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RecruitingPhase 2NCT05327972

DEgenerative ROtator Cuff Disease and Botulinum TOXin

DEgenerative ROtator Cuff Disease and Botulinum TOXin: a Randomized Trial

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

60 participants

Start Date

Jan 20, 2023

Study Type

INTERVENTIONAL

Conditions

Degenerative Rotator Cuff Disease

Summary

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

Eligibility

Min Age: 41 Years

Inclusion Criteria12

  • 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 Criteria21

  • 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)

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Interventions

DRUGThe investigational medicinal product is incobotulinumtoxinA (XEOMIN®).

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.

OTHERPLACEBO

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

Locations(1)

Hôpital LARIBOISIERE

Paris, Paris, France

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NCT05327972