Effects of midfoot joint mobilization on ankle-foot morphology and function following acute ankle sprain. A crossover clinical trial

Journal Pre-proof Effects of midfoot joint mobilization on ankle-foot morphology and function following acute ankle sprain. A crossover clinical trial John J. Fraser, Susan A. Saliba, Joseph M. Hart, Joseph S. Park, Jay Hertel PII:

S2468-7812(19)30149-3

DOI:

https://doi.org/10.1016/j.msksp.2020.102130

Reference:

MSKSP 102130

To appear in:

Musculoskeletal Science and Practice

Received Date: 2 May 2019 Revised Date:

23 January 2020

Accepted Date: 4 February 2020

Please cite this article as: Fraser, J.J., Saliba, S.A., Hart, J.M., Park, J.S., Hertel, J., Effects of midfoot joint mobilization on ankle-foot morphology and function following acute ankle sprain. A crossover clinical trial, Musculoskeletal Science and Practice (2020), doi: https://doi.org/10.1016/ j.msksp.2020.102130. This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. © 2020 Published by Elsevier Ltd.

Title: Effects of midfoot joint mobilization on ankle-foot morphology and function following acute ankle sprain. A crossover clinical trial.

Authors: John J. Fraser, PT, DPT, PhD1, 2 Susan A. Saliba, PT, PhD, ATC1 Joseph M. Hart, PhD, ATC1 Joseph S. Park, MD3 Jay Hertel, PhD, ATC 1

Affiliations: 1. Department of Kinesiology, University of Virginia, 210 Emmet Street South, Charlottesville, VA 22904-4407, USA; 2. Warfighter Performance Department, Naval Health Research Center, USA 3. Department of Orthopaedic Surgery, University of Virginia, Charlottesville, VA, USA

Conflicts of Interest: I affirm that I have no financial affiliation or involvement with any commercial, organization that has a direct financial interest in any matter included in this manuscript.

Disclosures: This study was funded in part by the University of Virginia’s Curry School of Education Foundation and the Navy Medicine Professional Development Center. The views expressed in this manuscript reflect the results of research conducted by the author(s) and do not necessarily reflect the official policy or position of the Department of the Navy, Department of

Defense, nor the U.S. Government. Lieutenant Commander John J. Fraser is a military service member and this work was prepared as part of his official duties. Title 17, USC, §105 provides that ‘Copyright protection under this title is not available for any work of the U.S. Government.’ Title 17, USC, §101 defines a U.S. Government work as a work prepared by a military service member or employee of the U.S. Government as part of that person’s official duties. All participants provided informed consent and this study was approved by the Institutional Review Board for Health Sciences Research at the University of Virginia in compliance with all applicable Federal regulations governing the protection of human subjects. This work was performed in partial fulfillment of the requirement for the doctor of philosophy degree and is archived in the Online Archive of University of Virginia Scholarship (DOI: 10.18130/V3GN1K).

Presented at the Combined Sections Meeting of the American Physical Therapy Association, 23 February 2018, New Orleans, LA and is archived at DOI: 10.7490/f1000research.1115281.1.

Acknowledgements: Rachel Koldenhoven, MEd, ATC and Abbis H. Jaffri, PT, MS for their assistance in performing the clinical examinations. Stephan Bodkin, MEd, ATC for his assistance with allocation. Navy Medicine Professional Development Center and the University of Virginia’s Curry School of Education Foundation for their generosity in providing funding.

Corresponding Author: John J Fraser, Warfighter Performance Department, Naval Health Research Center, 140 Sylvester Road, San Diego, CA 92106 Phone: 757-438-0390 Email: [email protected] ORCID: 0000-0001-9697-3795 Twitter: @NavyPT

Key Words: Ankle Injuries; Recovery of Function; Musculoskeletal Manipulations; Pain Perception; Therapeutics; Treatment Outcome

Title: Effects of midfoot joint mobilization on ankle-foot morphology and function following acute ankle sprain. A crossover clinical trial.

Conflicts of Interest: I affirm that I have no financial affiliation or involvement with any commercial, organization that has a direct financial interest in any matter included in this manuscript.

1

Abstract

2

Background: Midfoot joint impairment is likely following lateral ankle sprain (LAS) that may

3

benefit from mobilization.

4

Objective: To investigate the effects of midfoot joint mobilizations and a one-week home

5

exercise program (HEP) compared to a sham intervention and HEP on pain, patient-reported

6

outcomes (PROs), ankle-foot joint mobility, and neuromotor function in young adults with recent

7

LAS.

8

Methods: All participants were instructed in a stretching, strengthening, and balance HEP and

9

were randomized a priori to receive midfoot joint mobilizations (forefoot supination, cuboid

10

glide and plantar 1st tarsometatarsal) or a sham laying-of-hands. Changes in pain, physical,

11

psychological, and functional PROs, foot morphology, joint mobility, pain-to-palpation,

12

neuromotor function, and dynamic balance were assessed pre-to-post treatment and one-week

13

following. Participants crossed-over following a one-week washout to receive the alternate

14

treatment and were assessed pre-to-post treatment and one-week following. ANOVAs, t-tests,

15

proportions, and 95% confidence intervals (CI) were calculated to assess changes in outcomes.

16

Cohen’s d and 95% CI compared treatment effects at each time-point.

