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

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ClinicalTrials.gov Identifier: NCT04385329
Recruitment Status : Completed
First Posted : May 12, 2020
Last Update Posted : May 12, 2020
Sponsor:
Information provided by (Responsible Party):
Ettore Carlis, Foundation IRCCS San Matteo Hospital

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.

Condition or disease Intervention/treatment Phase
Tendinopathy Other: Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points Other: Shock wave therapy on plantar fascia only Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Shock Wave Therapy for Sural Myofascial Pain Syndrome Associated With Plantar Fasciitis: a Pilot Randomized Controlled Trial
Actual Study Start Date : July 4, 2016
Actual Primary Completion Date : July 4, 2018
Actual Study Completion Date : November 3, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental group:shock waves extended to gastrocnemius TrP
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
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.

Active Comparator: Control group: shock waves not extended to gastrocnemius TrP
A standard focused shock wave therapy exclusively targeted at the plantar fascia
Other: 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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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Responsible Party: Ettore Carlis, Physician specialised in physical medicine and rehabilitation, Foundation IRCCS San Matteo Hospital
ClinicalTrials.gov Identifier: NCT04385329    
Other Study ID Numbers: 20160017179
First Posted: May 12, 2020    Key Record Dates
Last Update Posted: May 12, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ettore Carlis, Foundation IRCCS San Matteo Hospital:
Myofascial pain syndrome
Additional relevant MeSH terms:
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Tendinopathy
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries