Botulinum toxin for treating shoulder pain from degenerative rotator cuff disease

DEgenerative ROtator Cuff Disease and Botulinum TOXin: a Randomized Trial

This study is testing if botulinum toxin can help relieve shoulder pain in people over 40 with degenerative rotator cuff disease.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 41 Years and up
• Sex: All
• Sponsor: Assistance Publique - Hôpitaux de Paris (other)
• Locations: 1 site (Paris, Paris)
• Trial ID: NCT05327972 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of botulinum toxin (incobotulinumtoxinA) in alleviating persistent shoulder pain caused by degenerative rotator cuff disease. The research focuses on patients over 40 years old who have experienced significant pain for more than a month and have ultrasound-confirmed tendinopathy. Participants will receive either the botulinum toxin or a placebo, and their pain levels and functional outcomes will be monitored throughout the study. The hypothesis is that botulinum toxin may reduce mechanical stress on the affected tendon, potentially preventing further damage and pain.

Who should consider this trial

Good fit: Ideal candidates are individuals over 40 years old with chronic shoulder pain lasting more than one month and confirmed tendinopathy of the supra-spinatus.

Not a fit: Patients with reduced passive range of motion, instability, or other specific shoulder conditions may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could provide significant pain relief and improved function for patients suffering from chronic shoulder pain due to degenerative rotator cuff disease.

How similar studies have performed: While the use of botulinum toxin for shoulder pain is an emerging area, similar studies have shown promising results, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* age \> 40 years;
* pain duration \> 1 month;
* pain intensity ≥ 40/100 on visual analog scale;
* SPADI ≥ 30/100;
* medication against pain stable at least 30 days before enrolment;
* pain with or without weakness during the Jobe manoeuver;
* ultrasonography within the 30 days, showing tendinopathy of the supra-spinatus, with or without tear;
* affiliation to health insurance Sécurité Sociale;
* ability to give consent, complete the weekly notebook (collection of drug treatments taken against pain);
* availability for the visits planned by the protocol;
* use of an effective method of contraception in women of childbearing potential, started at least 1 month before and lasting for at least 1 month after receiving study treatment.
* Negative urine test for women of childbearing age

Exclusion Criteria:

* reduced passive range of motion;
* antero-posterior instability;
* tendinous calcification;
* ultrasonography showing concomitant tear of the infra-spinatus or the subscapularis;
* corticosteroid injection within the previous 30 days;
* previous surgery of the shoulder;
* humeral fracture, inflammatory joint disease and neoplastic disorders;
* contraindication to XEOMIN® (allergy to XEOMIN® or any other botulinum toxin product);
* skin infection at the planned injection site;
* participation in another interventional research involving the human person (RIPH) during the 3 months of follow-up of the DEROTOX Research; participation in another RIPH will be possible beyond these 3 months;
* concomitant use of aminoglycosides, cyclosporine, aminoquinolines and spectinomycine;
* patients with a history of aspiration pneumonia and dysphagia;
* patients on anticoagulant therapy or on therapy that may have an anticoagulant effect;
* Patients with bleeding disorders;
* Patients with amyotrophic lateral sclerosis, myasthenia gravis or, Lambert-Eaton syndrome;
* Patients with other conditions causing peripheral neuromuscular dysfunction;
* In target muscles that show pronounced weakness or atrophy;
* Women of childbearing age who have not performed a urine pregnancy test and or who have a positive urine pregnancy test;
* in case of pregnancy, breastfeeding
* injection of botulinum toxin in the last 6 months
* vulnerable people (under legal protection, guardianship or curatorship)

Where this trial is running

Paris, Paris

• Hôpital LARIBOISIERE — Paris, Paris, France (RECRUITING)

Study contacts

• Principal investigator: Johann MD BEAUDREUIL, PHD — Hôpital Lariboisière Fernand Widal
• Study coordinator: Johann MD BEAUDREUIL, PHD

Conditions: Degenerative Rotator Cuff Disease, Degenerative rotator cuff disease, Botulinum toxin, Clinical trial