17

Results: Midfoot joint mobilization had greater effects (p<.05) in reducing pain 1-week post

18

(d=0.8), and increasing Single Assessment Numeric Evaluation (immediate: d =0.6) and Global

19

Rating of Change (immediate: d =0.6) compared to a sham treatment and HEP.

20

Conclusion: Midfoot joint mobilizations and HEP yielded greater pain reduction and perceived

21

improvement compared to sham and is recommended in a comprehensive rehabilitation program

22

following LAS.

23

Level of Evidence: II

24 25

Key Words: Ankle Injuries; Recovery of Function; Musculoskeletal Manipulations; Pain

26

Perception; Therapeutics; Treatment Outcome

27 28

Word Count: 3678

29

INTRODUCTION

30 31

Lateral ankle sprains (LAS) are common musculoskeletal injuries incurred by athletes6,46

32

and the general public.49 LAS involve high-velocities and extremes of rearfoot inversion and

33

tibial external rotation32,43 that result in injury of the lateral talocrural18,26 and midfoot1,25,47

34

ligaments. Forty-percent of LAS will progress to chronic ankle instability (CAI),11 a clinical

35

condition described by perceived or episodic ankle giving-way, persistent activity limitation, and

36

participation restriction that persist beyond one-year post injury.10

37

Midfoot injury is common following LAS and may contribute to patient signs and

38

symptoms.13 Of patients who incurred LAS, 21-41% had midfoot ligamentous involvement1,47

39

and 33% had midfoot joint capsular injury.47 Approximately one-quarter of individuals with

40

isolated calcaneocuboid ligament injury were initially diagnosed as having a LAS.1 Midfoot

41

injury may contribute to or mimic LAS symptoms.13 Similar to LAS, persistent pain, swelling,

42

giving-way, and repeat episodes of injury are potential consequences following midfoot injury.47

43

Cuboid Syndrome, a disrupted congruency of the calcaneocuboid joint, is another potential

44

consequence following LAS.5 This syndrome is theorized to result from rearfoot inversion with

45

the forefoot loaded (relative forefoot eversion),5 or an eversion moment of the cuboid during a

46

forceful fibularis longus contraction during LAS.40 Joint mobility assessment of all segments of

47

the ankle-foot complex, especially the midfoot and forefoot, has been recommended for all LAS

48

patients regardless of symptom presentation.13,15

49

In a recent cross-sectional study of ankle-foot morphology and function comparing young

50

adults with and without a history of LAS and CAI, the LAS group with a 2-8 week chronicity

51

demonstrated increased forefoot eversion and tarsometatarsal motion and no differences in total

52

joint excursion compared to healthy controls.15 Diminished forefoot inversion and 1st

53

tarsometarsal plantar joint play measures were also observed.15 These findings were postulated to

54

result from a shift in relative motion further into eversion,15 consistent with the mechanism

55

thought to cause Cuboid Syndrome.5

56

Joint mobilization, stretching, and strengthening exercises have been suggested for

57

patients with midfoot joint impairment.13,15,40 However, evidence for midfoot joint mobilization

58

and exercise following LAS is limited.28,40 Therefore, the purpose of this crossover clinical trial

59

was to investigate the effects of midfoot joint mobilization and a one-week home exercise

60

program (HEP) compared to a sham intervention and HEP on patient-reported and clinical

61

measures in young adults with recent history of LAS.

62 63 64 65

METHODS DESIGN A laboratory-based, crossover clinical trial was performed where the independent

66

variable was treatment (50% allocated to initially receive joint mobilization, 50% allocated to

67

initially receive sham). The primary dependent variables were changes in patient-reported pain

68

and function, foot morphology (foot mobility magnitude, arch height flexibility), joint motion

69

(weight-bearing dorsiflexion, rearfoot goniometry, forefoot inclinometry, 1st metatarsal

70

displacement), strength (handheld dynamometry), and dynamic balance (Star Excursion Balance

71

Test, SEBT) immediately post-treatment and one-week following. Crossover design was selected

72

over a parallel randomized control trial to ensure the individual factors of joint phenotype, injury

73

heterogeneity, and psychological factors4 were accounted for in the design. Controlling these

74

factors superseded the risk of carryover effects or the natural healing that may have occurred

75

during the two-week study period. The trial was registered with the National Institutes of Health

76

(NCT02697461). The study was approved by the university’s Institutional Review Board.

77 78 79

PARTICIPANTS A convenience sample of 17 recreationally-active individuals (8 males, 9 females) aged

80

18-35 with a recent history of LAS were recruited at a public university. Recreationally-active

81

was defined as participation in some form of physical activity for at least 20-minutes per day, at

82

least three times a week. Participants who sustained LAS in the past 2-8 weeks and presented

83

with forefoot-on-rearfoot hypomobility13 were included. Participant demographics and self-

84

report measures are in Table 1. Individuals were excluded if they had a self-reported history of

85

leg or foot fracture, neurological or vestibular impairment that affected balance, diabetes

86

mellitus, lumbosacral radiculopathy, soft tissue disorders such as Marfan or Ehlers-Danlos

87

syndrome, any absolute contraindication to manual therapy, or if they were pregnant.

88

Participants who met inclusion criteria provided informed consent. Figure 1 details the

89

CONSORT39 flow chart from recruitment to analysis.

