Randomized multicenter follow-up trial on the effect of radiotherapy for plantar fasciitis (painful heels spur) depending on dose and fractionation – a study protocol

Holtmann, Henrik; Niewald, Marcus; Prokein, Benjamin; Graeber, Stefan; Ruebe, Christian

doi:10.1186/s13014-015-0327-6

Cited by 8 publications

(13 citation statements)

References 33 publications

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“…However, there are multiple articles about other forms of treatment, including endoscopic release, 4,14,19,20,21 plateletrich plasma injections, 13,22,32 botulinum toxin A injection, 11,24 percutaneous frequency coblation, 31,35 extracorporeal shock wave therapy, 23,26 and radiotherapy. 2,15 One has to ask the question, If there are so many different modalities described, do any of them actually work? Furthermore, if open partial plantar fascial release had good results, then it is unlikely that so many alternative treatments would be researched.…”

Section: Discussionmentioning

confidence: 99%

Long-Term Outcome of Open Plantar Fascia Release

MacInnes

Roberts

Kimpton³

et al. 2015

Foot Ankle Int.

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Background: Plantar fasciitis is thought to be a self-limiting condition best treated by conservative measures, but despite this many patients have a prolonged duration of symptoms and surgery may be indicated. Partial plantar fascial release is reported to have a short-term success rate of up to 80%, but anecdotally this was not thought to represent our local experience. Methods: An audit of long-term patient-reported outcomes following open partial plantar fascia release was performed. A total of 30 patients (33 feet) were identified over a 10-year period and case notes were reviewed. Patients were contacted by letter and invited to complete 2 validated patient-reported outcome score questionnaires (Visual Analog Scale-Foot and Ankle [VAS-FA] and Manchester Oxford Foot Questionnaire [MOXFQ]). Responses were received from 24 patients (26 feet). The average ages were 42.4 (range 24-61) for male and 46.2 (range 33-60) for female patients, with a female/male ratio of 2.7:1. The average duration of treatment prior to operative intervention was 3.1 years (range 1-5). Preoperatively, our cohort underwent a range of conservative measures. All patients were reviewed postoperatively, and average time from surgery to completion of questionnaires was 80 months (range 14-130). Results: The outcomes were worse in patients who had received preoperative steroid injections and this was found to be statistically significant. The mean MOXFQ score was 33.6 ± 3.9 (0-64). Mean VAS-FA score was 57.8 ± 4.9 (24-100). Conclusion: This study found a negative correlation between duration of follow-up and outcome, in both MOXFQ and VAS-FA, showing that patients continued to improve many years postoperatively. The authors also found worse outcomes with preoperative steroid injections, better outcomes in older patients, and a weak gender bias, suggesting results in men were better than those in women. A prolonged recovery period and generally poor outcomes leads the authors to suggest that open plantar fascia release is of questionable clinical value and that patients may improve in the natural course of the disease, in spite of surgery. Level of Evidence: Level III, comparative study.

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Section: Discussionmentioning

confidence: 99%

Long-Term Outcome of Open Plantar Fascia Release

MacInnes

Roberts

Kimpton³

et al. 2015

Foot Ankle Int.

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“…Described risk factors are old age, obesity and foot or leg deformities. Further data concerning histology, symptoms and alternative therapy methods are given elsewhere [5, 6]. …”

Section: Introductionmentioning

confidence: 99%

Randomized multicenter follow-up trial on the effect of radiotherapy on painful heel spur (plantar fasciitis) comparing two fractionation schedules with uniform total dose: first results after three months’ follow-up

et al. 2015

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BackgroundOur first trial on radiotherapy for painful heel spur published in 2012 comparing the analgesic effect of a standard dose (6 × 1.0Gy within three weeks) to that of a very low one (6 × 0.1Gy within three weeks) resulted in a highly significant superiority of the standard dose arm. In the meantime, experimental data have shown that lower single doses in the range of 0.5 – 0.7Gy might be even more effective than the current standard dose of 1.0 Gy. Therefore, we conducted a second trial comparing the analgesic effect of standard single doses of 1.0Gy to that of low single doses of 0.5Gy using uniform total doses of 6Gy.Patients and methodsOne hundred twenty-seven patients were randomized to receive radiation therapy either with a total dose of 6.0Gy applied in 6 fractions of 1.0Gy twice weekly (standard dose) or with the same total dose applied in 12 fractions of 0.5Gy three times weekly (experimental dose). In all patients lateral opposing 6MV photon beams were used. The results were measured using Visual analogue scale (VAS), Calcaneodynia score (CS) and SF-12 health survey. The first phase of this trial ended after a three months’ follow-up; it will be continued up to 48 weeks.ResultsNine patients had to be excluded after randomization either due to the withdrawal of informed consent to radiotherapy by the patients or radiotherapy with an incorrect dosage. The groups were comparable concerning biographical and disease data. The mean calcaneodynia score (CS) was higher in the experimental group (p = 0.002). After three months’ follow-up, we saw a very favorable pain relief in both arms (decline of VAS score: standard arm 42 points, experimental arm 44 points (n.s.), but we did not notice any statistically significant difference between the arms neither concerning the pain parameters nor the quality of life parameters. No relevant acute side effects were recorded.ConclusionsFavorable laboratory results could not be translated into an enhanced pain relief in our patients. This trial was terminated after the interim analysis (127 patients randomized). Further trials will be necessary to explore the best fractionation schedule.This trial has been approved by the expert panel of the DEGRO as well as by the Ethics committee of the Saarland Physicians’ chamber.Trial registrationCurrent trial registration at German Clinical Trials Register with the number DRKS00004458

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“…Several trials have been conducted to assess the utility of low dose irradiation in the management of heel spur and plantar fasciitis (11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26). While the exact mechanism of pain relief by irradiation is an area of research, RT may also induce a placebo effect in some patients (24). In terms of dose and fractionation, there is no standard fractionation scheme for the irradiation of painful heel spur and plantar fasciitis.…”

Section: Discussionmentioning

confidence: 99%

“…In terms of dose and fractionation, there is no standard fractionation scheme for the irradiation of painful heel spur and plantar fasciitis. Several dose-fractionation schemes have been evaluated, and total delivered doses in the range of 3 to 12 Gy have been found to be effective (24). In the study by Seegenschmiedt et al (11), 3 dose-fractionation schemes were comparatively assessed, and 10x0.5 Gy to a total dose of 5 Gy was reported to be superior than 10x0.3 Gy to a total dose of 3 Gy and 12x1 Gy to a total dose of 12 Gy in terms of pain relief.…”

Section: Discussionmentioning

confidence: 99%

“…RT has a long history in the management of painful heel spur and plantar fasciitis. Accumulated data from several centers have consistently reported effective palliation of painful plantar fasciitis and heel spur; however, dose fractionation schemes and treatment fields may vary among the institutions and are typically based on retrospective data and experiences (2,(11)(12)(13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26).…”

Section: Original Articlementioning

confidence: 99%

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Evaluation of the radiotherapeutic management of refractory painful heel spur and plantar fasciitis: a single center experience of 45 years

Beyzadeoğlu¹,

Sager²,

Dincoglan³

et al. 2020

GMJ

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Aim: Heel spur is exostosis of the calcaneus. Plantar fasciitis and heel spur constitute a very common cause of plantar pain, which may be managed with radiation therapy (RT). In this study, we assessed the radiotherapeutic management of refractory painful heel spur and plantar fasciitis. Methods:In this retrospective study, we report our single center experience with RT for refractory painful heel spur and plantar fasciitis management over a period of 45 years and describe patient and treatment characteristics.Results: Between 1974 and 2019, a total of 4904 patients received RT at our department using cobalt-60 teletherapy machine for the management of refractory painful heel spur and plantar fasciitis. Out of the total 4904 patients, 2012 patients (41%) were male and 2892 patients (59%) were female. The median age was 51 (range: 41-85) years. All patients had received previous therapies for refractory painful heel spur and plantar fasciitis before the management with RT. Total RT dose was 8 Gy delivered in 2 consecutive days with daily fractions of 4 Gy using 2 opposing anterior-posterior RT fields to both heels without bolus material. Treatment response was assessed 3 to 5 weeks after the completion of RT. Response to RT was complete in 3579 patients (73%), partial in 1188 patients (24.2%), and none in 137 patients (2.8%). No therapyrelated toxicity was observed in the whole series. Conclusion:RT for refractory painful heel spur and plantar fasciitis may offer effective palliation of pain and may be considered as a viable therapeutic option for selected patients exhausted with other treatment modalities. ABSTRACT Date

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Randomized multicenter follow-up trial on the effect of radiotherapy for plantar fasciitis (painful heels spur) depending on dose and fractionation – a study protocol

Cited by 8 publications

References 33 publications

Long-Term Outcome of Open Plantar Fascia Release

Long-Term Outcome of Open Plantar Fascia Release

Randomized multicenter follow-up trial on the effect of radiotherapy on painful heel spur (plantar fasciitis) comparing two fractionation schedules with uniform total dose: first results after three months’ follow-up

Evaluation of the radiotherapeutic management of refractory painful heel spur and plantar fasciitis: a single center experience of 45 years

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