Subacromial Injections for Shoulder Subacromial Pain Syndrome - Anterolateral vs Posterior Approach
1 other identifier
interventional
86
1 country
1
Brief Summary
This study aims to determine if there is any difference in terms of pain relief in patients with shoulder subacromial pain syndrome, when given a steroid injection into the subacromial space via an anterolateral approach compared to a posterior approach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedFirst Posted
Study publicly available on registry
November 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedNovember 25, 2019
November 1, 2019
3 years
October 30, 2019
November 21, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Oxford Shoulder Score
The primary outcome measure will be the change in the Oxford Shoulder Score at 3 months post injection. Scores range from 0-48 with 48 being the best possible outcome.
3 months
Secondary Outcomes (4)
Oxford Shoulder Score
6 months and 1 year
Pain on visual analogue scale
3 months, 6 months and 1 year post injection
Disabilities of Arm, Shoulder and Hand Questionnaire
3 months, 6 months and 1 year
Short Form 36 Health Survey Score
3 months, 6 months and 1 year
Study Arms (2)
Anterolateral Approach
ACTIVE COMPARATORThe randomised group of patients receiving the subacromial steroid injection via an anterolateral approach
Posterior Approach
ACTIVE COMPARATORThe randomised group of patients receiving the subacromial steroid injection via a posterior approach
Interventions
Applying to the anterolateral approach arm, this group will receive their subacromial steroid injection via an anterolateral approach
Applying to the posterior approach arm, this group will receive their subacromial steroid injection via an posterior approach
Eligibility Criteria
You may qualify if:
- Patient diagnosed with shoulder subacromial pain syndrome
- Age ≥ 18
- Capacity to give valid consent for participation
- Able to complete the follow up
You may not qualify if:
- Age \< 18
- Lacking capacity/unable to give valid consent for participation
- Full thickness rotator cuff tear diagnosed on either Ultrasound scan or Magnestic Resonance Imaging
- Unable to complete follow up
- Unable to speak or read English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, FY3 8NR, United Kingdom
Study Officials
- PRINCIPAL INVESTIGATOR
Charalambos Charalambous
Consultant Orthopaedic Surgeon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Orthopaedic Surgeon
Study Record Dates
First Submitted
October 30, 2019
First Posted
November 20, 2019
Study Start
November 1, 2019
Primary Completion
November 1, 2022
Study Completion
April 1, 2023
Last Updated
November 25, 2019
Record last verified: 2019-11