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

A

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Status

Completed

Conditions

Fasciitis, Plantar

Treatments

Dietary Supplement: Tendisulfur Pro
Device: Focused shock wave

Study type

Interventional

Funder types

Other

Identifiers

NCT04664712
ESWT-TP

Details and patient eligibility

About

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.

Full 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).

Enrollment

44 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

shock wave
Active Comparator group
Treatment:
Device: Focused shock wave
shock wave and tendon supplement
Active Comparator group
Treatment:
Device: Focused shock wave
Dietary Supplement: Tendisulfur Pro

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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