DEgenerative ROtator Cuff Disease and Botulinum TOXin (DEROTOX)

February 15, 2024 updated by: Assistance Publique - Hôpitaux de Paris

DEgenerative ROtator Cuff Disease and Botulinum TOXin: a Randomized Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Epidemiology:

degenerative rotator cuff disease ranks first in shoulder disorders and is the main cause of chronic shoulder pain in general practice and in rheumatology clinics. It can be responsible for persistent shoulder pain, functional limitation and greatly contributes to occupational disability.

The pathogenesis of rotator cuff disease:

involves tendon impingement and intrinsic tendinopathic abnormality (supra-spinatus, infra-spinatus, teres minor and sub-scapularis muscles). They include apoptosis of the tenocytes that is induced by mechanical constraints and by local hypoxia. The consequences are secondary inflammation and matrix alteration.

Current therapeutic approach:

The first-line recommended treatment for degenerative rotator cuff disease is conservative and includes level 1 and 2 oral analgesics; a short sequence of nonsteroidal anti-inflammatory drugs, if necessary; local injections of corticosteroids; and physiotherapy (low level of evidence). Surgery is a conditional later option.

Study hypothesis:

Reducing mechanical constraints on the supra-spinatus tendon by botulinum toxin may prevent load-induced apoptosis of the tenocytes and tear progression that is associated with clinical expression, and prevent local hypoxia. Furthermore, the muscle inactivity induced by botulinum toxin is not awaited to provide any clinically relevant functional alteration.

Aim of the study:

The primary objective of the study is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease at one-month follow-up, using Shoulder Pain And Disability Index (SPADI) as outcome criterion.

The secondary objective is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease, at three-month follow-up, using SPADI as outcome criterion and safety, the SPADI sub-scores pain and function at 3 months, global improvement perceived at 1 month and 3 months, drug consumption over the 3 months of follow-up, and treatment acceptability at 1 month and 3 months; as well as the tolerance at 1 week.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Paris, France, 75010
        • Recruiting
        • Hopital Lariboisiere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

41 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1- Botulinum toxin

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®).
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.
Placebo Comparator: 2- PLACEBO

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total score of the Shoulder Pain And Disability Index at 1 month. 0 to 100;
Time Frame: 1 month

Total score of the Shoulder Pain And Disability Index :

Scale : 0 to 100, with higher score meaning worst outcome
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: week, 1 month and 3 months

Sub-scores for pain and disability of the Shoulder Pain And Disability Index :

Scale : 0 to 100, with higher score meaning worst outcome
week, 1 month and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Merz Pharmaceuticals GmbH

Investigators

  • Principal Investigator: Johann MD BEAUDREUIL, PHD, Hôpital Lariboisière Fernand Widal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 7, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (Actual)

April 14, 2022

Study Record Updates

Last Update Posted (Actual)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP210416

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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