Tendinopathy Clinical Trial
— AKITENMEDOfficial title:
Evaluation of Collagen-based Medical Device Treatment Combined With Physiotherapy in Subjects With Achilles Tendinopathy. Multicenter Randomized Clinical Investigation; AKITENMED STUDY.
Achilles tendinopathy is a condition characterized by inflammation of the Achilles tendon. Achilles tendinopathies are classified into insertional tendinitis and noninsertional tendinitis. Insertional tendinitis involves the lower part of the tendon, where the tendon inserts at the level of the calcaneus, and can affect even patients who are not particularly athletically active. Noninsertional tendinitis occurs when the fibers in the middle portion of the tendon are affected, affects young and athletic people the most, and has a high incidence (30-50%) in middle-aged individuals. Considering that there are no strong evidence-based guidelines in the area of treatment of achilles tendinopathy, the aim of this research project is to understand through a multicenter, randomized clinical investigation the impact of treatment with a porcine collagen-based medical device administered in the peri-tendon area in combination with physiotherapy on pain reduction and functional improvement of the investigated tendon.
Status | Recruiting |
Enrollment | 72 |
Est. completion date | July 13, 2024 |
Est. primary completion date | February 13, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Male and female subjects aged 18 to 70 years; - Subjects with tendon pain for not more than 24 weeks; - Subjects with clinically diagnosed and ultrasonographically confirmed insertional/noninsertional/mystic tendinopathy; - Subjects with a VISA A score between 50 and 75; - VAS = 5; - Subjects able to understand and answer the SF12 questionnaire; - Subjects able to understand and sign the informed consent. Exclusion Criteria: - subjects who have had surgery in the investigated area or lower extremity; - subjects who have previously undergone physiotherapy. - subjects with autoimmune diseases; - subjects with peripheral neuropathy; - subjects with calcific tendinopathy - subjects with pain of direct traumatic origin; - subjects with local/systemic infections; - subjects with neoplastic diseases; - subjects with gout; - subjects on corticosteroid treatment at the time of enrollment; - subjects who have used corticosteroids or fluoroquinolones in the three months prior to enrollment; - subjects who have used NSAIDs in the week prior to enrollment; - subjects who are pregnant and lactating; - subjects with contraindications to acetaminophen use; - allergy to porcine collagen. |
Country | Name | City | State |
---|---|---|---|
Italy | U.O.C. Medicina Fisica e Riabilitativa dell'AOU "Policlinico Umberto I°" | Roma | RO |
Lead Sponsor | Collaborator |
---|---|
Guna S.p.a |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of the VISA-A questionnaire score at week 8, ranging from 0 to 100 points, where 100 points represents a healthy tendon. | The primary end point will be assessed at week 8 and will involve: Assessment of the VISA-A questionnaire score at time weeks 8 compared to day 0. A difference between the two groups of 12 out of 100 points on the questionnaire can be considered clinically significant.
We measured the VISA-A score (ranging from 0 to 100 points, where 100 points represents a healthy tendon. |
Weeks 8 | |
Secondary | Assessment of the VISA-A (Victorian Institute of Sport Assessment- Achilles) questionnaire score at T3 and T6 weeks, ranging from 0 to 100 points, where 100 points represents a healthy tendon. | Evaluation of VISA-A score at time weeks 3 and weeks 6 compared to day 0. We measured the VISA-A score (ranging from 0 to 100 points, where 100 points represents a healthy tendon | Weeks 3, weeks 6. | |
Secondary | Assessment of the VAS (Visual Analogue Scale) at time weeks 3, weeks 6 and weeks 8, allows the patient to define pain intensity along a line from 0 to 10 cm (100 mm). | Assessment of the VAS (Visual Analogue Scale) at time weeks 3, weeks 6 and weeks 8 compared to day 0.
Visual Analogue Scale (VAS) allows the patient to define pain intensity along a line from 0 to 10 cm (100 mm). One end indicates no pain 'no pain' while the other represents maximum pain 'maximum pain'. |
Weeks 3, weeks 6, weeks 8 | |
Secondary | Evaluation of the SF12 (Item Short Form Survey) questionnaire at times weeks 3, weeks 6 and weeks 8 determinated the phisical condition and mental healthy functioning. | Evaluation of the SF12 (Item Short Form Survey) questionnaire at time weeks 3, weeks 6 and weeks 8 compared to day 0.
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning A score of 50 or less o has been recommended as a cut-off to determine a physical condition; while a score of 42 or less may be indicative of 'clinical depression. The questionnaire needs to be supported by a statistical programme for further analysis. |
Weeks 3, weeks 6 and weeks 8. | |
Secondary | Evaluation of the fraction of subjects in each group achieving Minimal Clinical Disease (MCD) considering that the MCD of the VISA-A questionnaire is 18.5 (90% MCD). | Evaluation of the fraction of subjects in each group achieving Minimal Clinical Disease (MCD) considering that the MCD of the VISA-A questionnaire is 18.5 (90% MCD), after treatment and study duration. | Day 0, week 1, weeks 2,weeks 3, weeks 6 and weeks 8. | |
Secondary | Assessment of analgesic drug unit consumption based on clinical diary | Assessment of analgesic drug unit consumption based on clinical diary at time weeks 3, weeks 6 and weeks 8, (paracetamol 1000 mg. will be used as "rescue dose" in case of onset/recurrence of pain). | Weeks 3,weeks 6 and weeks 8. | |
Secondary | Evaluation of the fraction of subjects in each group who drop out early in relation to Adverse Events (AE/SAE/SUSAR) | Evaluation of the fraction of subjects in each group who drop out early in relation to Adverse Events (AE/SAE/SUSAR | Day 0, week 1,weeks 2,weeks 3,weeks 6 and weeks 8. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05054920 -
Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis
|
N/A | |
Completed |
NCT03307499 -
NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery
|
N/A | |
Completed |
NCT02499484 -
Topical Glyceryl Trinitrate (GTN) and Eccentric Exercises in the Treatment of Midportion Achilles Tendinopathy
|
N/A | |
Completed |
NCT01944150 -
Association of Transcutaneous Electrical Nerve Stimulation and Hypnosis
|
N/A | |
Recruiting |
NCT04578418 -
Effect of Collagen Supplementation on Tendinopathy
|
N/A | |
Completed |
NCT03262181 -
The Acute Effects of an Isometric Loading Intervention on Lower Extremity Landing Biomechanics in Individuals With Patellar Tendinopathy
|
N/A | |
Completed |
NCT03502434 -
A Repeat Insult Patch Test (RIPT) Study Evaluating the Sensitization Potential of Topical SM04755 Solution in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04278833 -
Comparative Effectiveness of Particulate Versus Nonparticulate Steroid Injections for Musculoskeletal Conditions
|
Phase 4 | |
Completed |
NCT05897866 -
Sayed Issa's Hybrid Shoulder Arthroscopic-Open Surgical Management (HSSM)
|
N/A | |
Recruiting |
NCT05603468 -
Effect of PRP vs Corticosteroid in Rotator Cuff Tendinopathy Subtypes in Arthroscopic Repair
|
Phase 4 | |
Terminated |
NCT01544244 -
The Global Shoulder Concept (GSC) Method Versus Classic Physical Therapy for Shoulder Tendinitis
|
N/A | |
Recruiting |
NCT04144946 -
Identification of Early Changes in Patellar Tendinopathy Using Ultra-high Field Strength MRI
|
||
Terminated |
NCT02978833 -
Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy
|
Phase 4 | |
Completed |
NCT03229291 -
A Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of SM04755 Following Topical Administration to Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT06056440 -
Efficacy of a Physical Rehabilitation Program Using Virtual Reality in Patients With Chronic Tendinopathy (Virtendon-Rehab)
|
N/A | |
Recruiting |
NCT04058509 -
Clinical Predictors of Extracorporal Shockwave Therapy Efficacy in Patients Presenting With Lateral Hip Pain
|
N/A | |
Withdrawn |
NCT02981394 -
Clinical Outcomes of Autologous Bone Marrow Aspirate Concentrate Injections for Musculoskeletal Conditions
|
||
Active, not recruiting |
NCT02600910 -
Natural History of Shoulder Pathology in Manual Wheelchair Users
|
||
Completed |
NCT04793971 -
Minimal Invasive Treatment of Achilles Tendinopathy: Focus on Percutaneous Release (Maffulli)
|
||
Not yet recruiting |
NCT01225497 -
Eccentric Exercise for Chronic Mid-portion Achilles Tendinopathy
|
N/A |