Repetitive low-energy shock wave application without local anesthesia is more efficient than repetitive low-energy shock wave application with local anesthesia in the treatment of chronic plantar fasciitis
Introduction
Plantar heel pain, commonly referred to as insertional plantar fasciitis, is a common condition among athletes as well as the general population. The characteristic complaints are knife-like pain at the calcaneal insertion of the medial part of the plantar fascia, typically worse on first arising in the morning, and often lasting months to years. Many treatment regimens exist but effectiveness is variable [8], [52], [55], [63]. Multiple publications focused on the evaluation of a clinically relevant effect of shock wave application on plantar heel pain, either of high-energy extracorporeal shock wave treatment (ESWT), applied in a single session with local or regional anesthesia [3], [6], [9], [28], [35], [36], [38], [59] or of low-energy ESWT, applied repetitively without local anesthesia [1], [4], [7], [11], [20], [21], [22], [23], [27], [44], [45], [46], [48], [51].
A shock wave is defined as an acoustic wave at the front of which pressure rises from the ambient value to its maximum within a few nanoseconds. Typical characteristics are a high peak-pressure amplitude with a rise time of nanosecond duration, a short lifecycle of microsecond duration, and a frequency spectrum ranging from the audible to the far ultrasonic level. A recently published multicenter trial [16] failed to show effectiveness of repetitive low-energy ESWT compared to placebo ESWT in patients with a recalcitrant plantar fasciitis. In this trial a local anesthesia was used to secure blinding of the patients. However, other authors pointed at flaws in the study design such as use of simultaneous local anesthesia [4], [12], [34], [47]. In an Austrian pilot study [4], 6 weeks after repetitive low-energy ESWT without local anesthesia 60% of cases achieved ⩾50% reduction of pain compared to 29% when identical ESWT was applied under local anesthesia.
This preliminary report provided new important aspects in the use of local anesthesia which needed to be confirmed in a prospective randomized controlled trial.
Section snippets
Patients and methods
The objective of the study was to evaluate the influence of local anesthesia (LA) on the efficiency of repetitive low-energy ESWT for patients with a chronic plantar fasciitis. The study was designed as a randomized, single-center, parallel treatment study with a blinded independent observer. The trial was approved by the hospital’s review board.
Primary outcome measure
The primary efficacy endpoint was defined as reduction of pain from baseline to month 3 post-treatment in the pain numeric rating scale (NRS) during first steps in the morning. The average pain score for patients who received ESWT without local anesthesia (Group I) was 6.9 ± 1.2 points at baseline, and 2.2 ± 2.0 points at 3 months. The average pain score for patients who received ESWT with local anesthesia (Group II) was 6.7 ± 1.1 points at baseline, and 4.1 ± 1.5 points at 3 months. The mean
Discussion
Recently repetitive low-energy extracorporeal shock wave treatment (ESWT) has been widely used to treat a number of musculoskeletal conditions, including insertional disorders such as plantar fasciitis.
In clinical practice, the application of a local anesthesia prior to low-energy ESWT became subject to criticism [4], [12], [47], therefore calling in question the negative results of a multicenter trial [16] on ESWT in patients suffering from chronic plantar fasciitis. In this trial local
Conclusions
We conclude that there is a positive treatment effect of repetitive low-energy ESWT as applied at 3-month follow-up in subjects with chronic plantar fasciitis. This positive treatment effect may be reduced by application of a local anesthetic to the painful area prior to low-energy ESWT. Until further experimental and clinical research has developed evidence for this effect, a local anesthetic should not be used for blinding in randomized-controlled trials evaluating the clinical efficacy of
Acknowledgement
No research or institutional support has been received for the conduction of this trial.
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