Ongoing Clinical Trials for Tendon Disorder
There are currently 4 ongoing clinical trials investigating new treatments for tendon disorders. These studies are testing different medications to help reduce pain and improve tendon function. Trials are taking place across several European countries, focusing on common tendon problems affecting the shoulder and ankle. The treatments being studied include botulinum toxin, regenerative microparticles, and medications that target inflammation in the tendons.
Clinical trial locations
- Bulgaria
- Czechia
- Denmark
- Espagne
- France
- Germany
- Greece
- Hungary
- Italy
- Netherlands
- Poland
- Portugal
- Slovakia
- Spain
Study on Botulinum Toxin for Patients with Degenerative Rotator Cuff Tendinopathy
This trial is investigating whether botulinum toxin can help reduce shoulder pain and improve function in people with degenerative rotator cuff disease. The condition affects the tendons in the shoulder, causing gradual wear and tear that leads to pain and difficulty moving the arm.
Who can participate:
To join this study, you must be over 40 years old and have experienced shoulder pain for more than one month. Your pain should be rated at least 40 out of 100 on a pain scale, and your shoulder problems should score at least 30 out of 100 on the Shoulder Pain and Disability Index. An ultrasound must show evidence of supraspinatus tendinopathy, with or without a tear. You must not have changed your pain medications in the 30 days before joining. Women who can become pregnant must use effective birth control and have a negative pregnancy test.
Who cannot participate:
You cannot join if you have had a recent shoulder injury or surgery, if you are allergic to botulinum toxin, or if you have certain neurological disorders. Pregnant or breastfeeding women are excluded, as are people with active shoulder infections or those taking medications that might interfere with the treatment. You also cannot participate if you have been in another clinical trial in the past 30 days or have a history of drug or alcohol abuse.
What the study involves:
Participants receive a single injection of either Xeomin, which contains botulinum toxin, or a placebo into the shoulder muscle. The study monitors changes in shoulder pain and function over one month using the Shoulder Pain and Disability Index. Follow-up continues for three months to assess pain levels, overall improvement, and use of pain medication. Botulinum toxin works by temporarily blocking nerve signals to muscles, which may help reduce pain and muscle stiffness.
Study on the Safety and Effects of NGI226 Microparticles for Patients with Achilles Tendinopathy
This study is evaluating NGI226, a new treatment designed to help heal the Achilles tendon in people with Achilles tendinopathy. This condition causes pain and swelling in the tendon at the back of the ankle, making it difficult to walk or exercise.
Who can participate:
You can join if you are between 30 and 70 years old and have Achilles tendinopathy confirmed by a doctor through physical examination and imaging tests such as ultrasound or MRI. Your symptoms must have been present for at least 8 weeks but less than 12 months. You must have tried at least 6 weeks of conservative treatment, including physiotherapy, anti-inflammatory drugs, and the RICE method (Rest, Ice, Compression, Elevation), without success.
Who cannot participate:
You cannot participate if you have had Achilles tendon surgery in the past 6 months, have a history of allergic reactions to similar treatments, or are currently in another clinical trial. People with severe medical conditions, pregnant or breastfeeding women, and those with infections or skin conditions at the injection site are excluded. You also cannot join if you have received other treatments for Achilles tendinopathy in the last 3 months or have blood clotting disorders.
What the study involves:
After confirming eligibility and conducting baseline assessments, participants receive a single injection of either NGI226 microparticles or a placebo near the affected tendon. The microparticles are a powder mixed into a liquid and injected directly around the tendon. Regular follow-up visits monitor for side effects and changes in symptoms such as pain and swelling. The study uses ultrasound-based shear wave elastography to measure tendon stiffness before and after treatment, helping determine if NGI226 promotes tendon healing and regeneration.
Study on the Effectiveness and Safety of Secukinumab for Adults with Moderate to Severe Rotator Cuff Tendinopathy
This trial is testing whether secukinumab, a medication that reduces inflammation, can improve shoulder symptoms better than a placebo in people with moderate to severe rotator cuff tendinopathy. The condition causes shoulder pain and difficulty with movement due to inflammation or irritation of the tendons.
