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

Fasciitis, Plantar Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04664712
• Other study ID #: ESWT-TP
• Status: Completed
• Phase: N/A
• Start date: September 11, 2019
• Est. completion date: November 20, 2020

Study information

• Verified date: November 2020
• Source: Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: November 20, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar

Intervention

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.

Locations

Country	Name	City	State
Italy	AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia	Bari

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	T0 (recruitment); T1 (three months)
Primary	Change in Visual Analogue Score (VAS)	The pain was quantified using the VAS scale with the scores ranging between 0 (no pain)	T1 (three months); T2 (six months)
Secondary	Change in American Foot & Ankle Score (AOFAS)	The scores ranging between 100 (no disability) and 0 (maximum disability)	T0 (recruitment); T2 (six months)
Secondary	Change in Foot Function Index (FFI)	The scores ranging between 100 (no disability) and 0 (maximum disability).	T0 (recruitment); T2 (six months)
Secondary	Roles & Maudsley (R&M)	Monitorization of the patient's perception of improvement, with the scores ranging from 1 (excellent) to 4 (minimum).	T1 (three months)
Secondary	Roles & Maudsley (R&M)	Monitorization of the patient's perception of improvement, with the scores ranging from 1 (excellent) to 4 (minimum).	T2 (six months)