/follow-up between-group change scores 3.6 (1.3, 5.9)

Swelling (0-10)

Pretreatment 3.6 2.4 3.2 1.1

Posttreatment 6.6 2.5 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) 4.4 (3.7, 5.2)

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) 7.0 (6.5, 7.4)

Pre/follow-up between-group change scores 2.4 (1.1, 3.5)

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) 6.9 (5.6, 8.2)

Pre/follow-up between-group change scores 2.0 (0.3, 3.6)

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[ research report ]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 group-by-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 re-ceived 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 imme-diately after the last therapy session and at 1-month follow-up (P<.01). Between-group effect sizes were large (d>0.85) for all secondary outcomes (TABLES 4 and 5).

DISCUSSION

The results of this study suggest that the combination of myofascial manual therapy techniques and joint

nonthrust and thrust manipulation tech-niques 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 mea-sure (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

clinically relevant, as indicated by mod-erate 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 per-petuate symptoms associated with lat-eral ankle sprains. It is plausible that the muscles surrounding the ankle, in an at-tempt 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 sarco-meres, 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 dem-onstrated 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 second-ary 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 ex-perimental 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, there-fore, support the antinociceptive effect of myofascial interventions.

Whitman et al38 found that 75% of individuals who received nonthrust and thrust manipulation interventions, Achil-les tendon stretching, general range-of-motion exercises, and self-mobilization of the ankle experienced a successful outcome with 2 physical therapy sessions. It is possible that a greater percentage of

TABLE 4 Outcome Data for Ankle Mobility*

Abbreviations: Pre/follow-up, pretreatment to 1-month follow-up; Pre/post, pretreatment to immedi-ately posttreatment.*Values are mean SD, except for change scores, which are mean (95% confidence interval).

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) 22.1 (18.6, 25.7)

Pre/follow-up between-group change scores 11.6 (6.2, 17.1)

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) 11.3 (9.2, 13.5)

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) 16.9 (13.8, 20.1)

Pre/follow-up between-group change scores 9.5 (5.1, 13.8)

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patients would experience a successful outcome if the current myofascial treat-ment 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 com-pared 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 ma-nipulation 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 stimulat-ing descending inhibitory pain mecha-nisms, particularly the periaqueductal gray area.3 It is possible that the effects of nonthrust and thrust manipulation in-terventions are complementary to the ap-plication of myofascial interventions for the management of acute ankle sprain.

The data also indicated that individu-als in both groups experienced statistical-ly 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 un-known, as the study did not include a sham-intervention group.14

There are a number of limitations in the current study. Only 1 therapist pro-vided 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 pa-tients about the progress of their ankle sprain by using a self-report evaluation, such as the global rating of change. Fi-nally, although statistically significant, between-group differences were not clinically meaningful, so the actual clini-cal relevance of myofascial interventions requires further study, perhaps with the addition of self-reported outcome mea-sures such as the global rating of change, the Lower Extremity Functional Scale, and the Patient-Specific Functional Scale.

TABLE 5 Outcome Data for Pressure Pain Sensitivity*

Abbreviations: Pre/follow-up, pretreatment to 1-month follow-up; Pre/post, pretreatment to immedi-ately posttreatment.*Values are mean SD, except for change scores, which are mean (95% confidence interval).

Comparison Group (n = 25) Experimental Group (n = 25)

Anterior talofibular ligament, kg/cm2

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)

Pre/follow-up within-group change scores 1.4 (0.9, 1.9) 4.5 (4.0, 5.0)

Pre/follow-up between-group change scores 3.1 (2.4, 3.8)

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) 3.9 (3.2, 4.5)

Pre/follow-up between-group change scores 1.5 (0.6, 2.2)

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) 3.5 (2.7, 4.4)

Pre/follow-up between-group change scores 1.4 (0.5, 2.6)

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) 3.7 (2.9, 4.4)

Pre/follow-up between-group change scores 1.9 (1.0, 2.9)

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[ research report ]Future clinical trials should include mul-tiple therapists delivering the interven-tion, a true control group, and long-term follow-up.

CONCLUSION

This  study  provides  evidence that the addition of myofascial tech-niques 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 POINTSFINDINGS: 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 func-tion immediately after a 4-week inter-vention and at 1-month follow-up.IMPLICATIONS: Physical therapists may consider incorporating soft tissue myo-fascial manual techniques in the overall management of individuals with acute inversion ankle sprains.CAUTION: Although statistically signifi-cant, the difference in improvement for pain between groups was less than what would be considered an MCID. We only assessed short-term outcomes, and only 1 therapist performed all interventions.

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