Comparison of Usual Podiatric Care and Early Physical Therapy for Plantar Heel Pain
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 1/23/2019 |
| Start Date: | December 2013 |
| End Date: | November 2017 |
Comparison of Usual Podiatric Care and Early Physical Therapy for Plantar Heel Pain: A Randomized Clinical Trial
Plantar heel pain (PHP) is one of the most common foot conditions in podiatry and physical
therapy practice and often is associated with chronic symptoms, and disability. Persistence
of symptoms adds to the economic burden of PHP and cost-effective solutions are needed to
reduce this burden. Currently, there is wide variation in treatment, cost, and outcomes of
care for PHP. Two practice guidelines are available to direct management patterns, but the
guidelines and recent evidence of PHP interventions are unclear about the timing and
influence of physical therapy in the multidisciplinary management of PHP. The purpose of this
investigation is to compare the outcomes and costs associated with early physical therapy
(ePT) following initial presentation to podiatry versus usual podiatric care (uPOD) in
individuals with PHP. It is hypothesized that there will be greater improvement and/or
reduced costs associated with either ePT or uPOD. In this study, 112 individuals with PHP
will be randomized to receive uPOD or ePT after an initial visit with a podiatrist. Treatment
provided in the uPOD group will reflect usual management patterns and intervention will be
determined by the podiatrist. Treatment provided in the ePT group will be determined by the
physical therapist and will focus on impairment-based manual therapy and exercise to the
lower half of the body. In addition, evidence-based pain modulating modalities will be
integrated into ePT treatment. Comparisons will be made between groups in the Foot and Ankle
Ability measure (FAAM), the European Quality of Life (EQ-5D), Numeric Pain Rating Scale
(NPRS), Global Rating of Change (GROC), and cost of treatment at 6, 26, and 52, weeks. The
association between successful outcome based on GROC score and patient expectation of
physical therapy or podiatry, and general expectations of symptom improvement will be
analyzed. The results of this investigation will help to determine the impact of ePT to
inform practice, update existing guidelines to reduce practice variation, and identify the
most cost effective treatment for patients with PHP.
therapy practice and often is associated with chronic symptoms, and disability. Persistence
of symptoms adds to the economic burden of PHP and cost-effective solutions are needed to
reduce this burden. Currently, there is wide variation in treatment, cost, and outcomes of
care for PHP. Two practice guidelines are available to direct management patterns, but the
guidelines and recent evidence of PHP interventions are unclear about the timing and
influence of physical therapy in the multidisciplinary management of PHP. The purpose of this
investigation is to compare the outcomes and costs associated with early physical therapy
(ePT) following initial presentation to podiatry versus usual podiatric care (uPOD) in
individuals with PHP. It is hypothesized that there will be greater improvement and/or
reduced costs associated with either ePT or uPOD. In this study, 112 individuals with PHP
will be randomized to receive uPOD or ePT after an initial visit with a podiatrist. Treatment
provided in the uPOD group will reflect usual management patterns and intervention will be
determined by the podiatrist. Treatment provided in the ePT group will be determined by the
physical therapist and will focus on impairment-based manual therapy and exercise to the
lower half of the body. In addition, evidence-based pain modulating modalities will be
integrated into ePT treatment. Comparisons will be made between groups in the Foot and Ankle
Ability measure (FAAM), the European Quality of Life (EQ-5D), Numeric Pain Rating Scale
(NPRS), Global Rating of Change (GROC), and cost of treatment at 6, 26, and 52, weeks. The
association between successful outcome based on GROC score and patient expectation of
physical therapy or podiatry, and general expectations of symptom improvement will be
analyzed. The results of this investigation will help to determine the impact of ePT to
inform practice, update existing guidelines to reduce practice variation, and identify the
most cost effective treatment for patients with PHP.
This investigation will be a randomized clinical trial comparing participant-reported
outcomes and cost-effectiveness of ePT and uPOD with follow up extending to 1 year. Following
eligibility screening and completion of study questionnaires participants will be randomized
using concealed envelopes and proceed with the intervention of their assigned group. Outcomes
will be collected at 6 weeks, 6 months, and 1 year after initial presentation. All outcomes
will be completed by the patient without any influence from investigators aware of the group
assignment. Data entry and processing will occur by an investigator blinded to group
allocation. A small financial incentive will be provided to facilitate completion of outcome
measures over the study duration.
Statistical Analysis: Baseline group variables will be summarized using the mean and standard
deviation for continuous measures and percentages for categorical measures. Independent
t-tests (p<0.05, two-tailed) or the appropriate nonparametric test will be used to compare
between group differences in baseline characteristics. Parametric test assumptions will be
analyzed for all continuous variables by visual inspection of histograms, use of skewness
score within double the standard error of skewness criteria, and Levene's test for
homogeneity of the variance. A repeated measures analysis of variance will be used to compare
group differences in the FAAM, NPRS, EQ-5D, and number of office visits associated with
treatment at each time point. Results will be reported as the group mean, mean difference
between groups, 95% confidence intervals, f-value, p-value, power, and effect size. The
chi-square test will be used to compare GROC scores between groups at each time point and
results will be reported as the chi-square value, p-value, and the frequency per category.
