NCT04664712

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Fasciitis, Plantar

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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)
DEVICE	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.

Timeline

• Start date: 2019-09-11
• Primary completion: 2020-05-01
• Completion: 2020-11-20
• First posted: 2020-12-11
• Last updated: 2020-12-11

Locations

1 site across 1 country: Italy