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

NCT ID: NCT04664712

Last Updated: 2020-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-11

Study Completion Date

2020-11-20

Brief Summary

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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

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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).

Conditions

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Fasciitis, Plantar

Keywords

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focused shock waves tendinitis natriuretics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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shock wave

Group Type ACTIVE_COMPARATOR

Focused shock wave

Intervention Type 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 and tendon supplement

Group Type ACTIVE_COMPARATOR

Tendisulfur Pro

Intervention Type 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)

Focused shock wave

Intervention Type 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.

Interventions

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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)

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Biagio Moretti, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Bari Aldo Moro

Locations

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AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Bari, , Italy

Site Status

Countries

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Italy

Other Identifiers

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ESWT-TP

Identifier Type: -

Identifier Source: org_study_id