Who can participate:
You must have moderate to severe rotator cuff tendinopathy in one shoulder, with symptoms lasting between 6 weeks and 6 months. You need to experience nighttime shoulder pain on at least 3 out of 7 nights or have a positive painful arc test. Your Total WORC percentage score must be 40 or less, and your average weekly pain score must be 5 or more on a 0-10 scale. You must have tried NSAIDs and physiotherapy for 8 weeks without improvement and agree to maintain the same dose throughout the study. An MRI must confirm tendinopathy with no tear or only a small partial tear.
Who cannot participate:
You cannot join if you have other shoulder conditions unrelated to rotator cuff tendinopathy or if you have had shoulder surgery in the past 6 months. People currently using immune system medications, those with severe allergic reactions to medications, or those with active infections or frequent infection history are excluded. You also cannot participate if you have had cancer in the past 5 years (except certain skin cancers), have severe heart, liver, or kidney problems, are pregnant or breastfeeding, or are in another clinical trial.
What the study involves:
Participants receive either secukinumab (300 mg) or a placebo as an injection under the skin at specified intervals over 24 weeks. Neither participants nor study staff know who receives which treatment. The study measures changes in shoulder symptoms using the Western Ontario Rotator Cuff Index at weeks 16 and 24. Regular check-ups monitor safety and side effects, including blood tests. Secukinumab works by blocking interleukin-17A, a protein involved in inflammation, which may help reduce pain and improve shoulder function.
Study on the Effectiveness and Safety of Secukinumab for Adults with Moderate to Severe Rotator Cuff Tendinopathy
This is another study examining secukinumab for rotator cuff tendinopathy, with a similar design but conducted in different European countries. Like the previous trial, it aims to determine if secukinumab can reduce inflammation and improve shoulder symptoms better than a placebo.
Who can participate:
Eligibility requirements are the same as the previous secukinumab study. You must be 18 to 65 years old with moderate to severe rotator cuff tendinopathy lasting between 6 weeks and 6 months. You need nighttime shoulder pain on at least 3 out of 7 nights or a positive painful arc test, a WORC score of 40 or less, and an average pain score of 5 or more. You must have tried NSAIDs and physiotherapy for 8 weeks without success and maintain these treatments throughout the study. An MRI must show tendinopathy with no significant tears.
Who cannot participate:
Exclusion criteria match the previous secukinumab trial. You cannot participate if you have other shoulder conditions, recent shoulder surgery, are using immune system medications, have severe allergies, active infections, cancer history (past 5 years), severe organ problems, are pregnant or breastfeeding, or are in another trial.
What the study involves:
The study follows the same protocol as the other secukinumab trial. After initial assessments and MRI confirmation, participants are randomly assigned to receive either secukinumab (300 mg injected under the skin) or placebo. The study lasts 24 weeks with follow-up visits at weeks 4, 16, and 24. Researchers evaluate shoulder symptoms using standardized questionnaires and pain scales, while monitoring safety through blood tests and checking for any side effects or anti-drug antibodies.
Summary
Four clinical trials are currently investigating treatments for tendon disorders across multiple European countries. Three of the four trials focus on rotator cuff tendinopathy affecting the shoulder, while one addresses Achilles tendinopathy in the ankle. The concentration of trials in France, Denmark, and several other European nations reflects regional research initiatives in tendon disorders.
The studies test different therapeutic approaches: botulinum toxin for muscle relaxation and pain reduction, NGI226 microparticles for tendon regeneration, and secukinumab for inflammation control. Notably, two separate trials are evaluating secukinumab in different European locations, suggesting significant interest in this anti-inflammatory approach. All trials require participants to have tried conventional treatments like physiotherapy and anti-inflammatory medications without adequate relief before joining.
Most studies use placebo comparisons and blinded designs to ensure reliable results. The trials vary in duration from one month to six months of follow-up, allowing researchers to assess both short-term and longer-term effects of these treatments on pain, function, and tendon healing.