90

PROCEDURES

91

Baseline Visit

92

Participants provided demographic information, health and injury history, and completed

93

the Foot and Ankle Ability Measure (FAAM) ADL36 and Sport subscales,7 Identification of

94

Functional Ankle Instability (IdFAI),12 the Patient Reported Outcomes Measurement Information

95

System (PROMIS) General Health Questionnaire,22 the 11-item Tampa Scale of Kinesiophobia

96

(TSK-11),50 and the Godin Leisure-time Exercise Questionnaire.17 Height, mass, and leg length

97

were measured. Foot posture was assessed in standing using the Foot Posture Index–6 item

98

version (FPI), a categorical measure of foot type that is based on five observations and one

99

palpatory assessment.44

100

Demographic, medical history, and FPI assessments were performed by a physical

101

therapist and board-certified orthopaedic clinical specialist with 15-years of clinical experience.

102

Physical examinations were performed by either an athletic trainer with three-years clinical

103

experience or a physical therapist with two-years clinical experience who were blinded to

104

participants’ medical history, functional status, and treatment allocation.

105

Morphologic Foot Assessment

106

Morphologic foot measurements were obtained using the Arch Height Index

107

Measurement System (JAKTOOL Corporation, Cranberry, NJ). Total and truncated foot length,

108

arch height, and foot width were measured in sitting and standing. Test-retest reliability for these

109

measures were previously reported by the authors to be excellent.16 Arch height flexibility51 and

110

foot mobility magnitude38 were calculated using the component measurements across loading

111

conditions.

112

Ligamentous Pain-to-Palpation

113

A digital palpatory examination of the anterior talofibular (ATFL), calcaneofibular, and

114

bifurcate ligaments was performed. Participants reported the presence or absence of pain.

115

Joint Motion Measures

116

Weight bearing dorsiflexion (WBDF)3, ankle plantarflexion, inversion, and eversion, and

117

forefoot inversion and eversion joint motion measures16 were performed using previously

118

described methods. WBDF was reported as the linear distance measured from the wall to the toes

119

in centimeters. Joint motion measures of rearfoot plantarflexion, inversion, and eversion were

120

performed using a 30.5-cm plastic goniometer (Merck Corporation, Kenilworth, NJ) and

121

reported in degrees. Forefoot inversion and eversion was measured using a digital inclinometer

122

(Fabrication Enterprises, White Plains, NY) and reported in degrees. Linear excursion of first

123

metatarsal (MT) dorsiflexion and plantarflexion were measured utilizing a custom measuring

124

device consisting of two metal rulers bent to 90° and reported in millimeters.19 Test-retest

125

reliability for these measures were previously reported by the authors to be good to excellent.16,19

126

Muscle Strength

127

Ankle dorsiflexion, plantarflexion, inversion, eversion, and hallux flexion and lesser toe

128

flexion strength were assessed with a handheld dynamometer (Hoggan Health Industries, West

129

Jordan, UT).16 For toe flexion strength measures, the ankle was positioned in 45º plantarflexion

130

to reduce contribution of the extrinsic foot muscles and increase demand of the intrinsic foot

131

muscles.21 Strength measures were based on the highest value of three trials. An estimate of

132

torque was derived from the product of force and segment length, normalized to body mass, and

133

reported in Nmkg-1. Test-retest reliability for these measures were previously reported by the

134

authors to be excellent.16

135

Dynamic Balance

136

Dynamic balance was assessed using the anterior, posteromedial, and posterolateral

137

directions of the Star Excursion Balance Test (SEBT),23 a measure has been found to have

138

excellent test-retest reliability.30 Reach distance was normalized to leg length.20 A composite

139

measurement was calculated from the mean of the three directions.

140

Intervention

141

Following baseline assessment, all participants were instructed in a HEP consisting of

142

triceps surae stretching; four-way stretch of the rearfoot, midfoot, and forefoot; isotonic

143

inversion, eversion and dorsiflexion exercises against resistance tubing; single-limb heel raising;

144

and a single limb balance exercise (Figure 2).14 Participants were asked to perform all exercises

145

three times daily, were provided a handout detailing the exercises, and verbalized understanding

146

following instruction. The decision to utilize a HEP over supervised rehabilitation was to better

147

elucidate the specific treatment effects of the midfoot joint mobilizations.

148

Participants were randomized a priori using a random number generator by the senior

149

author and stratified by sex to receive either the midfoot joint mobilizations or sham intervention

150

on the initial visit. Allocation was performed by an otherwise uninvolved laboratory assistant,

151

concealed in a sealed opaque envelope, and opened by the treating clinician. Participants

152

allocated to receive midfoot mobilizations were provided a dorsolateral cuboid glide with

153

forefoot supination and 1st tarsometatarsal plantar glides.13 Each mobilization technique was an

154

oscillatory Maitland Grade IV applied for 30-seconds duration. If cavitation was not experienced

155

during the first bout of oscillations, a second 30-second bout was provided. Participants allocated

156

to the sham treatment were told that they were to receive a gentle soft-tissue technique similar to

157

massage and were provided a “laying of hands” for 30-seconds using the same hand position and

158

contacts used for the joint mobilizations. Participants rated the change of symptoms using a

159

single assessment numeric evaluation (SANE, -100%=full exacerbation, 0=no change,

160

100%=full resolution) immediately post-intervention and completed the Global Rating of

161

Change (GROC, -7= A very great deal worse, 0= About the same, 7= A very great deal better).

