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Predictors of Response to Physical Therapy Intervention for
Plantar Heel Pain: A Secondary Analysis of Data from a
Randomized Clinical Trial.
Journal: Foot & Ankle International
Manuscript ID: FAI-14-0438.R2
Manuscript Type: (Original) Clinical Research Article
Keywords: Exercise, Manual Therapy, Obese, Plantar Fasciitis, Prognosis
STRUCTURED ABSTRACT (Limit 250 words) <br>
Background:
Background: Age, weight, and duration of symptoms have been associated
with a poor response to treatment for plantar heel pain (PHP), but have not been examined in response to physical therapy (PT) intervention. The purpose of this investigation was to examine the influence of age, body mass index (BMI), and symptom duration on treatment response to PT intervention. Methods: Sixty participants received 6 sessions of PT intervention over 4 weeks that included manual therapy and exercise or electrophysiological agents and exercise. Outcomes were assessed at 6 months using the Foot and Ankle Ability Measure (FAAM), Numeric Pain Rating Scale (NPRS), and Global Rating of Change Scale (GRC). Logistic regression was used to analyze age, BMI, and symptom duration as predictors of a successful response based on minimal clinically important changes in the FAAM, NPRS
and GRC, or only the FAAM and NPRS. Results: Improvement in NPRS was 3 points (95% CI; 2.4, 3.6) and FAAM improved by 22.5 points (95% CI; 16.8, 28.2). Individuals with symptoms less than 7.2 months were 4.2 (95% CI; 1.3, 13.8; p=.016) and 8.5 (95% CI; 2.5, 28.9; p=.001) times more likely to respond based on the NPRS/FAAM/GRC, and NPRS/FAAM success criteria, respectively. Age and BMI were not significant predictors. Conclusion: Body mass was not associated with outcomes and obese individuals can achieve clinical success with the PT intervention used in the clinical trial. Individuals with PHP symptoms longer than 7 months require additional consideration and further investigation of effective strategies to improve treatment response.
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Predictors of Response to Physical Therapy Intervention for Plantar Heel 1
Pain: A Secondary Analysis of Data from a Randomized Clinical Trial. 2
3
4
Abstract 5
Background: Age, weight, and duration of symptoms have been associated with 6
a poor response to treatment for plantar heel pain (PHP), but no studies were 7
identified that examined predictors of response to physical therapy intervention. 8
The purpose of this investigation was to examine the influence of age, body 9
mass index (BMI), and symptom duration on treatment response to physical 10
therapy intervention. 11
Methods: Sixty participants received 6 visits over 4 weeks of physical therapy 12
intervention that included manual therapy and exercise or electrophysiological 13
agents and exercise. Outcomes were assessed using the Foot and Ankle Ability 14
Measure (FAAM), Numeric Pain Rating Scale (NPRS), and Global Rating of 15
Change Scale (GRC). Logistic regression (p<.05) was used to analyze age, BMI, 16
and symptom duration as potential predictors of a successful response based on 17
the minimal clinically important difference of the outcome measures. Sensitivity 18
analysis was used to assess the influence of success based on minimal clinically 19
important changes in the FAAM, NPRS and GRC, or only the FAAM and NPRS. 20
Receiver operating curves were used to determine the cut point for the significant 21
predictor. 22
Results: At the 6 month follow-up to physical therapy intervention, NPRS was 23
improved by 3 points (95% CI; 2.4, 3.6) and FAAM improved by 22.5 points (95% 24
CI; 16.8, 28.2). Individuals with symptoms less than 7.2 months were 4.2 (95% 25
CI; 1.3, 13.8; p=.016) and 8.5 (95% CI; 2.5, 28.9; p=.001) times more likely to 26
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respond to treatment based on the NPRS/FAAM/GRC, and NPRS/FAAM 27
success criteria, respectively. Age and BMI were not significant predictors (p ≥ 28
.455 and p ≥ .450, respectively). 29
Conclusion: Age and BMI were not associated with outcomes and obese 30
individuals did achieve a successful outcome with the physical therapy 31
intervention used in the clinical trial. Individuals with PHP symptoms longer than 32
7 months require additional consideration and further investigation of effective 33
strategies to improve treatment response. 34
Level of Evidence: Prognosis, level 2b 35
36
Key Words: Plantar Fasciitis, Prognosis, Obese, Manual Therapy, Exercise. 37
38
39
Introduction 40
41
Plantar heel pain (PHP), commonly referred to as plantar fasciitis, is a 42
frequently occurring foot condition that results in disability and limited function in 43
work, recreation, and daily activities. While plantar fasciitis has been reported as 44
the most common cause of plantar heel pain, the term plantar heel pain is 45
inclusive of other pathological and painful conditions of the plantar fascia and 46
