search
Back to results

Plantar Fasciitis Treatment: Influence of the Possible Presence of Subchondral Bone Edema (THEAL-F)

Primary Purpose

Fasciitis, Plantar

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
THEAL (Mectronic, Bergamo)
Sponsored by
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fasciitis, Plantar focused on measuring laser, foot, ankle, pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: history of heel pain for at least 3 months prior to enrollment, Pain on palpation of the medial calcaneal tubercle or proximal plantar fascia, plantar fascia thickness of 4.0 mm or greater. Exclusion Criteria: age below 18 years of age history of systemic disease pregnancy Previous surgery on the lower limbs diagnosis of fibromyalgia, neurological disease, Achilles tendinopathy, metatarsalgia, acute ankle sprain, tarsal tunnel syndrome, or heel joint syndrome body mass index (BMI) greater than 35 kg/m2 wounds, infections in the treatment area altered sensation in the treatment area skin pigmentation alterations in the area to be treated (tattoo, dyschromia) metal implants in the treatment area History of oral or injected corticosteroid therapy within the past six weeks Diagnosis of neurological heel pain (radiculopathy) diagnosis of systemic inflammatory arthritis (rheumatoid arthritis, etc.) other acute pathologies (febrile fever, cold, etc.) requiring treatment other painful conditions requiring painkillers (toothache, back pain, etc.) neoplasms cardiac pacemaker or other device.

Sites / Locations

  • Angela NotarnicolaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

experimental group

Control group

Arm Description

The protocol provides for the administration of 10 polymodal high energy laser therapy sessions, to be carried out every other day. The THEAL device (Mectronic, Bergamo) allows to deliver 4 wavelengths (650 nm, 810 nm, 980 nm and 1064 nm), with continuous and pulsed mode, with power up to 20 W. Patients will perform stretching exercises like those of the control group.

Patients will perform four daily stretching exercises (three sets of 30 seconds), for 6 weeks. Hamstring and ankle plantar flexor stretch (straight leg raise in supine position) self-stretching of the surae muscles: the patient bends forward in a standing position with the affected foot farthest from the wall, keeping the heel on the floor; 3. the soleus muscle is exercised with the knee flexed and the gastrocnemius muscle with the knee extended 4. Plantar fascia self-stretch: In a seated position, the patient crosses the affected foot over the contralateral thigh and passively extends the metatarsophalangeal joints . In the first session, the volunteers will be trained on how to perform the exercises correctly and will be monitored once a week.

Outcomes

Primary Outcome Measures

recovery of pain
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
recovery of pain
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."

Secondary Outcome Measures

functional recovery
The Foot Function Index (FFI) measures the effect of foot problems on function in terms of pain and disability.The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present. The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present.
functional recovery
The Foot Function Index (FFI) measures the effect of foot problems on function in terms of pain and disability.The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present. The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present.
perception of clinical improvement
Maudsley and Roles scale scores range from 0-4 points for excellent to poor
perception of clinical improvement
Maudsley and Roles scale scores range from 0-4 points for excellent to poor

Full Information

First Posted
June 13, 2023
Last Updated
September 1, 2023
Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
search

