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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| shock wave | Active Comparator |
| |
| shock wave and tendon supplement | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Biagio Moretti, Prof | University of Bari Aldo Moro | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia | Bari | 70124 | Italy |
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| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| D052256 | Tendinopathy |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
| D009135 | Muscular Diseases |
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|
| 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. |
|
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) |
| D013708 |
| Tendon Injuries |
| D014947 | Wounds and Injuries |