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

Study Overview
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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).

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

Conditions
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Fasciitis, Plantar

Intervention / Treatment
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* Dietary Supplement: Tendisulfur Pro
* Device: Focused shock wave


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: shock wave<br> | Device: Focused shock wave<br>* 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.<br>|
| Active Comparator: shock wave and tendon supplement<br> | Dietary Supplement: Tendisulfur Pro<br>* 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)<br>Device: Focused shock wave<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in American Foot & Ankle Score (AOFAS) | The scores ranging between 100 (no disability) and 0 (maximum disability) | T0 (recruitment); T2 (six months) | 
| Change in Foot Function Index (FFI) | The scores ranging between 100 (no disability) and 0 (maximum disability). | T0 (recruitment); T2 (six months) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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focused shock waves, tendinitis, natriuretics