heel that are often difficult to discriminate via history and physical examination.6, 47
68 Individuals with PHP incur approximately 800,000 to 1 million visits to 48
physicians annually at an estimated cost of 192 to 376 million US dollars.55, 62 In 49
addition to physician visits, PHP was the most prevalent condition treated by 50
podiatrists and the most common foot condition seen by physical therapists.2, 52 51
Conservative (ie, non-surgical and non-extracorporeal shock wave therapy) 52
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interventions are advocated initially to manage PHP and most patients respond 53
positively to treatment.13, 42, 48, 61 Despite improvement in most who are treated 54
conservatively for PHP, approximately 18-50% of individuals continue to have 55
symptoms after conservative treatment and 30% have recurrent symptoms.5, 15, 56
39, 67 57
Incomplete recovery or failure to respond to conservative treatment may 58
be attributed to patient characteristics that affect treatment response. Age, body 59
mass, and duration of symptoms have been identified as characteristics 60
associated with a reduced response to conservative treatment for plantar heel 61
pain (PHP).21, 30, 39, 51, 67 Recently, a randomized clinical trial demonstrated 62
clinically meaningful improvement following multi-modal physical therapy 63
intervention for PHP,8 but did not analyze the influence of age, body mass, or 64
duration of symptoms on treatment response. No other evidence was found to 65
indicate factors associated with treatment response to multi-modal physical 66
therapy intervention. Knowledge of factors that can potentially affect outcome 67
can help identify individuals less likely to respond to physical therapy 68
intervention. Once identified, additional research can focus on strategies that 69
may be more effective for subgroups of nonresponders and help to reduce the 70
incidence of persistent or recurrent symptoms in individuals with PHP. Therefore, 71
the purpose of this investigation was to identify if age, body mass, or symptom 72
duration were predictors of outcome to physical therapy intervention in 73
individuals with PHP. 74
75
76
Materials and Methods 77
78
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Participants 79
The study population included 60 individuals who participated in a 80
randomized clinical trial between October 2006 and January 2008.8 Participants 81
included patients with PHP between the ages of 27 and 63 years that presented 82
to physical therapy at 1 of 2 outpatient orthopaedic physical therapy clinics. The 83
diagnosis of PHP was based on pain locatedalized to at the medical calcaneal 84
tubercle and pain worstened withduring the first few steps in the moringafter 85
waking. clinical presentation without additional iImaging was not used to further 86
discriminate the pathological conditions associated with the clinical presentation 87
of PHP.studies. Patients with precautions to manual therapy interventions (ie, 88
tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged history of steroid 89
use, severe vascular disease, etc), prior surgery to the distal tibia, fibula, ankle 90
joint, or rearfoot region (proximal to the base of the metatarsals), insufficient 91
English proficiency to complete questionnaires, or inability to comply with 92
treatment and follow-up schedules were excluded. Prior to participating in the 93
clinical trial, patients reviewed and signed a consent form approved by The 94
Human Investigations Committee, XXXXXX and the XXXXXX prior to 95
participation in the clinical trial.8 96
97
Measures 98
All participants in the clinical trial completed a standardized baseline 99
examination at the outset that recorded age, sex, duration of symptoms, body 100
mass index (BMI), and use of medications. In addition, the activities of daily living 101
subscale of the Foot and Ankle Ability Measure (FAAM), the Lower Extremity 102
Functional Scale (LEFS), the Beck Anxiety Index (BAI), and the 3-item (current, 103
best, worst pain) Numeric Pain Rating Scale (NPRS) were completed at 104
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baseline, 4 weeks, and 6 months after initiation of treatment. Also, the Global 105
Rating of Change Scale (GRC) was completed at 4 weeks and 6 months after 106
baseline. For the purpose of this secondary analysis, the variables selected 107
included age, duration of symptoms, BMI, FAAM, NPRS, and GRC. The FAAM 108
consists of 21 questions about the difficulty (range; 0 = unable to do, through 4 = 109
no difficulty) of daily tasks due to foot and ankle problems. The total score is 110
divided by the highest possible score and multiplied by 100, where 0 = no 111
functional ability and 100 = highest state of functional ability. The FAAM has 112
demonstrated content and context validity, an intraclass correlation coefficient 113
(ICC) of 0.89, and a minimal clinically important difference (MCID) of 8 points.38 114
