Effectiveness of physical therapy treatment in addition to usual podiatry management of plantar heel pain: a randomized clinical trial

Shane M McClinton, Bryan C Heiderscheit, Thomas G McPoil, Timothy W Flynn, Shane M McClinton, Bryan C Heiderscheit, Thomas G McPoil, Timothy W Flynn

Abstract

Background: Many patients will seek care from a podiatrist for plantar heel pain (PHP), while few of these patients will also be seen by a physical therapist. Physical therapists can provide treatment that is not a part of routine podiatric care for PHP and may provide additional improvement. Therefore, the purpose of this study was to examine the effects of interdisciplinary care for PHP that incorporated physical therapy treatment after initiating podiatric treatment.

Methods: Eligible individuals with PHP that presented to a podiatrist were randomized to receive usual podiatric care (uPOD) or usual podiatric care plus physical therapy treatment (uPOD+PT). The primary outcome was change in foot and ankle ability measure (FAAM) at 6-months. Secondary outcomes included change in numeric pain rating scale (NPRS), patient-reported success, and 6-week and 1-year endpoints. Patient-reported success was defined as the top two global rating of change scale rankings. Primary analysis was intention-to-treat (ITT) using analysis by covariance adjusted to baseline scores, and a secondary per-protocol (PP) analysis was performed analyzing only those who completed treatment.

Results: Ninety-five individuals participated and were included in the ITT analysis, and 79 were included in the PP analysis. For the primary outcome of FAAM change from baseline to 6-months, both groups improved significantly (uPOD+PT: 26.8 [95% CI 21.6, 31.9]; uPOD: (20 [15.6, 24.4]), but there was no between-group difference (4.3 [- 1, 9.6]). For secondary outcomes, the uPOD+PT group demonstrated greater improvement in NPRS at 6 weeks (0.9 [0.3, 1.4]) and 1 year (1.5 [0.6, 2.5]) in the ITT analysis. In the PP analysis, the uPOD+PT group demonstrated greater improvement in FAAM at 6 months (7.7 [2.1, 13.3]) and 1 year (5.5 [0.1, 10.8]), NPRS at 6 weeks (0.9 [0.2, 1.6]), 6 months (1.3 [0.6, 2.1]) and 1 year (1.3 [0.6, 2.1]), and in patient-reported success (relative risk [95% CI]) at 6 weeks (2.8 [1.1, 7.1]), 6 months (1.5 [1.1, 2.1]), and 1 year (1.5 [1.1, 1.9]).

Conclusions: There was no significant benefit of uPOD+PT in the primary outcome of FAAM change at 6 months. Secondary outcomes and PP analysis indicated additional benefit of uPOD+PT, mostly observed in individuals who completed treatment.

Trial registration: Prospectively registered May 24, 2013 at www.clinicaltrials.gov (NCT01865734).

Keywords: Exercise; Manual therapy; Physiotherapy; Plantar fasciitis; Podiatrist.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram of participant recruitment and retention. *Upper age limit was 60 years for the first 5 months of enrollment and increased to 70 for the next 32 months until enrollment ended. †Reasons provided were because the patient did not live near the clinic to attend regular appointments (n = 23), did not have time to participate (n = 27), was concerned about additional copayments or treatment-related costs (n = 19), or chose not to participate (n = 20). ‡Completers were defined as individuals who attended clinic appointments or follow-up according to the plan mutually set by the patient and provider as indicated in the participant’s medical record or completed at least 4 visits with a physical therapist if assigned to the usual podiatric care plus physical therapy treatment (uPOD+PT) group [–55]. Individuals that did not complete treatment were participants who failed to follow-up as planned. PHP, plantar heel pain; uPOD, usual podiatric care; FAAM, foot and ankle ability measure
Fig. 2
Fig. 2
Foot and ankle ability measure (FAAM) at each assessment for the primary intention-to-treat (ITT) and per-protocol (PP) analyses. Higher scores indicate higher function on the FAAM. *Change in FAAM score from baseline significantly greater with usual podiatric care plus physical therapy treatment (uPOD+PT) versus usual podiatric care (uPOD) (P < 0.05)
Fig. 3
Fig. 3
Numeric pain rating scale (NPRS) outcomes at each assessment for the primary intention-to-treat (ITT) and per-protocol (PP) analyses. Higher scores indicate greater pain intensity. *Change in NPRS from baseline significantly lower with usual podiatric care plus physical therapy treatment (uPOD+PT) versus usual podiatric care (uPOD) at P < 0.05 level or †P < 0.001

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