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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tendinopathy Muscular Diseases Musculoskeletal Diseases Myofascial Pain Syndromes Tendon Injuries Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points

Other

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.

Shock wave therapy on plantar fascia only

Other

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.

Primary outcomes

Change in FFI-foot function index

Time frame: 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 outcomes

Change in PPT-pressure pain threshold

Time frame: 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

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

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

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: May 12, 2020
Registry last updated: May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed