Comparison of Usual Podiatric Care and Early Physical Therapy for Plantar Heel Pain
Condition: Fasciitis, Plantar
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Physical therapy after initial podiatry visit; Usual care provided by podiatry
Intervention type(s): Other; Other
Intervention description(s): Individuals in the early physical therapy group will receive physical therapy in accordance with the American Physical Therapy Association plantar heel pain practice guidelines and recent evidence in support of manual therapy intervention. Treatment provided will be based on identified impairments and may include manual therapy (joint and soft tissue mobilization/thrust manipulation to the lower half of the body), lower leg and plantar foot specific stretching/self mobilization, foot and lower leg muscle performance training, night splints, taping, over the counter orthotics/heel cup/heel cushion, and iontophoresis. Specific intervention will be selected at the discretion of the treating physical therapist.; Individuals in the usual podiatric care group will receive care typical of podiatry management of plantar heel pain. According to practice guidelines, the first 6 weeks of treatment includes foot taping/padding, home stretching exercises, arch support/heel cup, shoe recommendations, oral anti-inflammatories, and corticosteroid injection. The next 6 months may include corticosteroid injection, custom orthotics, night splint, immobilization, and physical therapy. If unresponsive after 6 months of treatment, extracorporal shock wave therapy or a fasciotomy surgery is considered. Additionally, the podiatrist may order radiographs or ultrasound imaging within their scope of practice. Specific intervention will be selected at the discretion of the treating podiatrist.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fasciitis, Plantar; Heel Pain; Physical Therapy; Podiatry; Musculoskeletal Manipulations; Exercise Therapy