An 11-point NPRS, where 0 = no pain and 10 = worst imaginable pain was used 115
to capture pain intensity. The NPRS with 3-items has demonstrated validity, a 116
test-retest reliability of 0.61 to 0.88 and a MCID of 2 points.7, 18, 31, 32 The GRC is 117
a single item questionnaire that ranks patient-perceived improvement between -7 118
(a very great deal worse) to 0 (about the same) to +7 (a very great deal better).29 119
Scores of +5 (quite a bit better) have been used as an indicator of clinical 120
success.9, 29, 35 121
122
Procedures 123
Complete details of the clinical trial procedures are described by Cleland 124
et al.8 Participants received 6 visits over 4 weeks of physical therapy intervention 125
that included manual therapy and exercise or electrophysiological agents and 126
exercise. Both groups received exercises that included stretching and self-127
mobilization of the plantar fascia, calf stretching with the knee flexed and 128
extended, and ankle eversion self-mobilization. All patients were instructed to 129
perform all activities of daily living that did not increase symptoms and to avoid 130
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aggravating activities. In the group that received manual therapy, intervention 131
was based upon patient-specific impairments in the hip, knee, lower leg, ankle, 132
and foot regions. Manual therapy included joint mobilization or manipulation to 133
the aforementioned areas and soft tissue mobilization to the plantar fascia and 134
flexor hallicus longus. In the group that received electrophysiological agents, 135
ultrasound (3 MHz, 1.5 W/cm2, 100-Hz, 20% duty cycle, 5 minute duration) was 136
performed to the involved area followed by iontophoresis with dexamethasone 137
(40 mA·min dose). Thirteen patients were taking anti-inflammatory medication at 138
the start of the study and were instructed to continue usage as prescribed by 139
their physician. Patients were limited to intervention provided within the clinical 140
trial and did not receive any other intervention; eg, injections, night splints, anti-141
inflammatory medication (other than that taken prior to outset of the study), or 142
immobilization were not utilized. Both groups were collapsed into one to 143
determine response to physical therapy intervention that included exercise and 144
modalities or exercise and manual therapy. The FAAM, LEFS, BAI, NPRS, and 145
GRC were administered at 4 weeks and 6 months after the start of treatment. 146
147
Statistical Analysis 148
All data analyses and imputations were performed using SPSS, Version 149
22.0 (SPSS Inc., Chicago, IL, USA). Despite significant difference in outcomes 150
between the 2 physical therapy intervention groups, significant, and clinically 151
meaningful, improvement was observed in both groups.8 Therefore, to provide 152
the most comprehensive analysis that included all responders to physical therapy 153
intervention, participants from both treatment groups were included in the 154
analysis consistent with multivariate prognostic modelling recommendations and 155
procedures used by other responder analyses of randomized clinical trials.20, 24, 156
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25, 33, 46 This type of analysis allows a detailed analysis of whether age, body 157
mass, or symptom duration should alter the decision to manage PHP with 158
physical therapy interventions. Less than 12% of the original data was missing 159
for the variables used in this investigation. Multiple imputation procedures were 160
used to handle missing values after analysis of the missing data and observed 161
absence of monotonicity. Five imputed data sets were generated using the 162
Markov Chain Monte Carlo method and pooled estimates from the multiple 163
imputations were used when reporting data. Patient characteristics and outcome 164
variables were summarized using the mean and standard deviation for 165
continuous measures and the frequency and percentages for categorical 166
measures (Table 1). 167
Standard logistic regression (p < .05) was used to analyze age, BMI, and 168
symptom duration as predictors of successful treatment response based on the 169
minimal clinically important difference (MCID) of the outcome measures. 170
Predictor variables were tested for multicollinearity and demonstrated variance 171
inflation factor values greater than 10 and tolerance values less than 0.10 in all 172
imputed data sets. A sensitivity analysis was conducted using 2 criteria to define 173
successful response to physical therapy intervention. In the first scenario, 174
participants were defined as having a successful response if they exceeded 175
MCID thresholds for 3 outcome measures (NPRS, 2 points; FAAM, 8 points; and 176
GRC, +5 or greater) at the 6 month follow-up similar to procedures used by 177
Cleland et al.10 In the second scenario, successful response was defined only 178
using the MCID of the NPRS and FAAM. Recent evidence has demonstrated 179
