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

Efficacy of Focused Shock Waves Combined With Adjuvant Therapy With Tendon Supplement in the Treatment of Plantar Fasciitis: a Prospective Randomized Study

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.

Study Overview

• Status: Completed
• Conditions: Fasciitis, Plantar
• Intervention / Treatment: Device: Focused shock wave; Dietary supplement: Tendisulfur Pro

Detailed Description

A single-blind, randomized prospective study (level of evidence IB) was designed. Patients with plantar fasciitis were recruited and randomized to group A and group B. Group A was treated with focused shock waves alone and group B with a combination of focused shock waves and tendon supplement. Pain remission (primary endpoint) and functional recovery (secondary endpoint) are monitored in both groups at three time points (Months 0, 3, and 6).

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Bari, Italy, 70124
    • AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: shock wave	Device: Focused shock wave; 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.
ACTIVE_COMPARATOR: shock wave and tendon supplement	Device: Focused shock wave; 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.; Dietary supplement: Tendisulfur Pro; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in American Foot & Ankle Score (AOFAS)	The scores ranging between 100 (no disability) and 0 (maximum disability)	T0 (recruitment); T2 (six months)
Change in Foot Function Index (FFI)	The scores ranging between 100 (no disability) and 0 (maximum disability).	T0 (recruitment); T2 (six months)
Roles & Maudsley (R&M)	Monitorization of the patient's perception of improvement, with the scores ranging from 1 (excellent) to 4 (minimum).	T1 (three months)
Roles & Maudsley (R&M)	Monitorization of the patient's perception of improvement, with the scores ranging from 1 (excellent) to 4 (minimum).	T2 (six months)

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
• Investigators: Principal Investigator: Biagio Moretti, Prof, University of Bari Aldo Moro

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 11, 2019
• Primary Completion (ACTUAL): May 1, 2020
• Study Completion (ACTUAL): November 20, 2020

Study Registration Dates

• First Submitted: November 25, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (ACTUAL): December 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: tendinitis; focused shock waves; natriuretics
• Additional Relevant MeSH Terms: Foot Diseases; Musculoskeletal Diseases; Fasciitis; Fasciitis, Plantar
• Other Study ID Numbers: ESWT-TP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No sharing

Drug and device information, study documents

• 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