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Completed

NCT Number: NCT04664712

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

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.

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Key information

Conditions

Fasciitis, Plantar Fasciitis Foot Diseases Muscular Diseases Musculoskeletal Diseases Tendinopathy Tendon Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia

Bari, 70124, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tendisulfur Pro

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

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.

Primary outcomes

  1. Change in Visual Analogue Score (VAS)

    Time frame: T0 (recruitment); T1 (three months)

    The pain was quantified using the VAS scale with the scores ranging between 0 (no pain) and 10 (worst imaginable pain).

  2. Change in Visual Analogue Score (VAS)

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

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

Secondary outcomes

  1. Change in American Foot & Ankle Score (AOFAS)

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

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

  2. Change in Foot Function Index (FFI)

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

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

  3. Roles & Maudsley (R&M)

    Time frame: T1 (three months)

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

  4. Roles & Maudsley (R&M)

    Time frame: T2 (six months)

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

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2020
Registry last updated
Dec 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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