Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04965376 |
| Other study ID # |
Pending |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
August 1, 2021 |
| Est. completion date |
August 2025 |
Study information
| Verified date |
September 2023 |
| Source |
Blackpool Teaching Hospitals NHS Foundation Trust |
| Contact |
Charalambos P Charalambous |
| Phone |
01253 300000 |
| Email |
mr.charalambous[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The aim of this study is to determine if there is any difference in terms of pain relief in
patients with frozen shoulder, when given a steroid injection as a suprascapular nerve block
compared to a glenohumeral joint intra-articular injection.
The investigators hypothesis is that there is a significant difference in terms of pain
relief at 3 months, 6 months and 1 year between a steroid injection as a suprascapular nerve
block compared to a glenohumeral joint intra-articular injection.
Participants who attend the orthopaedic clinic and are diagnosed with unilateral frozen
shoulder and who are suitable to be treated with a steroid injection will be identified. If
the participant consents to having a steroid injection, he/she will then be invited to
participate in the trial where they will have an injection either into the glenohumeral joint
(ball and socket joint of the shoulder) or as a suprascapular nerve block (injection adjacent
to a nerve over the shoulder blade) under ultrasound guidance. Participants will then be
followed up at 3, 6 and 12 months after their injection and asked to complete a set of
questionnaires assessing pain, function and movement. The results of the groups will then be
compared to see if one treatment is superior to the other.
Description:
This is a single centre, parallel, two-arm, randomized clinical trial. The trial is expected
to take a total of 3 years with 12-18 months for patient recruitment, 12 months for follow up
and 6-12 months for data collection, analysis and publication.
The null hypothesis is that there will be no differences in terms of pain relief at 3 months,
6 months and 1 year between a steroid injection as a suprascapular nerve block compared to a
glenohumeral joint intra-articular injection.
Adult patients diagnosed with unilateral frozen shoulder who are suitable to be treated with
a steroid injection will receive a verbal explanation of the study by a suitably qualified
member of the research team alongside an information leaflet. Eligible, consented
participants will be randomised in a 1:1 ratio by the selection of sealed, opaque envelopes
with one of the two injection types documented inside. Participants will be free to withdraw
from the study at any time without prejudice. The injection types include an ultrasound
guided steroid injection into the glenohumeral joint (10mls of 1% lidocaine with 40mg
depo-medrone) or an ultrasound guided steroid injection as a suprascapular nerve block at the
spinoglenoid notch adjacent to the nerve as it traverses under the spinoglenoid ligament
(10mls of 1% lidocaine with 40mg depo-medrone. Following both injections, participants are
taken through a protocol of physiotherapy for their frozen shoulder over the subsequent 3
months. Participants will be seen back in the outpatient clinic 3 months after their
injection to review their progress and collect follow-up data. Further follow-up data will be
collected by the completion of questionnaires via post at 6 months and 12 months after the
injection. The primary outcome measure of this study is the Oxford Shoulder Score (OSS) at 3
months post-injection. Secondary end points include Oxford Shoulder Score at 6 months and 1
year, pain using the Pain Numeric Rating Scale at 3 months, 6 months and 1 year, Quick
Disabilities of Arm, Shoulder and Hand (QuickDASH) questionnaire at 3 months, 6 months and 1
year and EQ-5D-5L at 3 months, 6 months and 1 year.
Baseline demographic and clinical variables will be reported using summary statistics. In
terms of the primary outcome, the change in total Oxford Shoulder Score from baseline to 3
months post-injection will be compared between the two groups using either the Independent
Samples t-Test or Mann-Whitney U Test, with the final choice depending on an exploration of
the data. The same approach will be adopted for secondary outcomes. All analysis will be
performed according to the intention to treat principle.
