Back to resultsShock Wave Therapy for Sural Myofascial Pain Associated to Chronic Heel Pain
Primary Purpose
Tendinopathy
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points
Shock wave therapy on plantar fascia only
Sponsored by
About this trial
This is an interventional treatment trial for Tendinopathy focused on measuring Myofascial pain syndrome
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group:shock waves extended to gastrocnemius TrP
Control group: shock waves not extended to gastrocnemius TrP
Arm Description
Focused shock wave therapy was extended from the plantar fascia to the gastrocnemius-soleus trigger points.
A standard focused shock wave therapy exclusively targeted at the plantar fascia
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT04385329
First Posted
May 5, 2020
Last Updated
May 11, 2020
Sponsor
Foundation IRCCS San Matteo Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04385329
Brief Title
Shock Wave Therapy for Sural Myofascial Pain Associated to Chronic Heel Pain
Official Title
Shock Wave Therapy for Sural Myofascial Pain Syndrome Associated With Plantar Fasciitis: a Pilot Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 4, 2016 (Actual)
Primary Completion Date
July 4, 2018 (Actual)
Study Completion Date
November 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Foundation IRCCS San Matteo Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy
Keywords
Myofascial pain syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental group:shock waves extended to gastrocnemius TrP
Arm Type
Experimental
Arm Description
Focused shock wave therapy was extended from the plantar fascia to the gastrocnemius-soleus trigger points.
Arm Title
Control group: shock waves not extended to gastrocnemius TrP
Arm Type
Active Comparator
Arm Description
A standard focused shock wave therapy exclusively targeted at the plantar fascia
Intervention Type
Other
Intervention Name(s)
Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Shock wave therapy on plantar fascia only
Intervention Description
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 Measure Information:
Title
Change in FFI-foot function index
Description
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.
Time Frame
FFI was administered at baseline, at two months time point and at three months time point
Secondary Outcome Measure Information:
Title
Change in PPT-pressure pain threshold
Description
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
Time Frame
PPT was recorded at baseline, at two months time point and at three months time point
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Shock Wave Therapy for Sural Myofascial Pain Associated to Chronic Heel Pain
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