Shock Wave Therapy for Sural Myofascial Pain Associated to Chronic Heel Pain

Study Overview
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Brief Summary
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The aim of this randomized controlled study in to investigate if a shock wave treatment extended to the gastrocnemius-soleus trigger points (TrP) is more effective than a standard treatment exclusively targeted at the plantar fascia in a population affected by unilateral plantar fasciitis with concomitant sural myofascial pain syndrome.

Official Title
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Shock Wave Therapy for Sural Myofascial Pain Syndrome Associated With Plantar Fasciitis: a Pilot Randomized Controlled Trial

Conditions
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Tendinopathy

Intervention / Treatment
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* Other: Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points
* Other: Shock wave therapy on plantar fascia only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult age (18 to 75 years) and written informed consent; Unilateral heel pain of four weeks or longer duration; Pain to digital pressure in the insertional area of the plantar fascia at the calcaneum; Sonographic examination showing a plantar fascia thickness greater than 3.8mm (see procedures for details); Concomitant presence of a sural myofascial pain syndrome (SMPS), diagnosed on the basis of the finding, at the physical examination, of trigger points of the gastrocnemius-soleus muscle complex, according to Travel and Simons' original description. Exclusion Criteria: No corticosteroid injections or other physical therapies since the onset of the current pain episode (except pharmacological pain treatments and foot orthoses); No general contraindication to shock wave therapy (pregnancy, bleeding disorders or anticoagulant drug usage, cancer in the focal area); No clinical signs of lumbar radiculopathy at physical examination; No ankle osteoarthritis, diagnosed on the basis of clinical and radiographic findings; No previous fractures or surgery in the affected ankle and foot; No rheumatologic diseases, no plantar fibromatosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group:shock waves extended to gastrocnemius TrP<br>Focused shock wave therapy was extended from the plantar fascia to the gastrocnemius-soleus trigger points. | Other: Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points<br>* Enrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia and the gastrocnemius-soleus trigger points were clinically targeted and treated with a perpendicular technique.<br>|
| Active Comparator: Control group: shock waves not extended to gastrocnemius TrP<br>A standard focused shock wave therapy exclusively targeted at the plantar fascia | Other: Shock wave therapy on plantar fascia only<br>* Enrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia was clinically targeted and treated with a perpendicular technique.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in FFI-foot function index | Foot Function Index is self-administered questionnaire designed to measure foot performances in relation to symptoms. Foot Function Index is structured in two sections of nine items each, investigating foot pain (FFI-A) and function (FFI-B) respectively. The total score of each section ranges from zero (no pain/no functional limitation) to 100 (intolerable pain/complete inability). The two scores were separately analysed. | FFI was administered at baseline, at two months time point and at three months time point | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PPT-pressure pain threshold | Pressure pain threshold (PPT) of the gastrocnemius-soleus trigger points was assessed by means of a digital hand-held algometer (see procedures for details). PPT is the minimal force that induces pain and its measurement is useful to quantitatively evaluate the effect of a treatment on trigger points | PPT was recorded at baseline, at two months time point and at three months time point | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myofascial pain syndrome