Do ultrasound guided botulinum A injections relieve pain in rotator cuff arthropathy?

Phase 1

• Conditions: Rotator Cuff Tear Arthropathy; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2015-002176-25-GB
• Lead Sponsor: Royal Devon and Exeter NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-16
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Inclusion criteria
The only eligibility criterion for participation in this study is that the patient is medically fit for an operation and diagnosed with symptomatic rotator cuff arthropathy. They must be able to give informed consent and have evidence of cuff arthropathy on plain radiographs of the affected shoulder. They have to be over the age of 60 years, with no upper age limit.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

Exclusion criteria
Contra-indications to surgery (defined as severe cardiac impairment, e.g. heart or valve replacement, arrhythmia, previous myocardial infarction; severe respiratory impairment, e.g. chronic obstructive pulmonary disease, asthma that has required hospital admission; any other systemic medical condition that would produce a specific contraindication to a general anaesthetic).
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.

Other exclusion criteria include:
Previous fractures or dislocations of the shoulder.
Previous surgery on the affected shoulder.
Any neurological or medical condition resulting in spasticity
Having botox for any other reason in the past three months
Under age 60.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine if the use of guided botulium A toxin injections reduces pain in patients suffering from cuff tear arthopathy.;Secondary Objective: Does a patient's oxford shoulder score improve with the use of a botulinum A toxin injection? This is a validated score made up of twelve activities of daily living that allows surgeons to provide an objective measure of how badly a person's shoulder problem affects them on a day to day basis. <br>Does a patients EQ5D score improve following Botox A injections.;Primary end point(s): The primary outcome measure will be the subjects VAS pain scores at pre-intervention, 6 weeks, 3 months and 6 months;Timepoint(s) of evaluation of this end point: 6 months following the final participants Botulinum type A Toxin injection.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Oxford shoulder scores and EQ5D scores at 6 months following injection ;Timepoint(s) of evaluation of this end point: 6 months following the final participants botulinum toxin Type A injection.