162

Follow-up Visit

163

Participants returned to the laboratory following a one-week washout for reassessment.

164

They completed the PROMIS, Godin, FAAM-ADL and Sport, SANE, and GROC. HEP

165

compliance was assessed by having the participants demonstrate the instructed exercises.

166

Participants were rated by the treating clinician whether or not they could demonstrate the

167

exercises without hesitation and with appropriate technique. Participants rated their compliance

168

using a SANE, with 0% reflective of complete non-compliance with all home exercises and

169

100% representing performance of all exercises three times daily. Any deficiencies in exercise

170

technique were corrected and participants were provided encouragement to continue.

171

Repeat physical examinations were performed pre-and post-intervention. Following the

172

pre-intervention physical examination, participants crossed over to receive the second

173

intervention (i.e. individuals who initially received the sham intervention now received the

174

midfoot joint mobilizations). Participants rated treatment response (SANE) immediately post-

175

intervention and at the end of the visit and completed the GROC.

176

Final Visit

177

Participants returned to the laboratory one-week later for the final reassessment visit

178

consisting of HEP compliance, patient-reported outcomes, and physical examination.

179

STATISTICAL ANALYSIS

180

A priori sample size estimation of 14 participants were needed based on an anticipated 15-

181

point change in the FAAM Sport, an =.05, and =.20.24 Descriptive statistics were calculated for

182

demographic and self-reported measures for each subset of the sample allocated to receive either

183

sham or midfoot mobilization during the first visit. Independent t-tests were used to assess

184

differences between allocation groups.

185

Treatment effectiveness of the two interventions (midfoot joint mobilization, sham) on

186

pain in the past week and pre-and post-intervention patient-reported outcomes measures was

187

compared using dependent t-tests. Proportion estimates and 95% CI were calculated for

188

dichotomous variables. The effects of treatment (midfoot joint mobilization, sham) and time

189

(immediate change, pre-to-1-week change) on clinical measures were assessed using within-

190

subjects repeated measures ANOVAs. Change scores that had a 95% CI that did not cross zero

191

were considered to represent a significant change. Significant changes in outcomes observed

192

immediate post-treatment that were non-significant pre-to-1-week were interpreted as having an

193

immediate, but fleeting effect. Ordinal measures that had greater than five items (GROC) were

194

treated as continuous data during analysis.42,45 Participants were analyzed per allocation using

195

intention to treat.

196

Post hoc Cohen’s d effect size (ES) point estimates and 95% CI8 comparing treatments

197

were calculated for all significant treatment or treatment by time interactions for immediate pre-

198

to-post and 1-week change scores. ES 0-0.19 were interpreted as trivial, 0.2-0.49 small, 0.5-0.79

199

moderate, and >0.8 large.8

200

Data was analyzed using Statistical Package for Social Sciences (SPSS) Version 23.0

201

(IBM, Inc., Armonk, New York) and Microsoft Excel for Mac 2016 (Microsoft Corp., Redmond,

202

WA). The level of significance was p ≤.05 for all analyses.

203 204

RESULTS

205 206

There were no statistical differences in demographics, injury history, foot posture, or

207

patient-reported outcome measures between allocation groups at initial baseline, with the

208

exception of idFAI (Table 1). The group allocated to receive the sham intervention first had

209

significantly greater self-reported instability (IdFAI=26.6±3.5) compared to the joint

210

mobilization first group (IdFAI= 20.7±4.6, p=.009). Objective physical measures were similar

211

between groups prior to treatment. (Tables 3-5). In the assessment of carryover effects between

212

baselines 1 and 2, rearfoot inversion motion was the only measure that had a significant

213

treatment by order interaction.

214

Midfoot inversion and 1st tarsometatarsal plantar hypomobility were present in all

215

participants. Thus, all participants were eligible for random allocation. Joint cavitation was

216

experienced by 35.3% of participants during forefoot mobilization and none during

217

tarsometatarsal mobilization. Between allocation groups, 85.7% of the first mobilization group

218

and 83.3% of the second mobilization group participants received a second 30 second bout of

219

forefoot mobilizations. All participants received a second bout of tarsometatarsal mobilizations.

220

No participants who received the second bout of mobilizations experienced a cavitation in either

221

the midfoot or forefoot.

222

Self-reported compliance with the HEP on initial and final follow-up was 56.3±29.9%

223

and 65.4±21.6% in the initial sham allocation group and 74.5±16.1% and 60.6±31.9% in the

224

initial joint mobilization group, respectively. Seventy-five percent of the sham allocation group

225

was able to appropriately demonstrate the HEP following the first and second weeks. The

226

proportion of the mobilization group able to demonstrate the HEP was 62.5±31.9% during the

227

first week and 87.5±34.6% during the second week.

228

PATIENT-REPORTED OUTCOME MEASURES

229

Between the initial and follow-up visits, there were significant pre to 1-week post

230

improvements reported by both allocation groups in PROMIS physical health composite score,

231

FAAM-ADL (score and SANE), FAAM-Sport (score and SANE), and worst pain in the past

232

week. Only the mobilization treatment had a small, but significant decrease in PROMIS mental

233

health composite score. There were no other significant changes in patient-reported outcomes

234

following the first week of the trial.

