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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

Tracking Information
First Submitted Date  ICMJE May 5, 2020
First Posted Date  ICMJE May 12, 2020
Last Update Posted Date May 12, 2020
Actual Study Start Date  ICMJE July 4, 2016
Actual Primary Completion Date July 4, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 11, 2020)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2020)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Shock Wave Therapy for Sural Myofascial Pain Associated to Chronic Heel Pain
Official Title  ICMJE Shock Wave Therapy for Sural Myofascial Pain Syndrome Associated With Plantar Fasciitis: a Pilot Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tendinopathy
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points
  • Active Comparator: Control group: shock waves not extended to gastrocnemius TrP
    A standard focused shock wave therapy exclusively targeted at the plantar fascia
    Intervention: Other: Shock wave therapy on plantar fascia only
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 11, 2020)
55
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 3, 2018
Actual Primary Completion Date July 4, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04385329
Other Study ID Numbers  ICMJE 20160017179
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ettore Carlis, Foundation IRCCS San Matteo Hospital
Study Sponsor  ICMJE Foundation IRCCS San Matteo Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Foundation IRCCS San Matteo Hospital
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP