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

Not Applicable

Completed

• Conditions: Tendinopathy
• Interventions: Other: Shock wave therapy on plantar fascia only; Other: Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points

• Registration Number: NCT04385329
• Lead Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-04
• Primary Completion: 2018-07-04
• Study Completion: 2018-11-03
• Status Verified: 2020-05
• Study First Submitted: 2020-05-05
• Study First Submitted QC: 2020-05-11
• Last Update Submitted: 2020-05-11
• Study First Posted: 2020-05-12
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group: shock waves not extended to gastrocnemius TrP	Shock wave therapy on plantar fascia only	A standard focused shock wave therapy exclusively targeted at the plantar fascia
Experimental group:shock waves extended to gastrocnemius TrP	Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points	Focused shock wave therapy was extended from the plantar fascia to the gastrocnemius-soleus trigger points.

Primary Outcome Measures

Name	Time	Method
Change in FFI-foot function index	FFI was administered at baseline, at two months time point and at three months time point	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.

Secondary Outcome Measures

Name	Time	Method
Change in PPT-pressure pain threshold	PPT was recorded at baseline, at two months time point and at three months time point	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