Efficacy of Focused Shock Waves Combined With Adjuvant Therapy With Tendon Supplement

NCT04664712 | Completed

• 1 other identifier: ESWT-TP
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Physical treatment with focused shock waves is effective in the treatment of tendonitis. Food supplements could facilitate the healing of tendinopathies when combined with shock wave therapy.

Conditions

Fasciitis, Plantar

Keywords

focused shock waves; tendinitis; natriuretics

Outcome Measures

Primary Outcomes (2)

• Change in Visual Analogue Score (VAS)

  The pain was quantified using the VAS scale with the scores ranging between 0 (no pain) and 10 (worst imaginable pain).

  T0 (recruitment); T1 (three months)

• Change in Visual Analogue Score (VAS)

  The pain was quantified using the VAS scale with the scores ranging between 0 (no pain)

  T1 (three months); T2 (six months)

Secondary Outcomes (4)

• Change in American Foot & Ankle Score (AOFAS)

  T0 (recruitment); T2 (six months)

• Change in Foot Function Index (FFI)

  T0 (recruitment); T2 (six months)

• Roles & Maudsley (R&M)

  T1 (three months)

• Roles & Maudsley (R&M)

  T2 (six months)

Study Arms (2)

shock wave

ACTIVE COMPARATOR

Device: Focused shock wave

shock wave and tendon supplement

ACTIVE COMPARATOR

Dietary Supplement: Tendisulfur Pro; Device: Focused shock wave

Interventions

Tendisulfur Pro DIETARY_SUPPLEMENT

Dietary supplement based on Methylsulfonylmethane (2.5 g), hydrolyzed collagen (1 g), L-arginine (1 g), L-lysine (500 mg), Vitamin C (500 mg), Bromelain (200 mg), Chondroitin sulfate (150 mg), Glucosamine (150 mg) \[17, 18\], dry extracts of turmeric (100 mg), Boswellia (100 mg) and Myrrh (50 mg)

shock wave and tendon supplement

Focused shock wave DEVICE

We delivered 2000 shots per session using a low/medium energy level (range between 0.01 and 0.175 milliJoule/mm2) depending on the patient's tolerance during treatment with a frequency of 4 Hz.

shock wave; shock wave and tendon supplement

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• plantar heel pain diagnosed clinically and instrumentally (ultrasound) as plantar fasciitis, that has not responded to conservative treatment for at least six months;

You may not qualify if:

• History of previous fractures or ankle and heel surgery;
• Recurrence of previous local painful episodes;
• Lesion of the plantar fascia on US examination;
• Presence of pathologies that affect the function of the foot (lumbar radiculopathy, Achilles tendinitis, Morton's neuroma, etc.);
• Chronic inflammatory conditions such as psoriasis, psoriatic arthritis, spondyloarthritis, ankylosing spondylitis, rheumatoid arthritis, chronic inflammatory bowel disease.

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari: lead

Study Sites (1)

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Bari, 70124, Italy

Location

MeSH Terms

Conditions

Fasciitis, Plantar; Tendinopathy

Condition Hierarchy (Ancestors)

Fasciitis; Musculoskeletal Diseases; Foot Diseases; Muscular Diseases; Tendon Injuries; Wounds and Injuries

Study Officials

• Biagio Moretti, Prof

  University of Bari Aldo Moro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2020
• First Posted: December 11, 2020
• Study Start: September 11, 2019
• Primary Completion: May 1, 2020
• Study Completion: November 20, 2020
• Last Updated: December 11, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)