Efficacy of Focused Shock Waves Combined With Adjuvant Therapy With Tendon Supplement
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: shock wave
|
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.
|
| Active Comparator: shock wave and tendon supplement
|
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.
|
Outcome Measures
Primary Outcome Measures
- Change in Visual Analogue Score (VAS) [T0 (recruitment); T1 (three months)]
The pain was quantified using the VAS scale with the scores ranging between 0 (no pain) and 10 (worst imaginable pain).
- Change in Visual Analogue Score (VAS) [T1 (three months); T2 (six months)]
The pain was quantified using the VAS scale with the scores ranging between 0 (no pain)
Secondary Outcome Measures
- Change in American Foot & Ankle Score (AOFAS) [T0 (recruitment); T2 (six months)]
The scores ranging between 100 (no disability) and 0 (maximum disability)
- Change in Foot Function Index (FFI) [T0 (recruitment); T2 (six months)]
The scores ranging between 100 (no disability) and 0 (maximum disability).
- Roles & Maudsley (R&M) [T1 (three months)]
Monitorization of the patient's perception of improvement, with the scores ranging from 1 (excellent) to 4 (minimum).
- Roles & Maudsley (R&M) [T2 (six months)]
Monitorization of the patient's perception of improvement, with the scores ranging from 1 (excellent) to 4 (minimum).
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia | Bari | Italy | 70124 |
Sponsors and Collaborators
- Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Investigators
- Principal Investigator: Biagio Moretti, Prof, University of Bari Aldo Moro
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ESWT-TP