1. Study Identification

Unique Protocol Identification Number
NCT05925777
Brief Title
Plantar Fasciitis Treatment: Influence of the Possible Presence of Subchondral Bone Edema
Acronym
THEAL-F
Official Title
Plantar Fasciitis Treatment: Influence of the Possible Presence of Subchondral Bone Edema
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2023 (Actual)
Primary Completion Date
July 1, 2026 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Standard treatments of plantar fasciitis include stretching exercises of the posterior muscle chain and plantar fascia, taking anti-inflammatories, cortisone infiltration or biostimulation with physical therapies (low energy laser therapy, shock waves, ultrasound therapy, etc.). In non-responsive forms to conservative treatments, surgical treatment can be undertaken. Laser therapy is indicated for plantar fasciitis, in particular for its biological anti-inflammatory, anti-edema and reparative effects on the plantar fascia; to date, the potential effects also on the underlying bone edema component, when present, which aggravates and self-maintains the ongoing pathology are not known.
Detailed Description
Plantar fasciitis is one of the most common causes of heel pain; the pain is more intense in the morning, tends to decrease during the day with movement, to flare up after sitting for a long time. It presents itself as inflammation and contextual degeneration of the insertion of the fascia that covers the muscles present at the level of the sole of the foot, with progressive evolution and possible calcification of the insertion. The incidence is between 9 and 20% of the population, with a higher incidence in middle-aged obese women and in young male runners. The diagnosis makes use of radiography, to verify any local deformities or the presence of the subcalcaneal spur, and ultrasound, to investigate the integrity of the fascia and its thickening. MRI images are useful for better studying the heel bone and plantar fascia, especially for discerning other various causes of heel pain, including stress fractures, tarsal tunnel syndrome, and Achilles tendinopathy. Signal changes with bone edema are sometimes found in association with plantar fasciitis and may be indicative of or represent the result of avulsive trauma, stress, intraspongious fractures or a combination of these situations. These MRI images are similar to those described in the elbow in some patients with epicondylitis, where overuse can cause increased bone edema on T2-weights. Previous studies have shown the presence of bone edema at the level of the heel on MRI in 35% of patients with plantar fasciitis. Plantar fascia evaluation with a dedicated magnetic resonance scanner in weight-bearing position: our experience in patients with plantar fasciitis and in healthy volunteers. Maier et al demonstrated that the presence of calcaneal bone edema is a highly predictive factor for improved response to shock wave treatment. Often the finding of a thickening of the fascia and the signal changes of the soft tissues do not correlate with the clinical response, while the presence of bone edema is highly predictive (positive predictive value 0.94, sensitivity 0.89, specificity 0.8).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasciitis, Plantar
Keywords
laser, foot, ankle, pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized prospective
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
experimental group
Arm Type
Experimental
Arm Description
The protocol provides for the administration of 10 polymodal high energy laser therapy sessions, to be carried out every other day. The THEAL device (Mectronic, Bergamo) allows to deliver 4 wavelengths (650 nm, 810 nm, 980 nm and 1064 nm), with continuous and pulsed mode, with power up to 20 W. Patients will perform stretching exercises like those of the control group.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will perform four daily stretching exercises (three sets of 30 seconds), for 6 weeks. Hamstring and ankle plantar flexor stretch (straight leg raise in supine position) self-stretching of the surae muscles: the patient bends forward in a standing position with the affected foot farthest from the wall, keeping the heel on the floor; 3. the soleus muscle is exercised with the knee flexed and the gastrocnemius muscle with the knee extended 4. Plantar fascia self-stretch: In a seated position, the patient crosses the affected foot over the contralateral thigh and passively extends the metatarsophalangeal joints . In the first session, the volunteers will be trained on how to perform the exercises correctly and will be monitored once a week.
Intervention Type
Device
Intervention Name(s)
THEAL (Mectronic, Bergamo)
Other Intervention Name(s)
laser
Intervention Description
laser therapy high intensity
Primary Outcome Measure Information:
Title
recovery of pain
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time Frame
change between baseline to 2 months
Title
recovery of pain
Description
The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Time Frame
change between baseline to 6 months
Secondary Outcome Measure Information:
Title
functional recovery
Description
The Foot Function Index (FFI) measures the effect of foot problems on function in terms of pain and disability.The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present. The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present.
Time Frame
change between baseline to 2 months
Title
functional recovery
Description
The Foot Function Index (FFI) measures the effect of foot problems on function in terms of pain and disability.The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present. The scores range from 0 to 100; the higher the score, the more limitation/pain/disability is present.
Time Frame
change between baseline to 6 months
Title
perception of clinical improvement
Description
Maudsley and Roles scale scores range from 0-4 points for excellent to poor
Time Frame
change between baseline to 2 months
Title
perception of clinical improvement
Description
Maudsley and Roles scale scores range from 0-4 points for excellent to poor
Time Frame
change between baseline to 6 months
Other Pre-specified Outcome Measures:
Title
band thickness
Description
ultrasound image to measure of fascia thickness, measured in mm
Time Frame
change between baseline to 2 months
Title
band thickness
Description
ultrasound image to measure of fascia thickness, measured in mm
Time Frame
change between baseline to 6 months
Title
presence of edema
Description
MRI image to verify the presence or absence of bone edema (dichotomous answer)
Time Frame
change between baseline to 2 months
Title
presence of edema
Description
MRI image to verify the presence of absence or bone edema (dichotomous answer)
Time Frame
change between baseline to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: history of heel pain for at least 3 months prior to enrollment, Pain on palpation of the medial calcaneal tubercle or proximal plantar fascia, plantar fascia thickness of 4.0 mm or greater. Exclusion Criteria: age below 18 years of age history of systemic disease pregnancy Previous surgery on the lower limbs diagnosis of fibromyalgia, neurological disease, Achilles tendinopathy, metatarsalgia, acute ankle sprain, tarsal tunnel syndrome, or heel joint syndrome body mass index (BMI) greater than 35 kg/m2 wounds, infections in the treatment area altered sensation in the treatment area skin pigmentation alterations in the area to be treated (tattoo, dyschromia) metal implants in the treatment area History of oral or injected corticosteroid therapy within the past six weeks Diagnosis of neurological heel pain (radiculopathy) diagnosis of systemic inflammatory arthritis (rheumatoid arthritis, etc.) other acute pathologies (febrile fever, cold, etc.) requiring treatment other painful conditions requiring painkillers (toothache, back pain, etc.) neoplasms cardiac pacemaker or other device.
Facility Information:
Facility Name
Angela Notarnicola
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Notarnicola
Phone
0805592938
Email
angelanotarnicola@yahoo.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
12851352
Citation
DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013.
Results Reference
background

Learn more about this trial

Plantar Fasciitis Treatment: Influence of the Possible Presence of Subchondral Bone Edema

We'll reach out to this number within 24 hrs