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

Primary Purpose

Fasciitis, Plantar

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

Tendisulfur Pro

Focused shock wave

About this trial

This is an interventional treatment trial for Fasciitis, Plantar focused on measuring focused shock waves, tendinitis, natriuretics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

shock wave

shock wave and tendon supplement

Arm Description

Outcomes

Primary Outcome Measures

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).

Change in Visual Analogue Score (VAS)

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

Secondary Outcome Measures

Change in American Foot & Ankle Score (AOFAS)

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

Change in Foot Function Index (FFI)

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

Roles & Maudsley (R&M)

Monitorization of the patient's perception of improvement, with the scores ranging from 1 (excellent) to 4 (minimum).

Roles & Maudsley (R&M)

Monitorization of the patient's perception of improvement, with the scores ranging from 1 (excellent) to 4 (minimum).

Full Information

NCT ID

NCT04664712

First Posted

November 25, 2020

Last Updated

December 7, 2020

Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

1. Study Identification

Unique Protocol Identification Number

NCT04664712

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

September 11, 2019 (Actual)

Primary Completion Date

May 1, 2020 (Actual)

Study Completion Date

November 20, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fasciitis, Plantar

Keywords

focused shock waves, tendinitis, natriuretics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

shock wave

Arm Type

Active Comparator

Arm Title

shock wave and tendon supplement

Arm Type

Active Comparator

Intervention Type

Dietary Supplement

Intervention Name(s)

Tendisulfur Pro

Intervention Description

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)

Intervention Type

Device

Intervention Name(s)

Focused shock wave

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in Visual Analogue Score (VAS)

Description

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)

Title

Change in Visual Analogue Score (VAS)

Description

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 Outcome Measure Information:

Title

Change in American Foot & Ankle Score (AOFAS)

Description

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

Time Frame

T0 (recruitment); T2 (six months)

Title

Change in Foot Function Index (FFI)

Description

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

Time Frame

T0 (recruitment); T2 (six months)

Title

Roles & Maudsley (R&M)

Description

Monitorization of the patient's perception of improvement, with the scores ranging from 1 (excellent) to 4 (minimum).

Time Frame

T1 (three months)

Title

Roles & Maudsley (R&M)

Description

Monitorization of the patient's perception of improvement, with the scores ranging from 1 (excellent) to 4 (minimum).

Time Frame

T2 (six months)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Biagio Moretti, Prof

Organizational Affiliation

University of Bari Aldo Moro

Official's Role

Principal Investigator

Facility Information:

Facility Name

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

City

Bari

ZIP/Postal Code

70124

Country

Italy

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No sharing

Learn more about this trial

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

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