Research Ankle/Foot July 22, 2024

Shock Wave, Sham, Exercise or Advice Plus Foot Orthoses for Treating Plantar Fasciopathy

Treating plantar fasciopathy

Introduction

About one year ago, we published a research review based on the study of Riel et al. (2023) that studied the options for improving pain in people with plantar fasciopathy. No clinical improvement surpassing the minimally clinically important difference was found in any of the groups, whether they received advice plus a heel cup alone (PA) versus advice plus a heel cup and lower limb exercise (PAX) versus PAX plus corticosteroid injection (PAXI). Since that study showed no treatment was superior to one another, treating plantar fasciopathy remains difficult for the clinician. As it is a musculoskeletal degenerative condition that affects 3.6% to 9.6% of the population, many physiotherapists are seeing these patients but unfortunately, it remains a stubborn condition to tackle. The general idea that strengthening may help relieve the complaints of plantar fasciopathy is transposed from the evidence in patellar and Achilles tendinopathy but as the plantar fascia is not considered a regular tendon, as it has no direct in-line muscular attachment, evidence derived from other body parts can not be directly transferred here. Considering shock wave therapy, evidence is inconsistent and not always methodologically rigid. That is why these study authors wanted to conduct this research comparing all available options in the management of plantar fasciopathy.

 

Methods

This randomized controlled trial aimed to investigate the effectiveness of radial extracorporeal shock wave therapy (rESWT), sham rESWT, and a standardized exercise program in combination with advice plus customized foot orthoses compared with advice plus customized foot orthoses alone for treating plantar fasciopathy heel pain.

Eligible patients were between 18 and 70 years of age and were referred by their general practitioner for their heel pain. Localized pain and tenderness on palpation of the medial calcaneal tuberosity had to be present for more than three months with an intensity of minimal 3 points during activity in the previous week on the Numeric Rating Scale (NRS).

Patients corresponding to the required inclusion criteria were invited for a clinical examination and baseline assessment before being randomized to one of four treatment groups. On this visit, the physiotherapist communicated standardized information on pathogenesis, etiology, and prognosis, and advised them to stay physically active within pain tolerance and to use proper footwear with cushioning. An educational leaflet with this information was also provided. Next, all patients were referred to a Certified Prosthetist/Orthotist who performed a 3D scan of the foot to prepare the customized foot orthoses from a semi-rigid material.

Then, the participants were randomly assigned to one of four groups:

  • Advice plus customized foot orthoses alone
  • The same advice and orthoses plus radial extracorporeal shock wave therapy (rESWT)
  • The same advice and orthoses plus sham-rESWT
  • The same advice and orthoses plus a high-load exercise program
Treating Plantar Fasciopathy
From: Heide et al., Br J Sports Med. (2024)

 

  • In the group receiving Advice and Custom Orthoses, all participants received standardized advice on maintaining physical activity, proper footwear, and load management. Custom orthoses were provided following a 3D foot scan and were made of a semi-rigid material. This is the control group receiving the usual care protocol.
  • The rESWT Group received three weekly treatments of rESWT.
  • The Sham-rESWT Group received three weekly treatments of a sham procedure identical in application but without therapeutic effect
  • The Exercise group performed a program consisting of unilateral heel raises performed on a step with a rolled towel under the toes, and unilateral leg squats. Exercises were progressively loaded, starting with loads at 12 repetition maximum (RM) and reducing to 6 RM over 12 weeks, with three sets per exercise. This program was performed three times a week for 12 weeks, with eight of the sessions supervised by a physiotherapist.
Treating Plantar Fasciopathy
From: Heide et al., Br J Sports Med. (2024)

 

The primary outcome measure in this study was heel pain during activity in the previous week, assessed using the NRS at 6 months. The minimally clinically important difference is 2 points. Other secondary outcomes were assessed at baseline, 3 months, 6 months, and 12 months.

  • Heel pain at rest in the previous week (NRSr),
  • RAND-12 Health Status Inventory (RAND-12) score, which assesses health-related quality of life. It consists of 12 questions and generates two scores: the Mental Component Summary score (MCS12) and the Physical Component Summary score (PCS12). Scores range from 0 to 100, with higher scores indicating better health
  • Foot Function Index Revised Short Form (FFI-RS) score, which is a region-specific patient-reported outcome measure that consists of 34 questions with five subscales: pain, stiffness, difficulty, activity limitations, and social issues. The total score ranges from 0 to 100, with lower scores indicating better foot health.
  • Patient Global Impression of Change (PGIC) scale, where the patients answered one question: ‘Compared with the start of the study, how is your general health status today?’. Possible responses ranged from 1 to 7, where 1 was ‘very much better’, 4 was ‘no change’ and 7 was ‘very much worse’.

 

Results

Two hundred participants were randomly and equally assigned to one of four treatment groups. Apart from smoking status, the presence of bilateral pain, the duration of symptoms, and the use of daily analgesics the groups appeared equal.

Treating Plantar Fasciopathy
From: Heide et al., Br J Sports Med. (2024)

 

Primary Outcome: No significant between-group differences in pain reduction were found between the intervention groups and the control group at the 6-month follow-up. Significant improvements that exceeded the predefined threshold of clinical relevance were observed within every group. This means that adding those treatments to advice and customized foot orthoses provides no additional benefit.

Treating Plantar Fasciopathy
From: Heide et al., Br J Sports Med. (2024)

 

For the Secondary Outcomes, similarly, no significant between-group differences were observed in secondary outcomes, including heel pain at rest (NRSr), Foot Function Index Revised Short Form (FFI-RS), RAND-12 Health Status Inventory scores, and Patient Global Impression of Change (PGIC). Mean within-group changes in secondary outcome measures from baseline to 6-month follow-up showed statistically significant improvement in all intervention groups except for the MCS12 score derived from the RAND-12 in the sham-rESWT group.

Treating Plantar Fasciopathy
From: Heide et al., Br J Sports Med. (2024)

 

Treating Plantar Fasciopathy
From: Heide et al., Br J Sports Med. (2024)

 

Questions and thoughts

This study demonstrated that there is currently no single best way to treat plantar fasciopathy. All interventions improved the complaints, but no more than the comparator intervention which was advice plus customized foot orthoses. It appears that when you educate your patient with plantar fasciopathy right and provide him with foot orthoses, no extra treatments would be necessary. This might be frustrating for some since we want to help those people out. However, based on the findings from this study, there is no benefit from other treatments, and thus, there is no evidence to support the use of them.

The results of this study follow the outcomes of the study by Riel et al. (2023) which we reviewed about a year ago. It might be possible that in future trials, better results are found, especially since we know that the plantar fascia can not be directly compared to other tendons where exercise treatments are used.

The per-protocol analysis revealed no statistically significant between-group differences. High compliance was registered in the ESWT and sham ESWT groups, but no details were given. In the exercise group, this was slightly lower (74%). Could this have made a difference? It is, however, not surprising that people who have to attend only 3 treatments compared to having to attend 36 sessions are expected to have higher compliance.

 

Talk nerdy to me

While the study was conducted in a specialized care setting with experienced physiotherapists, the findings suggest that adding rESWT, sham-rESWT, or a standardized exercise program to advice and custom orthoses does not provide additional benefits. This implies that primary care providers might not need to prioritize these interventions over basic advice and orthoses when treating plantar fasciopathy.

The study’s rigorous design, including blinding and randomization, strengthens its findings. However, the high compliance rate in the exercise group and the possible influence of previous treatments and patients’ beliefs about receiving real rESWT highlight the complexity of managing plantar fasciopathy.

The study contributes to the understanding of plantar fasciopathy management, emphasizing the limited additional benefit of rESWT and structured exercise programs over standard care with advice and customized orthoses. Future research should explore optimizing the content and delivery of advice, the effectiveness of different orthoses types, and the natural course of the condition with “wait and see” approaches.

 

Take-home messages

For treating plantar fasciopathy, rESWT, sham-rESWT, or a standardized exercise program in combination with advice and customized foot orthoses does not significantly improve heel pain compared to advice and customized foot orthoses alone. These findings support focusing on standardized advice and orthoses as the primary treatment approach in clinical practice.

 

Reference

Heide M, Røe C, Mørk M, Myhre K, Brunborg C, Brox JI, Hoksrud AF. Is radial extracorporeal shock wave therapy (rESWT), sham-rESWT or a standardised exercise programme in combination with advice plus customised foot orthoses more effective than advice plus customised foot orthoses alone in the treatment of plantar fasciopathy? A double-blind, randomised, sham-controlled trial. Br J Sports Med. 2024 Jun 20:bjsports-2024-108139. doi: 10.1136/bjsports-2024-108139. Epub ahead of print. PMID: 38904119. 

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