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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04385329
Enrollment
55
Registered
2020-05-12
Start date
2016-07-04
Completion date
2018-11-03
Last updated
2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tendinopathy

Keywords

Myofascial pain syndrome

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.

Interventions

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

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.

OTHERShock wave therapy on plantar fascia only

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.

Sponsors

Fondazione IRCCS Policlinico San Matteo di Pavia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in FFI-foot function indexFFI was administered at baseline, at two months time point and at three months time pointFoot 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

MeasureTime frameDescription
Change in PPT-pressure pain thresholdPPT was recorded at baseline, at two months time point and at three months time pointPressure 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026