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

NCT05925777 | Completed

• 1 other identifier: THEAL-fasc
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Fasciitis, Plantar

Keywords

laser; foot; ankle; pain

Outcome Measures

Primary Outcomes (2)

• 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."

  change between baseline to 2 months

• 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."

  change between baseline to 6 months

Secondary Outcomes (4)

• functional recovery

  change between baseline to 2 months

• functional recovery

  change between baseline to 6 months

• perception of clinical improvement

  change between baseline to 2 months

• perception of clinical improvement

  change between baseline to 6 months

Other Outcomes (4)

• band thickness

  change between baseline to 2 months

• band thickness

  change between baseline to 6 months

• presence of edema

  change between baseline to 2 months

Study Arms (2)

experimental group

EXPERIMENTAL

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 exercise like those of the control group.

Device: THEAL (Mectronic, Bergamo)

Control group

NO INTERVENTION

Patients will perform four daily stretching exercises (three sets of 30 seconds), for 6 weeks. 1. Hamstring and ankle plantar flexor stretch (straight leg raise in supine position) 2. 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.

Interventions

THEAL (Mectronic, Bergamo) DEVICE

laser therapy high intensity

Also known as: laser

experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

Study Sites (1)

Angela Notarnicola

Bari, 70124, Italy

Location

Related Publications (1)

• 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.

  PMID: 12851352 BACKGROUND

MeSH Terms

Conditions

Fasciitis, Plantar; Pain

Interventions

Lasers

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomized prospective

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 29, 2023
• Study Start: August 1, 2023
• Primary Completion: January 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)