The types of treatment based on Current Procedural Terminology (CPT) and Healthcare Common
Procedure Coding System (HCPS) codes provided per group will be reported as percentages.
Analysis of covariance will be used if any group differences are observed in participant
characteristics. Intention to treat analysis will be performed by comparing the complete case
analysis to multiple imputation analysis. Multiple imputed data sets will be generated using
the Multivariate Imputation by Chained Equations algorithm with SPSS 19.0 for Windows (SPSS
Inc., Chicago, IL, USA). Multinomial logistic regression will be used to obtain pooled
regression estimates from the data sets which will be used for analysis. Post-randomization
exclusion of included participants that did not meet eligibility criteria or that did not
receive intervention will be considered for exclusion of the analysis by an independent,
blinded adjudication committee that will evaluate all randomized participants. Any
cross-overs will be analyzed in the original group they were assigned to and compared to an
analysis that excludes cross-overs.
Participant expectations and preferences for ePT or uPOD will be categorized into 3
categories; matched, unmatched and neutral. Participants will be labelled 'matched' if they
are allocated to a group for which they have expressed a higher expectation of benefit. A
higher expectation will be denoted by comparison of visual analog ratings between the groups
(ePT and uPOD). Unmatched participants will be those who are allocated to the treatment group
for which they have a lower expectation of benefit. Neutral participants will be those who
indicate the same level of expectation for both treatments. Similar categorizations will be
made for participant preference based upon their response to the treatment preference
question. General expectations of improvement will be dichotomized into met or unmet based
upon rankings at the 6 week, 6 month, and 1 year follow-up relative to baseline rankings.
Participants that demonstrate 6 week, 6 month, and 1 year ranks equal to or higher than
baseline will be considered to have met their global expectations of improvement.
Participants that demonstrate rankings below baseline expectations will be considered to have
unmet global expectations of improvement. A chi-square test of independence will be used to
compare the proportions of individuals with matched/unmatched/neutral expectations or
preferences to global expectations (met or unmet). In addition, differences in expectation
and preference categories will be analyzed relative to treatment success using a chi-square
test of independence. Treatment success will be determined by the GROC at each time period
with success defined as a GROC of +5, "a great deal better," or greater.
Power Analysis: Sample size estimates were calculated based on the primary outcome measure,
the FAAM, at 6 months. In the absence of research comparing physical therapy and podiatry
interventions or podiatry interventions using the FAAM as an outcome measure, sample size
calculations were based on achieving a clinically meaningful difference between the groups
and details from a recent clinical trial by Cleland et al that used similar methods to this
investigation. Sample size estimate was made using G*Power 3.1.5 based on detecting a
difference between groups greater than the minimal clinically important difference (MCID; ie,
9 point change) of the FAAM at 6 months with an alpha level of 0.05, 80% power, and pooled
sample variance of 14.5 from Cleland et al This resulted in an effect size of 0.62 and 42
participants needed per group. This estimate is similar to the effect size of 0.69 achieved
in the Cleland et al study that had 27 subjects per 2 treatment groups. To account for
participants who drop-in or drop-out of treatment, in addition to the possibility of some
participants not returning the FAAM questionnaire, the sample will be increased by 33%
resulting in 56 participants per group. This estimate is conservative relative to the 3%
drop-out rate and 7% rate of individuals that did not return outcome forms at the 6 month
follow-up in the Cleland et al investigation. Significant effort will be made to retain
subjects to include financial incentives and follow-up by the research assistant to assure
completion and return of all outcome forms. The focus, and consequently the power analysis,
of this investigation is on functional outcome (based on FAAM scores) and therefore may
result in underpowered analysis of secondary variables.
outcomes and cost-effectiveness of ePT and uPOD with follow up extending to 1 year. Following
eligibility screening and completion of study questionnaires participants will be randomized
using concealed envelopes and proceed with the intervention of their assigned group. Outcomes
will be collected at 6 weeks, 6 months, and 1 year after initial presentation. All outcomes
will be completed by the patient without any influence from investigators aware of the group
assignment. Data entry and processing will occur by an investigator blinded to group
allocation. A small financial incentive will be provided to facilitate completion of outcome
measures over the study duration.
