DEgenerative ROtator Cuff Disease and Botulinum TOXin

NCT05327972 | Recruiting Phase 2

• 1 other identifier: APHP210416
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease.

Conditions

Degenerative Rotator Cuff Disease

Keywords

Degenerative rotator cuff disease; Botulinum toxin; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Total score of the Shoulder Pain And Disability Index at 1 month. 0 to 100;

  Total score of the Shoulder Pain And Disability Index : Scale : 0 to 100, with higher score meaning worst outcome

  1 month

Secondary Outcomes (1)

• Sub-scores for pain and disability of the Shoulder Pain And Disability Index at 1 month and 3 months Total score of the Shoulder Pain And Disability Index at 3 months Safety at 1 week, 1 month and 3 months

  week, 1 month and 3 months

Study Arms (2)

1- Botulinum toxin

EXPERIMENTAL

The investigational medicinal product is incobotulinumtoxinA (XEOMIN®). The dosage is: Two milliliters of a mixture comprised of XEOMIN® 100 U and saline solution 0.9% will be once injected in the supra-spinatus muscle using ultrasonography guidance.

Drug: The investigational medicinal product is incobotulinumtoxinA (XEOMIN®).

2- PLACEBO

PLACEBO COMPARATOR

The placebo comparator represents a saline solution containing an inactive lyophilisate. The dosage is: Two milliliters of a saline solution containing an inactive lyophilisate will be once injected in the supra-spinatus muscle using ultrasonography guidance.

Other: PLACEBO

Interventions

The investigational medicinal product is incobotulinumtoxinA (XEOMIN®). DRUG

Two milliliters of a mixture comprised of XEOMIN® 100 U and saline solution 0.9% will be once injected in the supra-spinatus muscle using ultrasonography guidance.

1- Botulinum toxin

PLACEBO OTHER

Two milliliters of a saline solution containing an inactive lyophilisate will be once injected in the supra-spinatus muscle using ultrasonography guidance.

2- PLACEBO

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Merz Pharmaceuticals GmbH: collaborator

Study Sites (1)

Hôpital LARIBOISIERE

Paris, Paris, 75010, France

RECRUITING

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Related Links

• Haute Autorité de Santé. Clinical practice guidelines. Management of chronic painful shoulder without instability in adults. April 2005
• Rouvière H, Delmas A. Anatomie humaine, descriptive, topographique et fonctionnelle, tome 3 : membres, système nerveux central. 13ème édition. Paris : Masson ; 1991

MeSH Terms

Interventions

incobotulinumtoxinA

Study Officials

• Johann MD BEAUDREUIL, PHD

  Hôpital Lariboisière Fernand Widal

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johann MD BEAUDREUIL, PHD

CONTACT

+33(0) 1 49 95 63 08; johann.beaudreuil@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: January 20, 2023
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)