Does Botulinum A Toxin Help With Pain From Rotator Cuff Arthropathy?

NCT02512536 | Completed Phase 2 DMC

• 1 other identifier: 1510150
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Rotator cuff arthropathy is a cause of shoulder arthritis which is a common condition seen both in primary and secondary care. It is a painful condition, with significant disability. Specialist shoulder replacements have found acceptance within the trust, nationally and internationally although there are high complication rates. There is however a significant cost difference (fifty fold) between a reverse total shoulder replacement and a botox injection, and to date there have been no randomised control trials, or any registered, comparing the use of a botox injection for pain relief in cuff arthropathy versus no treatment. If there is a significant clinical difference in the pain outcomes between the two, this could result in significant savings to the NHS and the taxpayer as a whole. If high levels of pain relief could be predictably obtained using Botulinum A toxin injections then potentially patients could avoid the need for surgery.

Conditions

Rotator Cuff Tear Arthropathy

Outcome Measures

Primary Outcomes (1)

• Post injection Oxford Shoulder Scores

  PROM

  At 6 weeks, 3 months and 6 months after injection.

Secondary Outcomes (1)

• Pain score

  At 6 weeks, 3 months and 6 months after injection.

Study Arms (1)

Experimental

EXPERIMENTAL

Intervention: Subjects receiving a single ultrasound scan guided injection of Botulinum Toxin type A into the supraspinatus muscle belly. Drug: Dysport 300 units im. One single injection over course of study.

Drug: Botulinum Toxin Type A

Interventions

Botulinum Toxin Type A DRUG

Ultrasound scan guided injection into supraspinatus muscle belly with Botulinum Toxin Type A

Also known as: Dysport

Experimental

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Evidence that the patient would be unable to adhere to trial procedures or complete questionnaires, such as dementia or intravenous drug abuse Note: If a recruited patient requires a contra-lateral shoulder botox injection during the trial period, this second shoulder cannot be included in the study since the result of this intervention would not be independent from the first intervention.
• Previous fractures or dislocations of the shoulder. Previous surgery on the affected shoulder. Any neurological or medical condition resulting in spasticity

Sponsors & Collaborators

• Royal Devon and Exeter NHS Foundation Trust: lead

Study Sites (1)

Royal Devon and Exeter hospital

Exeter, Devon, United Kingdom

Location

MeSH Terms

Conditions

Rotator Cuff Tear Arthropathy

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

Chondrocalcinosis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Chris Smith

  Royal Devon and Exeter NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2015
• First Posted: July 31, 2015
• Study Start: July 1, 2016
• Primary Completion: November 22, 2017
• Study Completion: November 22, 2017
• Last Updated: February 25, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)