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

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari44 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Fasciitis, Plantar

Interventions

Tendisulfur ProDIETARY_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)

Focused shock waveDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Bari, Italy

Outcomes

Primary Outcomes

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).

Time frame: 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)

Time frame: T1 (three months); T2 (six months)

Secondary Outcomes

Change in American Foot & Ankle Score (AOFAS)

The scores ranging between 100 (no disability) and 0 (maximum disability)

Time frame: T0 (recruitment); T2 (six months)

Change in Foot Function Index (FFI)

The scores ranging between 100 (no disability) and 0 (maximum disability).

Time frame: 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).

Time frame: 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).

Time frame: T2 (six months)

Data from ClinicalTrials.gov

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