concerns regarding the validity and stability of the GRC and therefore both 180
analyses were conducted to assess the influence of a successful response 181
criterion that does not include the GRC.22, 57 Receiver operating curves were 182
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used to determine the cut point for the significant predictor and the Nagelkerke 183
R2 was used to describe the amount of variation explained by the significant 184
predictor. The odds ratio (95% CI) was reported to indicate the odds of a 185
successful response to treatment based on the determined cut point of the 186
significant predictor. Sensitivity, specificity, and positive and negative likelihood 187
ratio values were calculated for the predictor variable. In addition, MANCOVA 188
and Chi-square tests were used to compare the FAAM, NPRS, and GRC 189
between individuals above and below the cut point for the significant predictor 190
using baseline scores as the covariate. 191
Separate post hoc power analyses for logistic regression analyses were 192
performed using G*Power 3.1.6 using the observed odds ratio, Pr (y = 1 | x = 1) 193
H0 calculated from classification tables and R2 obtained from both response 194
criteria analyses, and α = .05.19 195
196
197
Results 198
199
The characteristics of the sample included middle-aged participants who 200
were, on average, obese (Table 1).45 Mean changes in NPRS and FAAM scores 201
in response to physical therapy intervention at the 6 month follow-up exceeded 202
the MCID of 2 and 8 points, respectively (Table 1). Also, the lower confidence 203
interval of the FAAM and NPRS change score exceeded the MCID. In addition, 204
67% of participants reported a GRC of +5 (quite a bit better) or greater. 205
The sensitivity analysis demonstrated different frequencies of successful 206
response between the 2 criteria used. The NPRS/FAAM/GRC criteria resulted in 207
29 cases deemed a successful response and the NPRS/FAAM criteria defined a 208
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successful response in 38 cases (Table 1). Duration of symptoms was the only 209
significant predictor in logistic regression analyses using the NPRS/FAAM/GRC 210
and the NPRS/FAAM criteria. Age and BMI were not significant predictors (p ≥ 211
.455 and p ≥ .450, respectively) of successful treatment response. Analysis of the 212
receiver operating curves for symptom duration identified a cut-point of 218 days 213
(ie, 7.2 months) for both successful response criteria. Individuals with symptoms 214
less than 7.2 months were 4.2 (p = .016) and 8.5 (p = .001) times more likely to 215
respond to treatment based on the NPRS/FAAM/GRC, and NPRS/FAAM 216
success criteria, respectively (Table 2). Sensitivity, specificity, and positive and 217
negative likelihood ratio values for the accuracy of symptoms less than 7.2 218
months to predict a positive response to physical therapy intervention are listed 219
in Table 2. Using the response rate of the sample and calculated likelihood ratios 220
(Tables 1 and 2), the probability of successful response to physical therapy 221
intervention if symptoms were present less than 7.2 months increased from 48% 222
to 68% (95% CI 52, 81) using the NPRS/FAAM/GRC criteria and from 63% to 223
83% (95% CI 70, 91) using the NPRS/FAAM criteria. Differences in the FAAM, 224
NPRS, and GRC between individuals with symptoms less than, and greater than, 225
7.2 months are provided in Table 3. 226
For the logistic regression analysis using the NPRS/FAAM/GRC criteria, 227
the Nagelkerke R2 ranged from 0.117 to 0.181 in the 5 imputed data sets and 228
indicated that duration of symptoms predicted 18.1% of the variation, at best. The 229
Nagelkerke R2 using the NPRS/FAAM criteria range between 0.258 to 0.326 and 230
therefore duration of symptoms explained 32.6% of the variation, at best. 231
Results of post-hoc power analysis indicated a power of 0.97 for the 232
analysis including the NPRS/FAAM/GRC criteria and a power of 0.99 using the 233
NPRS/FAAM criteria. 234
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235
236
Discussion 237
In the clinical trial, 48% to 63% of individuals with PHP demonstrated a 238
successful response to 6 sessions of multi-modal physical therapy intervention 239
conducted over 4 weeks. If PHP symptoms were present for less than 7.2 240
months, the probability of a successful response increased to 68% and 83% for 241
the NPRS/FAAM/GRC and NPRS/FAAM criteria, respectively. There were no 242
other investigations found that examined success to intervention for PHP based 243
upon the 2 criteria used in this investigation. The criteria and rate of success to 244
conservative intervention for PHP varies widely between studies making direct 245
comparison difficult. Some investigations have reported success rates ranging 246
from 44% to 89% based upon patient reports of improvement of symptoms, no 247
pain, total/100% relief, resolution of symptoms, good to excellent results, or 80% 248
relief of symptoms.4, 14, 21, 39, 44, 47, 56, 59, 67 Other investigations have used outcome 249
instruments to define success that included an 11-point visual analog scale 250
(VAS) less than 5, GRC greater than +4, GRC greater than +5, or FAAM change 251
greater than 8 points and have reported success rates ranging from 45% to 252
80%.16, 35, 37 When looking at the success rates of individual measures from the 253
clinical trial (Table 1), rates of success were similar to other investigations that 254
demonstrated 80% success based on FAAM change greater than or equal to 8 255
and 70% success based on GRC greater than or equal to +5.16, 35 256
While no responder criteria was found to determine the cut point for 257
successful response in individuals with PHP, responder criteria based on multiple 258
measurement domains including pain, function, and patient’s global rating of 259
change has been developed and used in other populations.10, 49, 50 The 260
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successful response criteria used in this investigation was chosen to minimize 261
the possibility of deeming a response successful based on only 1 domain of 262
response to treatment where unsuccessful responses may still be observed in 263
other domains. As a result, the success rates observed in this investigation may 264
be lower than investigations using only 1 measure to determine success. In 265
addition to using criteria involving 3 measures of response to treatment, a parallel 266
analysis was conducted only using the NPRS and FAAM criteria. While the 267
NPRS/FAAM/GRC and NPRS/FAAM criteria produced similar results in logistic 268
regression analysis, the NPRS/FAAM analysis resulted in an increased success 269
rate and a higher odds ratio associated with the predictor variable. The increased 270
success rate and odds ratio is likely attributed to the lower standards to achieve 271
success in the NPRS/FAAM criteria; ie, 2 versus 3 measures used as the cut 272
point for successful response. Despite evidence that the GRC lacked correlation 273
with functional change measures, GRC may represent an important treatment 274
response construct worthy of consideration when determining treatment 275
success.22, 57 In this study, a more conservative estimate of successful response 276
to treatment was obtained when the GRC was added to the pain and function 277
measures compared to the pain and function measures alone. Further 278
consensus is needed to improve consistency in reporting of response to PHP 279
conservative treatment so that better comparisons can be made between 280
investigations. 281
A successful response to physical therapy intervention was found in this 282
analysis despite a sample that included individuals who, on average, were obese 283
(Table 1).45 Furthermore, high BMI was not a predictor of poor response to 284
treatment in the logistic regression analysis. Previously, increased weight or 285
obesity had been associated with an increased risk of PHP.23, 27, 28, 54 In addition, 286
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individuals who are overweight or obese were reportedly less responsive to 287
conservative treatment for PHP.21, 30, 67 Because PHP often limits weight-bearing 288
exercise, individuals with PHP are less able to use exercise to manage their 289
weight.48 The results of this analysis are promising in that individuals who are 290
overweight or obese can have a successful response to physical therapy 291
intervention for PHP allowing them to reap the benefits of weight-bearing 292
exercise. 293
Increased age is another factor that has been associated with PHP and 294
decreased response to conservative treatment.27, 51 In this analysis, age was not 295
a significant factor that predicted successful response to treatment, but this 296
sample was limited to individuals between the ages of 27 – 63. Because of the 297
limited age range of this sample, it is unclear if individuals greater than 63 years 298
of age have a different rate of success than individuals less than 63 years old. 299
Approximately 15% of individuals with PHP are greater 65 years or older and 300
therefore it is important to identify successful interventions for PHP in older 301
adults.55 302
The results of this analysis indicated that individuals with PHP symptom 303
duration less than 7 months were more likely to respond to the physical therapy 304
intervention included in the clinical trial. Two other studies were found that 305
reported a reduced response to conservative intervention for PHP if symptoms 306
were present for a longer duration; ie, 12 or more months.39, 67 In a telephone 307
survey of 100 patients treated conservatively by 3 orthopaedic surgeons, a good 308
result (defined as no symptoms) was achieved in 14/22 (64%) with symptoms for 309
12 or more months compared to 68/78 (87%) with symptoms less than 12 310
months (p < .003).67 Conservative treatment was case-specific and included 311
stretching, cushion or hard shoe inserts, anti-inflammatory medication or 312
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injections, ice or heat, heel cup, night splint, or foot strapping. Similarly, in a 313
mailed follow-up survey to 157 PHP patients that received conservative 314
treatment from one orthopaedic surgeon, patients with symptoms greater than 12 315
months were less likely to have a good outcome defined as no pain (p < .04).39 316
Conservative treatment included anti-inflammatory medication or injection, night 317
splint, at least one session of exercise instruction provided by a physical 318
therapist, and a custom orthosis or heel cup. In the clinical trial that provided the 319
sample for this analysis, patients received physical therapy intervention that 320
included stretching and self mobilization exercises to the lower leg, ankle, and 321
foot in addition to manual therapy or electrophysiological modalities. Despite the 322
different conservative treatments provided to the participants that formed the 323
sample for this analysis and in other studies that demonstrated reduced 324
response with longer symptom duration, symptom duration appears to be a 325
significant prognostic factor to consider in the conservative management of 326
individuals with PHP. 327
Individuals with longer symptom duration may develop different pain 328
mechanisms that contribute to their PHP experience and response to treatment. 329
Individuals with a longer duration of pain demonstrated maladaptive psychosocial 330
factors consistent with a central sensitization versus nociceptive pain 331
mechanism.60 The reduced treatment response associated with longer duration 332
of PHP symptoms and evidence of lower foot function in PHP patients with 333
higher stress and depression indicates the potential for central sensitization 334
mechanisms in patients with a longer duration of PHP.12 Therefore, clinical 335
reasoning models that integrate intervention with consideration of pain 336
mechanism and clinical presentation may benefit individuals with longer PHP 337
symptoms. Therapeutic pain neuroscience education is one intervention that is 338
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recommended in the presence of central sensitization and has demonstrated 339
positive effects on pain, disability, anxiety and stress in chronic musculoskeletal 340
pain conditions.36 No evidence was found on the effects of therapeutic pain 341
neuroscience education in individuals with PHP although a clinical trial is 342
underway that includes this as one part of the conservative management plan.40 343
In addition to therapeutic pain neuroscience education, other interventions 344
directed at proximal inputs to PHP through central or peripheral neurodynamic 345
mechanisms; eg, myofasicial trigger points, may be of additional benefit. 346
Myofascial trigger point manual and dry needling intervention has demonstrated 347
significant improvement of PHP, pain pressure thresholds, and foot-related 348
function.1, 11, 53 In investigations of myofascial trigger point therapy on PHP, only 349
Cotchett et al11 included a sample of participants with an average duration 350
greater than 7 months. Further research is needed to identify factors related to 351
longer duration of PHP and to test the effects of pain neuroscience education 352
and myofascial trigger point intervention on chronic PHP. 353
The results of this analysis indicated that symptom duration was a 354
significant predictor of response to physical therapy intervention for PHP. While, 355
the results of this analysis provide evidence of an improved response with a 356
shorter duration of symptoms and a lesser response with a longer duration of 357
symptoms, caution is warranted in generalizing the results. As indicated in Table 358
3, individuals with symptoms longer than 7 months had higher functional scores 359
on the FAAM and lower pain on the NPRS at baseline that may have limited 360
potential for improvement. Conversely, individuals with a lower duration of 361
symptoms had lower functional scores and higher pain scores at baseline which 362
may have contributed to greater potential for improvement. Therefore, because 363
the responder criteria were based on the magnitude of response; ie, the MCID of 364
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outcome measures, the effect of duration determined from logistic regression 365
may have been affected by the baseline differences between individuals above 366
and below the 7 month duration cut point. Despite the statistical significance that 367
demonstrated greater odds of successful outcome in individuals with symptoms 368
less than 7 months, clinically meaningful changes were also observed in 369
individuals with symptoms greater than 7 months based on the MCID of the 370
NPRS and FAAM (Table 3). In addition, an equal proportion of individuals with 371
symptoms greater and less than 7 months demonstrated GRC of +5 or greater 372
(Table 3). While further research is warranted to examine effective solutions in 373
individuals with a longer duration of symptoms, the physical therapy intervention 374
provided in this clinical trial resulted in clinically-meaningful changes regardless 375
of symptom duration and was still effective in individuals with symptoms greater 376
than 7 months. 377
In addition to duration of symptoms, there may be other factors that were 378
not recorded during the clinical trial or considered in this analysis that may 379
predict successful treatment response. Symptom duration explained 11.7 to 380
32.6% of the variation in the data, and therefore other factors are likely to 381
contribute to the remaining variability in treatment response. Few studies were 382
found that investigated factors related to response to conservative treatment 383
other than age, BMI, and symptom duration. Several other factors derived from 384
the history and physical examination including foot posture/mobility, ankle or 385
hallux dorsiflexion, daily weight-bearing duration, lower leg/foot strength, 386
neurodynamic dysfunction, stress, depression, and low back pain have 387
demonstrated an association with PHP or foot function and may contribute to the 388
response to physical therapy intervention.3, 12, 26, 28, 34, 43, 54, 58, 64 Additional 389
information derived from imaging including heel pad energy dissipation ratio, 390
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hyperemia, thickened plantar fascia, and heel spurs may also contribute to 391
prediction of response to treatment.27, 41, 63, 65, 66 While the historical, physical 392
examination and imaging factors listed above may occur more commonly in 393
some populations of PHP, they are also present in asymptomatic individuals and 394
the impact of these factors on clinical management including prediction of 395
successful response requires further investigation.17 396
397
398
Conclusion 399
400
Individuals with PHP for less than 7 months were more likely to respond to 401
the physical therapy interventions provided in the clinical trial, but age and BMI 402
were not predictive of treatment response. Despite the improved response of 403
individuals with symptoms less than 7 months, some individuals with symptoms 404
greater than 7 months were still able to demonstrate clinically meaningful 405
changes in response to physical therapy intervention. Participants in this trial 406
were obese based on the average BMI, yet were responsive to physical therapy 407
intervention despite previous reports of the associations of obesity with PHP and 408
a poor treatment response. The upper age range in this sample was limited and 409
further analysis is needed to assess the influence of age on treatment response 410
in individuals greater than 63 years old. Further research is needed to elucidate 411
additional strategies effective for PHP lasting longer than 7 months and matched 412
to individual patient characteristics and preferences. 413
414
415
References 416
417
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3. Allen RH, Gross MT. Toe flexors strength and passive extension range of motion of the 422
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Legends 590
591
Table 1: Participant characteristics and outcome measures at baseline and the 6 month follow-up (mean ± SD or frequency (%); n=60).
Variable Baseline
6 month Difference (95% CI)
Age in years (range) 48 ± 9 (27 - 63) - - Female participants (%) 33 (55) - - BMI in kg/m2 31.9 ± 7.5 - - Duration of symptoms in days 271.6 ± 212.7 - - NPRS 4.7 ± 1.7 1.7 ± 1.82 -3 (-2.4, -3.6) Change ≥ 2 points (%) - 42 (70) -
FAAM 57.5 ± 14.9 80 ± 16.5 22.5 (16.8, 28.2) Change ≥ 8 points (%) - 46 (77) - GRC ≥ +5 (%) - 40 (67) - Successful response (%) NPRS/FAAM/GRC criteria - 29 (48) - NPRS/FAAM criteria - 38 (63) - Abbreviations: BMI, body mass index; FAAM, Foot and Ankle Ability Measure; GRC, Global Rating of Change; NPRS, Numeric Pain Rating Scale.
592
593
Table 2: Odds ratio, sensitivity, specificity, and positive and negative likelihood ratio values of symptom duration less than 7.2 months as a predictor of successful response to physical therapy intervention.
Successful response criteria
Odds Ratio
(95% CI)
Sensitivity (95% CI)
Specificity (95% CI)
+ LR (95% CI)
- LR (95% CI)
NPRS/FAAM/GRC 4.2 (1.3, 13.8)
0.58 (0.41, 0.74)
0.75 (0.57, 0.87)
2.3 (1.2, 4.7)
0.56 (0.35, 0.89)
NPRS/FAAM 8.5 (2.5, 28.9)
0.76 (0.6, 0.87)
0.73 (0.52, 0.87)
2.8 (1.4, 5.6)
0.33 (0.18, 0.62)
Abbreviations: FAAM, Foot and Ankle Ability Measure; GRC, Global Rating of Change; LR, likelihood ratio; NPRS, Numeric Pain Rating Scale.
594
595
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596
Table 3: Outcome comparison of individuals with symptom duration above and below the 7.2 month cut point (mean ± SD or frequency (%); n=60). The p-values indicate the lowest value from MANCOVA for all imputed data sets unless otherwise indicated.
