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Clinical Trials/NCT04385329
NCT04385329
Completed
Not Applicable

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

Fondazione IRCCS Policlinico San Matteo di Pavia0 sites55 target enrollmentJuly 4, 2016
ConditionsTendinopathy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Tendinopathy
Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Enrollment
55
Primary Endpoint
Change in FFI-foot function index
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 4, 2016
End Date
November 3, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Fondazione IRCCS Policlinico San Matteo di Pavia
Responsible Party
Principal Investigator
Principal Investigator

Ettore Carlis

Physician specialised in physical medicine and rehabilitation

Fondazione IRCCS Policlinico San Matteo di Pavia

Eligibility Criteria

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

Outcomes

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

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