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Clinical Trials/EUCTR2012-000147-27-GB
EUCTR2012-000147-27-GB
Active, not recruiting
Not Applicable

A Single-Blind Randomised Controlled Pilot trial of Corticosteroid Injection for Shoulder Pain - Pilot Trial of Steroid Injection for Shoulder Pain (RCT2), Version 1

niversity of Oxford0 sitesJuly 12, 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rotator cuff tendinopathyAdhesive capsulitis of the shoulder joint
Sponsor
niversity of Oxford
Status
Active, not recruiting
Last Updated
12 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 12, 2012
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Male or female, aged 35 to 74 years
  • Diagnosed with rotator cuff tendinopathy or adhesive capsulitis by a general practitioner trained in shoulder assessment, with duration of symptoms no greater than 6 months
  • Willing to allow his or her usual General Practitioner to be notified of participation in the study and to be contacted for further information if an adverse event related to the trial occurs
  • Able to complete follow\-up data collection by questionnaire at 2, 4 and 12 weeks
  • Willing and able to give informed consent for participation in the trial
  • Are the trial subjects under 18? no
  • Number of subjects for this age range: 0
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range 35
  • F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • Female participants who are pregnant, lactating or planning pregnancy during the course of the study
  • Participants who have participated in another research study involving an investigational product in the past 12 weeks
  • Those having already received a shoulder injection in the past 12 months
  • Those with other established chronic shoulder disorders (e.g. rheumatoid arthritis, other inflammatory poly\-arthropathies and osteroarthritis)
  • A history of previous shoulder surgery on the affected side
  • Those with evidence of active infection anywhere, including temperature \= to or \> than 37\.5oC
  • Those currently prescribed anticoagulants
  • Those either currently prescribed or likely to need during the following 12 months, systemic corticosteroids for any reason
  • Immunocompromised
  • Uncontrolled diabetes or uncontrolled hypertension

Outcomes

Primary Outcomes

Not specified

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