Outcome Variable Symptoms < 7.2 months (n=35)
Symptoms > 7.2 months (n=25)
Difference (95% CI)
p-value
FAAM Baseline 53.3 ± 15.4 63.2 ± 15 -9.9 (-1.9, -18) <.001 6 month 82 ± 17.2* 77.2 ± 17.5* 4.8 (-4.3, 13.9)* > .19* Change score 24.5 ± 17.2* 19.6 ± 17.5* 4.4 (-4.7, 13.5)* > .19* NPRS Baseline 5.5 ± 1.6 3.7 ± 1.5 1.8 (1, 2.6) <.001 6 month 1.4 ± 2.2* 2.1 ± 2.1* -0.7 (-1.8, 0.4)* > .08* Change score -4 ± 2.2* -1.7 ± 2.1* -2.3 (-1.2, -3.4)* > .08* GRC (%) 6 month 25 (68.6) 16 (64) - > .36† Abbreviations: FAAM, Foot and Ankle Ability Measure; GRC, Global Rating of Change; NPRS, Numeric Pain Rating Scale. *Adjusted for baseline score. †Calculated via Chi-square test. 597
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Paper No. FAI-14-0438.R1 entitled "Predictors of Response to Physical Therapy
Intervention for Plantar Heel Pain: A Secondary Analysis of Data from a Randomized
Clinical Trial."
Reviewer #1:
I'm still not satisfied with what disease state is being treated in this study. Plantar heel pain
is not always plantar fascitis. No imaging was attempted to discern a diagnosis outside of
"plantar heel pain".
RESPONSE TEXT CHANGES
In response to this comment and suggestions of the Associate
Editor, the inclusion/exclusion criteria have been more explicitly
defined in the Materials and Methods section.
Lines 84 - 88
In addition, further details have been added to the Introduction
to provide upfront clarification that plantar fasciitis is one of
many potential reasons for plantar heel pain, but is not the only
condition that produces plantar heel pain.
Lines 44 - 47
Additional limitations were added at the end of the discussion
to include consideration of factors that would be identified by
imaging.
Lines 389 - 396
COMMENT RESPONSE TEXT CHANGES
Abstract
I'm still not satisfied with what
disease state is being treated in this
study. Plantar heel pain is not
always plantar fascitis. No imaging
was attempted to discern a
diagnosis outside of "plantar heel
pain".
Please see response
above.
Please see text changes
indicated above.
Introduction
I'm still not satisfied with what
disease state is being treated in this
study. Plantar heel pain is not
always plantar fascitis. No imaging
was attempted to discern a
diagnosis outside of "plantar heel
pain".
Please see response
above.
Please see text changes
indicated above.
Methods
I'm still not satisfied with what
disease state is being treated in this
study. Plantar heel pain is not
always plantar fascitis. No imaging
was attempted to discern a
diagnosis outside of "plantar heel
pain".
Please see response
above.
Please see text changes
indicated above.
Results
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I'm still not satisfied with what
disease state is being treated in this
study. Plantar heel pain is not
always plantar fascitis. No imaging
was attempted to discern a
diagnosis outside of "plantar heel
pain".
Please see response
above.
Please see text changes
indicated above.
Discussion
I'm still not satisfied with what
disease state is being treated in this
study. Plantar heel pain is not
always plantar fascitis. No imaging
was attempted to discern a
diagnosis outside of "plantar heel
pain".
Please see response
above.
Please see text changes
indicated above.
Conclusion
I'm still not satisfied with what
disease state is being treated in this
study. Plantar heel pain is not
always plantar fascitis. No imaging
was attempted to discern a
diagnosis outside of "plantar heel
pain".
Please see response
above.
Please see text changes
indicated above.
Associate Editor: Campbell, John
Comments to the Author:
The authors should be congratulated on an outcome study that investigates a very common
condition, plantar heel pain. I still share Reviewer #1's concerns which seem valid. The
authors do not provide any inclusion/diagnostic criteria for PHP (our readers are mainly
clinicians who treat numerous pathologies...PF? tarsal tunnel? Baxter's nerve extrapment?
fat pad atrophy?). I think the diagnostic criteria must be more explicitly defined. (this is what
Reviewer #1 was getting at in asking about imaging)
Thank you for the additional clarification of Reviewer #1’s concerns. Please see the response
to reviewer #1’s comment and text changes indicated above.
Were there any other treatment methods? NSAIDs? Night splint? Injections? Immobilization
(boot or cast)? You must clarify this or it will be seen as an unspoken confounding factor.
No other interventions were provided other than those listed in the Materials and Methods
section. Additional information has been added to indicate the number of participants who
were taking medication at the start of the trial and to indicate that no other interventions
were utilized. Please see lines 138 – 145.
Additionally, I still have trouble accepting the Methods, which treated the pateints with two
different regimens but then combined the data to look at correlation with BMI, age, etc.
Although there may be some statistical precedence for this, I believe many of our readers
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will look skeptically on this. This would likely need to be more clearly explained for my
satisfaction.
Additional information has been added to the Statistical Analysis section to include
references to recommended procedures for this type of analysis and other studies that have
used similar procedures. Please see lines 150 – 159.
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