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

Not Applicable

Completed

• Conditions: Fasciitis, Plantar
• Interventions: Device: Focused shock wave; Dietary Supplement: Tendisulfur Pro

• Registration Number: NCT04664712
• Lead Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

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.

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 Timeline

• Study Start: 2019-09-11
• Primary Completion: 2020-05-01
• Status Verified: 2020-11
• Study Completion: 2020-11-20
• Study First Submitted: 2020-11-25
• Study First Submitted QC: 2020-12-07
• Last Update Submitted: 2020-12-07
• Study First Posted: 2020-12-11
• Last Update Posted: 2020-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
shock wave	Focused shock wave	-
shock wave and tendon supplement	Focused shock wave	-
shock wave and tendon supplement	Tendisulfur Pro	-

Primary Outcome Measures

Name	Time	Method
Change in Visual Analogue Score (VAS)	T1 (three months); T2 (six months)	The pain was quantified using the VAS scale with the scores ranging between 0 (no pain)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia; 🇮🇹 Bari, Italy