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

NCT04385329 | Completed

• 1 other identifier: 20160017179
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tendinopathy

Keywords

Myofascial pain syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in PPT-pressure pain threshold

  PPT was recorded at baseline, at two months time point and at three months time point

Study Arms (2)

Experimental group:shock waves extended to gastrocnemius TrP

EXPERIMENTAL

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

Control group: shock waves not extended to gastrocnemius TrP

ACTIVE COMPARATOR

A standard focused shock wave therapy exclusively targeted at the plantar fascia

Other: Shock wave therapy on plantar fascia only

Interventions

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.

Experimental group:shock waves extended to gastrocnemius TrP

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.

Control group: shock waves not extended to gastrocnemius TrP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

MeSH Terms

Conditions

Tendinopathy; Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Tendon Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician specialised in physical medicine and rehabilitation

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 12, 2020
• Study Start: July 4, 2016
• Primary Completion: July 4, 2018
• Study Completion: November 3, 2018
• Last Updated: May 12, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share