Statistical Analysis: Baseline group variables will be summarized using the mean and standard
deviation for continuous measures and percentages for categorical measures. Independent
t-tests (p<0.05, two-tailed) or the appropriate nonparametric test will be used to compare
between group differences in baseline characteristics. Parametric test assumptions will be
analyzed for all continuous variables by visual inspection of histograms, use of skewness
score within double the standard error of skewness criteria, and Levene's test for
homogeneity of the variance. A repeated measures analysis of variance will be used to compare
group differences in the FAAM, NPRS, EQ-5D, and number of office visits associated with
treatment at each time point. Results will be reported as the group mean, mean difference
between groups, 95% confidence intervals, f-value, p-value, power, and effect size. The
chi-square test will be used to compare GROC scores between groups at each time point and
results will be reported as the chi-square value, p-value, and the frequency per category.
The types of treatment based on Current Procedural Terminology (CPT) and Healthcare Common
Procedure Coding System (HCPS) codes provided per group will be reported as percentages.
Analysis of covariance will be used if any group differences are observed in participant
characteristics. Intention to treat analysis will be performed by comparing the complete case
analysis to multiple imputation analysis. Multiple imputed data sets will be generated using
the Multivariate Imputation by Chained Equations algorithm with SPSS 19.0 for Windows (SPSS
Inc., Chicago, IL, USA). Multinomial logistic regression will be used to obtain pooled
regression estimates from the data sets which will be used for analysis. Post-randomization
exclusion of included participants that did not meet eligibility criteria or that did not
receive intervention will be considered for exclusion of the analysis by an independent,
blinded adjudication committee that will evaluate all randomized participants. Any
cross-overs will be analyzed in the original group they were assigned to and compared to an
analysis that excludes cross-overs.
Participant expectations and preferences for ePT or uPOD will be categorized into 3
categories; matched, unmatched and neutral. Participants will be labelled 'matched' if they
are allocated to a group for which they have expressed a higher expectation of benefit. A
higher expectation will be denoted by comparison of visual analog ratings between the groups
(ePT and uPOD). Unmatched participants will be those who are allocated to the treatment group
for which they have a lower expectation of benefit. Neutral participants will be those who
indicate the same level of expectation for both treatments. Similar categorizations will be
made for participant preference based upon their response to the treatment preference
question. General expectations of improvement will be dichotomized into met or unmet based
upon rankings at the 6 week, 6 month, and 1 year follow-up relative to baseline rankings.
Participants that demonstrate 6 week, 6 month, and 1 year ranks equal to or higher than
baseline will be considered to have met their global expectations of improvement.
Participants that demonstrate rankings below baseline expectations will be considered to have
unmet global expectations of improvement. A chi-square test of independence will be used to
compare the proportions of individuals with matched/unmatched/neutral expectations or
preferences to global expectations (met or unmet). In addition, differences in expectation
and preference categories will be analyzed relative to treatment success using a chi-square
test of independence. Treatment success will be determined by the GROC at each time period
with success defined as a GROC of +5, "a great deal better," or greater.
Power Analysis: Sample size estimates were calculated based on the primary outcome measure,
the FAAM, at 6 months. In the absence of research comparing physical therapy and podiatry
interventions or podiatry interventions using the FAAM as an outcome measure, sample size
calculations were based on achieving a clinically meaningful difference between the groups
and details from a recent clinical trial by Cleland et al that used similar methods to this
investigation. Sample size estimate was made using G*Power 3.1.5 based on detecting a
difference between groups greater than the minimal clinically important difference (MCID; ie,
9 point change) of the FAAM at 6 months with an alpha level of 0.05, 80% power, and pooled
sample variance of 14.5 from Cleland et al This resulted in an effect size of 0.62 and 42
participants needed per group. This estimate is similar to the effect size of 0.69 achieved
in the Cleland et al study that had 27 subjects per 2 treatment groups. To account for
participants who drop-in or drop-out of treatment, in addition to the possibility of some
participants not returning the FAAM questionnaire, the sample will be increased by 33%
resulting in 56 participants per group. This estimate is conservative relative to the 3%
drop-out rate and 7% rate of individuals that did not return outcome forms at the 6 month
follow-up in the Cleland et al investigation. Significant effort will be made to retain
subjects to include financial incentives and follow-up by the research assistant to assure
completion and return of all outcome forms. The focus, and consequently the power analysis,
of this investigation is on functional outcome (based on FAAM scores) and therefore may
result in underpowered analysis of secondary variables.
Inclusion Criteria:
- Clinical diagnosis of Plantar Heel Pain: Tenderness to palpation of the plantar heel,
pain associated with first step after waking, or pain with progression of daily
weightbearing
- Patient's primary complaint is plantar heel pain
Exclusion Criteria:
- Score less than 74/84 on the Foot and Ankle Ability Measure activities of daily living
(ADL) subscale
- Unable to complete questionnaires
- No treatment for heel pain in last 6 weeks
- Duration of symptoms greater than 1 year
- Current fracture of the lower leg, ankle, or foot
- Neurological condition affecting function of lower leg
- Advanced peripheral artery disease
- Rheumatoid arthritis
- Osteoporosis
- Active cancer
- Prolonged steroid use
- Surgery of the lower leg, ankle, or foot
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