235

Between the follow-up to final visits, both allocation groups reported significant

236

improvements in Godin leisure activity, FAAM-ADL score, FAAM-Sport (score and SANE),

237

and worst pain in the past week. Only the sham treatment had improvement in PROMIS physical

238

and mental health composite scores. There were no further changes resulting from either

239

treatment during the second week of the trial.

240

There was significantly greater perceived improvement immediately following joint

241

mobilization as compared to the sham treatment (SANE: p=.04, d=0.6, 95% CI: -0.1, 1.3;

242

GROC: p=.05, d =0.6, 95% CI: -0.1, 1.3) that lasted to 1-week following treatment (SANE:

243

p<.001 GROC: p<.001). A greater reduction in pain was observed following joint mobilizations

244

at 1-week following treatment (p=.004, d =-0.8, 95% CI: -1.5, -0.1). There were no significant

245

differences between treatments for pain at present (p=.10) or worst in the past week (p=.10).

246

Both treatments resulted in a significant decrease in kinesiophobia following the 2-week trial

247

(mean change=-3.1±2.6, p<.001, d=0.8, 95% CI: 0.1, 1.3). While there were no other significant

248

differences between treatments immediate post or 1-week following intervention, group means

249

improved as a result of both treatments resulting in improvements that exceeded minimal

250

clinically important differences in function.36 Table 2 details the comparison of treatment on

251

change in patient-reported outcome measures. Effect size estimates and 95% CI are in Figure 5.

252 253

PHYSICAL OUTCOME MEASURES

254

Pre-intervention descriptive statistics for both allocation groups at Baselines 1 and 2 are

255

in Tables 3-5. Immediate post-intervention and 1-week mean change scores and 95% CI for the

256

joint mobilization and sham treatments are in Figures 3-4. Effect size estimates and 95% CI are

257

in Figure 5.

258 259

Foot Morphology There was a significant increase in arch height flexibility immediate post-mobilization,

260

but not at 1-week post-treatment. There were no further significant changes post-intervention

261

changes immediately or 1-week following and no treatment, time, or treatment by time

262

interactions for foot morphologic composite measures (Table 3).

263

Ligament Pain-to-Palpation

264

There were no statistically significant differences pre-to-post intervention or between

265

treatments for proportion of participants with syndesmotic, bifurcate, anterior talofibular,

266

calcaneofibular, or posterior talofibular pain-to-palpation (Table 3).

267

Joint Motion

268

In the rearfoot, there were significant immediate pre-to-post increases in WBDF and

269

plantarflexion motion, with persistent improvements in WBDF observed at 1-week post-

270

treatment in both groups (Figure 3). In the forefoot, there was a significant increase in forefoot

271

inversion motion and frontal plane excursion motion immediate post sham intervention, but not

272

at 1-week post. First tarsometatarsal excursion significantly increased immediately following

273

joint mobilization (Figure 5). There were no other significant findings for any rearfoot or

274

forefoot joint motion measures (Figure 3-4).

275

Strength and Dynamic Balance

276

A small, but significant decrease in normalized dorsiflexion strength was observed

277

immediately post-intervention for the joint mobilization treatment only. There were no other

278

significant differences for strength measures (Figure 5).

279 280

For dynamic balance measures, there was a significant time effect for improved normalized SEBT composite scores (p<.001), but no other significant findings (Figure 5).

281 282

DISCUSSION

283 284

The principal findings of this crossover clinical trial were that midfoot joint mobilization

285

and a HEP consisting of stretching, strengthening, and balance had greater effects in reducing

286

pain, perceived improvement, and rearfoot, midfoot, and forefoot joint motion as compared to a

287

combined sham treatment and HEP. Regardless of treatment, participants experienced reduction

288

of worst pain in the past week and improvement in self-reported physical activity, function,

289

kinesiophobia, and SEBT performance post-treatment.

290

Both groups had substantial self-reported pain, instability, and activity limitation at

291

baseline that improved with time and treatment. In a unique case-study detailing pre-to-post

292

changes in patient reported outcomes following a LAS, substantial changes in perceived

293

instability, function, and kinesiophobia are observed following injury.14 Due to the abbreviated

294

epoch utilized in the previous case and in the current study, it is unclear if these participants will

295

progress to develop CAI in the long-term.

296

The mechanism of effectiveness of manual therapy is complex and may result in psycho-

297

emotional, neurophysiologic, and mechanical effects.4 Together, these effects may facilitate

298

functional restoration following LAS. For this reason, we opted to collect multidimensional

299

outcome measures to capture potential clinical improvements in body structure and function,

300

activity limitation, and participation restriction that may have resulted from the intervention.

301

Specific effects encompassed in the three domains include pain rating, expectations,

302

psychological measures, and neuromotor response.4 Our findings support that midfoot joint

303

mobilization, when combined with a HEP, may help to improve impairment in these domains

304

and facilitate resumption of activity.

305

Pain reduction was achieved immediately and 1-week following joint mobilization, a

306

finding that can be contextualized using the minimal important differences (MID). Landorf and

307

colleagues33

308

scale. In our study, only the joint mobilization treatment exceeded this MID at 1-week post

309

intervention. Both treatments reduced severity of pain at its worst that exceeded the MID. There

310

was also improved function in the FAAM-ADL and Sport that exceeded minimal detectable

311

change and minimal clinically important differences following the two treatments.36

312

reported that the average MID for foot conditions to be 0.8cm on the VAS pain

We observed positive psychological effects following joint mobilization intervention.

313

Perceived improvement was significantly higher following joint mobilization compared to sham.

314

Psychological traits such as high resiliency and self-efficacy have been suggested to have an

315

important role in injury recovery and return to sport.9,37 While long-term effects of joint

316

mobilization are unclear from our findings, we anticipate that earlier improvements in perceived

317

pain and recovery will create greater optimism and personal investment into treatment that may

318

influence long-term outcomes. Since kinesiophobia is a predictor for disability in patients with

319

foot conditions,34 the significant decrease in this measure following both treatments was a good

320

prognostic indicator for favorable outcomes.

321

A progressive increase in dynamic balance was observed following both treatments.

322

Following LAS, there is peripheral27,41 and central29,31 neurophysiologic consequences following

323

injury. Manual therapy has previously been shown to influence dynamic balance.24 It is unclear

324

from these data if improvements were a result of a neurophysiologic treatment effect, time and

325

healing, or from motor learning when performing a novel task. Ankle dorsiflexion is a covariate

326

with SEBT performance,2 a measure that also increased with time. Lastly, perceived

327

improvement following treatment may influence SEBT measures. Psychological factors, such as

328

previous psychological trauma, have been found be a salient factor in functional movement

329

performance to include the SEBT.48 It is plausible that positive psychological factors resulting

330

from treatment may manifest as improvements in physical performance.

331

CLINICAL RECOMMENDATIONS

332

Midfoot joint mobilizations are recommended, when clinically indicated, as part of a

333

multimodal treatment approach with LAS patients. Patients with midfoot hypomobility or a more

334

inverted rearfoot (with physiologic shift of the forefoot into eversion) may benefit from this

335

treatment.15 Significant clinical improvements were also observed in participants who received

336

the sham treatment and performed exercises that specifically addressed the midfoot and forefoot.

337

While we did not observe ideal compliance with the HEP, participants in both allocation groups

338

performed a substantial volume of exercise and demonstrated improvements with time. Inclusion

339

of stretching and strengthening exercises for the midfoot is recommended.

340

In practice, rehabilitation specialists should not provide treatment using a single

341

intervention approach. Our study design was chosen to evaluate treatment effects of midfoot

342

mobilization without potential confounding introduced by other clinician-provided treatments.

343

The standards of care dictate a comprehensive treatment plan that includes protection, optimal

344

loading, therapeutic exercise, sensorimotor training, and joint mobilization of the rearfoot and

345

shank.35 Coupled with a comprehensive treatment program that addresses rearfoot deficit,

346

midfoot joint mobilization may add value.

347

LIMITATIONS

348

A constraint of the crossover design is the potential for carryover effects. It is also

349

plausible that the order of intervention introduced bias. Participants allocated to receive the

350

mobilization during the second visit may have experienced clinical improvement resulting from

351

performance of the HEP, time, and healing. Similarly, significantly higher baseline

352

kinesiophobia observed in the group allocated to receive the sham treatment first could have

353

potentially mediated treatment outcomes. Comfort may be taken with knowledge that none of

354

our primary outcomes had significant time by order or treatment by order interactions. Also, the

355

decision to use change scores was made a priori to mitigate carryover effects following a one-

356

week washout period. The experimental treatment intervention included only a single session

357

midfoot mobilization and a 1-week HEP. Further research is needed to investigate midfoot

358

mobilization as part of a comprehensive ankle rehabilitation program of longer duration and

359

increased frequency. We utilized recreationally active young adults in our study, which limits the

360

generalizability of our findings to other populations. We included any participant with a recent

361

LAS regardless of number of previous sprains. Participants with both first-time LAS and acute-

362

on-chronic injuries were included. While this may have improved external validity, it is unclear

363

how this affected treatment responsiveness. Since this is the first study to our knowledge to study

364

the effects of a mobilization of the foot following LAS, it possible that the sample size was

365

inadequate to demonstrate significant effects in many of the study outcomes. Replication with a

366

larger sample is warranted. Lastly, we employed a wide range of outcomes to capture potential

367

improvements in clinical and patient-reported measures of physical and psychological

368

impairment, activity limitation, participation restriction, and personal factors that mediate

369

functional outcomes. That, in addition to the multiple potential mechanisms of effectiveness

370

theorized to result from MT,4 warranted investigation. This decision, while deliberate, may have

371

increased risk of a Type I error. While this is a potential outcome when performing multiple

372

comparisons, the authors did not rely on p-values alone and factored ES estimates when forming

373

conclusions.

374 375

CONCLUSION

376 377

Midfoot joint mobilization and a HEP consisting of stretching, strengthening, and

378

balance had greater effects in reducing pain and increasing perceived improvement as compared

379

to a combined sham treatment and HEP. Regardless of treatment, participants had reduced

380

severity of pain in the week previous and improvement in self-reported physical activity,

381

function, kinesiophobia, and SEBT performance. This improvement is likely partly attributed to

382

the effects of the HEP and healing. Midfoot joint mobilizations, stretching, and strengthening

383

exercises are recommended as part of a comprehensive rehabilitation program in LAS patients

384

with midfoot hypomobility or a more inverted rearfoot.

