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Study on Botulinum Toxin for Patients with Degenerative Rotator Cuff Tendinopathy

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for degenerative rotator cuff disease, a condition affecting the shoulder. The treatment being tested is called Xeomin, which contains a substance known as botulinum toxin. This toxin is used in various medical treatments to help reduce muscle activity and pain.

The purpose of the study is to evaluate how effective botulinum toxin is in treating shoulder pain and disability caused by degenerative rotator cuff disease. Participants in the study will receive either the Xeomin treatment or a placebo, which is a substance with no active medication. The study will monitor changes in shoulder pain and function over a period of one month, using a tool called the Shoulder Pain and Disability Index (SPADI) to measure outcomes.

Throughout the study, participants will be asked to attend regular visits to assess their progress. The study will also track any changes in pain levels and the use of pain medication over a three-month period. The goal is to determine if the treatment can provide relief from shoulder pain and improve daily function for those with degenerative rotator cuff disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, pain duration, and intensity, as well as ensuring that any pain medications have remained unchanged for at least 30 days prior to enrollment.

    An ultrasound is performed to check for supraspinatus tendinopathy, with or without rupture. A negative urine test is required for women of childbearing age.

  2. Step 2

    Treatment administration

    The treatment involves an intramuscular injection of either Xeomin (botulinum toxin type A) or a placebo. The injection is administered as a solution for injection.

  3. Step 3

    Follow-up at one month

    One month after the injection, the effectiveness of the treatment is evaluated using the Shoulder Pain and Disability Index (SPADI) score. This assessment measures pain and disability levels.

  4. Step 4

    Follow-up at three months

    Three months after the injection, a secondary evaluation is conducted. This includes the total SPADI score, SPADI sub-scores, perceived overall improvement, and painkiller medication consumption.

    The acceptability of the treatment is also assessed using a visual analog scale (VAS) from 0 to 100.

Who can join the trial?

12 criteria

  • Must be older than 40 years.
  • Must be available for all planned visits during the study.
  • Women who can have children must use an effective birth control method starting at least 1 month before and continuing for at least 1 month after receiving the study treatment.
  • Women who can have children must have a negative urine pregnancy test.
  • Must have had pain for more than 1 month.
  • Pain must be rated at least 40 out of 100 on a scale where 0 means no pain and 100 means the worst pain imaginable.
  • Must have a score of at least 30 out of 100 on the **Shoulder Pain And Disability Index (SPADI)**, which measures shoulder pain and how it affects daily activities.
  • Must not have changed pain medications in the 30 days before joining the study.
  • Must experience pain, with or without weakness, during the **Jobe maneuver**, a test used to check shoulder strength.
  • Must have had an **ultrasound** within 30 days showing **supraspinatus tendinopathy**, which is a condition affecting a shoulder tendon, with or without a tear.
  • Must be part of a social security scheme.
  • Must be able to give consent and complete a weekly notebook to record any pain medications taken.

Who cannot join the trial?

9 criteria

  • Patients who have had a recent shoulder injury or surgery.
  • Individuals with a known allergy to **botulinum toxin**, which is a substance used to relax muscles.
  • People with certain neurological disorders, which are conditions affecting the brain, spinal cord, or nerves.
  • Participants who are currently pregnant or breastfeeding.
  • Individuals with an active infection in the shoulder area.
  • Patients who are taking medications that might interfere with the study treatment.
  • Anyone who has participated in another clinical trial within the last 30 days.
  • People with a history of drug or alcohol abuse.
  • Individuals with severe medical conditions that might affect their ability to participate in the study.
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Investigated drugs

Botulinum Toxin is being studied for its effectiveness in treating degenerative tendinopathy of the rotator cuff in the shoulder. This medication is commonly used to reduce muscle stiffness and spasms by temporarily blocking nerve activity in the muscles. In this trial, it is being evaluated to see if it can help reduce shoulder pain and improve function as measured by the Shoulder Pain and Disability Index score.

What is already known about the treatment

Botulinum Toxin – This medication is administered through injection directly into the affected area. It is currently being studied for its effectiveness in treating degenerative tendinopathy of the shoulder's rotator cuff. The main therapeutic indication is to reduce pain and improve function in patients with this condition. At the molecular level, botulinum toxin works by blocking the release of a neurotransmitter called acetylcholine, which reduces muscle contractions and alleviates pain. It is classified as a neurotoxin and is commonly used in various medical and cosmetic applications.

Investigated diseases

Degenerative Shoulder Rotator Cuff Tendinopathy – This condition involves the gradual wear and tear of the tendons in the rotator cuff of the shoulder. It typically results from repetitive stress or aging, leading to tendon degeneration. As the tendons weaken, individuals may experience shoulder pain and reduced range of motion. Over time, the condition can cause difficulty in performing daily activities that involve shoulder movement. The progression of the disease can vary, with some people experiencing mild discomfort while others may have significant pain and functional limitations.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514074-40-00Protocol codeAPHP210416Estimated enrolment60 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).