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

Tendinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385329
• Other study ID #: 20160017179
• Status: Completed
• Phase: N/A
• Start date: July 4, 2016
• Est. completion date: November 3, 2018

Study information

• Verified date: May 2020
• Source: Foundation IRCCS San Matteo Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 3, 2018
• Est. primary completion date: July 4, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Myofascial Pain Syndromes
• Tendinopathy

Intervention

Other:
• Shock 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.
• Shock 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Foundation IRCCS San Matteo Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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