385

386

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List of Tables Table 1. Demographic, injury history, and patient-reported outcome measures in individuals with ankle sprain Table 2. Comparison of treatment on change in patient-reported outcome measures in individuals with ankle sprain Table 3. Comparison of treatment on composite morphologic foot measurement and proportion with ligamentous pain-to-palpation in individuals with ankle sprain Table 4. Comparison of treatment on rearfoot and forefoot joint motion measurements in individuals with ankle sprain Table 5. Comparison of treatment on neuromotor function and dynamic balance in individuals with ankle sprain

538 539

List of Figures

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Figure 1. CONSORT Flow Diagram.

541

Figure 2. Home exercise program. From XXXXXXXXXXXXXXXXXXXXXXXXX.

542

Used with permission of the publisher.

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Figure 3. Rearfoot and forefoot joint motion change measures.

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Figure 4. Strength and dynamic balance change measures.

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Figure 5. Effect size estimates and 95% confidence intervals comparing joint

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mobilization to sham treatment.

Table 1. Demographic, injury history, and patient-reported outcome measures in individuals with ankle sprain Participants Participants allocated Total Sample allocated to receive to receive midfoot sham intervention mobilization first (n=17) 8 males 9 females first (n=8) (n=9) 4 males 4 females 4 males 5 females Mean ± SD p Mean ± SD Age (years) 20.4±1.3 23.2±5.3 .17 21.0±2.3 Height (cm) 170.2±8.8 174.1±9.5 .39 172.3±2.2 Weight (kg) 67.1±13.5 75.7±10.6 .17 71.6±12.5 2 BMI (kg/m ) 23.1±3.4 25.0±3.9 .29 24.1±3.7 Foot Posture Index 2.0±3.6 3.0±3.2 .56 2.5±3.4 Ankle sprains (n) 2.5±1.4 3.2±3.0 .54 2.9±2.3 Time to injury (months) 0.9±0.5 0.9±0.7 .84 0.9±0.6 IdFAI 26.6±3.5 20.7±4.6 .009 23.9±4.7 Kinesiophobia (TSK-11) 23.9±4.7 20.4±4.3 .14 22.1±4.7 cm=centimeters, kg=kilograms, BMI=body mass index, IdFAI=Identification of Functional Ankle Instability, TSK=Tampa Scale Kinesiophobia

Table 2. Comparison of treatment on change in patient-reported outcome measures in individuals with ankle sprain Pre-to-Post Pre-to-Post Baseline 2 Change Change Mean±SD p Pain VAS (cm) IMM:0.3±1.8 IMM:0.4±0.6 Sham 1.4±1.5* 0.9±1.0† .10‡ At Present 1wk: -0.2±1.3 1wk: 0.4±0.6 .004§ IMM:-0.6±1.3 IMM:0.2±0.7 .08|| Treatment 2.0±2.1† 1.2±1.7* 1wk: -1.1±1.4 1wk: -0.8±1.7 Sham 3.5±1.9* -1.9±1.7 1.8±1.1† -0.7±1.3 Worst in the Past Week .10 † * Treatment 3.3±1.8 -1.6±1.6 1.6±1.8 -0.9±1.6 PROMIS General Health (t) Sham 49.2±5.8* 2.9±5.5 55.6±3.9† 2.4±6.7 .87 † * Physical Composite Treatment 52.0±6.8 2.4±6.7 52.0±6.0 1.8±5.9 Sham 55.9±7.0* 1.3±5.2 61.7±4.5† 3.1±2.1 Mental Composite .28 † Treatment 62.1±8.3 -2.8±3.0 57.1±11.0* 1.9±7.5 Sham 47.1±27.2* 3.5±13.5 84.3±101.4† 9.8±19.5 Godin Leisure Time Activity .32 † Treatment 42.8±24.7 39.5±92.7 50.6±19.0* 7.1±13.4 FAAM (%) Sham 74.0±17.1* 12.3±16.1 92.6±4.0† 2.0±3.9 .81 † ADL Score Treatment 78.7±13.3 12.0±10.5 86.3±9.4* 4.4±4.8 * † Sham 46.9±27.7 19.9±22.0 70.5±18.7 13.1±16.0 Sport Score .88 Treatment 46.6±31.4† 22.9±21.3 66.8±20.3* 10.8±11.3 IMM:4.0±12.7* IMM:10.0±31.3† Sham .04‡ 1wk: 35.7±34.1* 1wk: 65.0±29.8† Perceived Improvement <.001§ SANE (%) IMM:36.2±42.5† IMM:21.4±21.7* .27|| Treatment 1wk: 56.9±33.1† 1wk: 56.9±37.0* IMM:.63±2.0† IMM:-0.1±1.4* Sham .05‡ * 1wk: 2.0±1.9 1wk: 4.1±1.7† Global Rating of Change <.001§ IMM 2.4±2.6† IMM:1.4±2.3* .19|| Treatment 1wk: 3.1±2.0† 1wk: 3.9±2.4* IMM=Immediate pre-to-post change, 1wk=Pre-to-1-week post change, VAS = visual analogue scale, PROMIS=Patient Reported Outcome Measures Information System, FAAM=Foot and Ankle Ability Measure, ADL=activities of daily living, SANE=single assessment numeric evaluation *Received sham intervention first, †Received midfoot joint mobilization first ‡ Treatment Main Effect, § Time Main Effect, || Treatment by Time Interaction Baseline 1

Table 3. Comparison of treatment on composite morphologic foot measurement and proportion with ligamentous pain-to-palpation in individuals with ankle sprain Baseline 1 Baseline 2 Pre-to-Post Change p Composite Foot Measures (95% CI) Mean±SD IMM:0.0 (-0.3, 0.3) Sham 1.3±0.8* 1.5±0.8† Arch Height 26‡ 1-wk: 0.0 (-0.2, 0.2) Flexibility .88§ IMM:0.3 (0.1, 0.5) -1 (cm kg ) Treatment .91|| 1.2±0.4† 2.4±1.0* 1-wk: 0.2 (-0.1, 0.5) IMM:0.4 (-0.3, 1.1) * † Sham 1.9±1.5 3.5±3.0 .70‡ 1-wk: 0.2 (-0.7, 2.1) Foot Mobility .73§ Magnitude (cm) IMM:-0.2 (-0.6, 1.0) † * .60|| Treatment 3.4±1.7 3.4±0.7 1-wk: 0.2 (-0.8, 1.2) Proportion Pre-to-Post Change Ligamentous Pain-to-Palpation (95% CI) (95% CI) * † Anterior talofibular Sham 50.0 (21.5, 78.5) 25.0 (7.1, 59.1) -17.7 (-44.1, 12.0) ligament (%) Treatment 22.2 (6.3, 54.7) † 12.5 (2.2, 47.1) * 7.7 (-21.4, 35.8) Calcaneofibular Sham 12.5 (2.2, 47.1) * 12.5 (2.2, 47.1) † -5.8 (-30.0, 19.0) Treatment 33.3 (12.1, 64.6) † 12.5 (2.2, 47.1) * -11.0 (-36.4, 16.3) ligament (%) * † -6.2 (-31.4, 20.0) Sham 12.5 (2.2, 47.1) 12.5 (2.2, 47.1) Bifurcate ligament † * (%) -4.3 (-29.6, 22.8) Treatment 22.2 (6.3, 54.7) 0.0 (0.0, 32.4) cm=centimeters, kg=kilograms, IMM=immediate, wk=week *Received sham intervention first, †Received midfoot joint mobilization first ‡ Treatment Main Effect, § Time Main Effect, || Treatment by Time Interaction

Table 4. Comparison of treatment on rearfoot and forefoot joint motion measurements in individuals with ankle sprain Baseline 1 Baseline 2 Rearfoot Mean±SD Weight-bearing Sham 9.8±3.2 * 9.7±2.6† † Dorsiflexion (cm) Treatment 12.0±7.8 11.0±3.0 * Sham 67.5±9.7 * 58.9±8.4† † Plantarflexion (º) Treatment 60.8±6.5 66.9±10.1 * Sham 31.3±9.2 * 35.4±9.5† Inversion (º) † Treatment 34.0±7.8 30.4±8.7 * Sham 11.1±5.4 * 12.6±4.1† Eversion (º) † Treatment 13.9±5.6 10.8±4.8 * Forefoot Inversion (º) Eversion (º) 1st Metatarsal Dorsiflexion (mm)

Sham Treatment Sham Treatment

32.9±7.9 * 36.2±9.8 † 17.7±5.2 * 20.5±9.5 †

42.8±7.8 † 32.8±7.3 * 18.0±6.9 † 16.5±4.6 *

Sham 5.3±1.5 * 5.8±1.1 † † Treatment 5.7±1.9 5.0±1.6 * Plantarflexion (mm) Sham 6.8±2.1 * 7.7±1.3 † † Treatment 8.0±1.4 6.9±1.8 * *Received sham intervention first, †Received midfoot joint mobilization first

Table 5. Comparison of treatment on neuromotor function and dynamic balance in individuals with ankle sprain Baseline 1 -1

Strength (normalized, Nm kg ) Ankle Dorsiflexion Ankle Plantarflexion Ankle Inversion Ankle Eversion Hallux Flexion Lesser Toe Flexion

Baseline 2

Mean±SD Sham Treatment Sham Treatment Sham Treatment Sham Treatment Sham Treatment Sham Treatment

*

3.1±0.8 3.2±0.9 † 5.2±1.4 * 5.5±2.8 † 2.3±0.6 * 2.0±0.6 † 2.2±0.6 * 2.2±0.6 † 0.9±0.2 * 0.6±0.2 † 0.8±0.2 * 0.6±0.2 †

3.1±1.4 † 3.2±0.7 * 5.2±3.6 † 5.6±1.5 * 1.9±1.0 † 2.5±0.6 * 2.1±1.1 † 2.3±0.6 * 0.6±0.3 † 1.0±0.2* 0.6±0.3 † 0.9±0.1 *

Dynamic Balance (normalized, %) Sham 68.9±5.2 * 73.8±3.9 † † Treatment 70.4±5.0 77.0±4.6 * SEBT = Star Excursion Balance Test *Received sham intervention first, †Received midfoot joint mobilization first Composite SEBT

Highlights • • •

A trial was performed assessing midfoot joint mobilization after ankle sprain vs. sham Midfoot joint mobilizations yielded greater pain reduction and perceived improvement Midfoot joint mobilizations are recommended with exercises following ankle sprain.