Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04170166 |
| Other study ID # |
249246 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 2019 |
| Est. completion date |
April 2023 |
Study information
| Verified date |
November 2019 |
| Source |
Blackpool Teaching Hospitals NHS Foundation Trust |
| Contact |
Maureen Morgan |
| Phone |
+441253955453 |
| Email |
maureen.morgan1[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Patients who present with subacromial pain syndrome (disorders such as subacromial bursitis,
rotator cuff tendinopathy, calcific tendinitis, subacromial inflammation with a partial
thickness rotator cuff tear) to the orthopaedic outpatient clinic are treated initially with
a subacromial steroid injection in addition to physiotherapy for a period of 3 months. This
applies to patients who have had no other treatments previously as well as to patients who
have had previous physiotherapy or steroid injections prior to presentation. Patients who do
not want to undergo the treatment offered are either treated with simple analgesia, sole
physiotherapy or surgery.
When a patient with one of the above conditions agrees to go ahead with a steroid injection
followed by physiotherapy, the steroid injection is given at the earliest opportunity. The
steroid injection is given into the subacromial space either using the anterolateral
(front-side) approach (1 cm below and behind the anterior edge of the acromion with the
needle aiming towards the under surface of the acromion) or using the posterior (back-side)
approach ( 1cm inferior and medial to the posterlateral acromial edge with the needle
pointing towards the anterolateral aspect of the acromion). The exact approach is determined
according to the preference of the person carrying out the injection. As a routine we use a
10ml syringe containing 10mls of 0.25% Marcaine along with 40mg triamcinolone with an 18
gauge (green) needle. It is normal for patients to complain of some discomfort during the
injection. If a patient experiences any significant discomfort or they cannot tolerate the
injection for whatever reason, then the injection is discontinued and is not reattempted
using a different approach.
Following the injection, patients are questioned on any discomfort experienced during the
injection and on whether or not their pain has improved. They are then taken through a
protocol of physiotherapy for their shoulder over the subsequent 3 months. A protocol is
issued for guidance however therapists are allowed to use other modalities as per their
discretion. The frequency of appointments with physiotherapy will depend on patient's
symptoms as well as their progression. For study purposes a frequency record of these
meetings will be kept and matched to the overall OSS. Patients are seen routinely in 3 months
following an injection in order to assess any improvement in symptomatology using the OSS,
visual analogue score, DASH and SF36 questionaires. If the symptoms have improved then no
further intervention is taken. Further OSS, visual analogue pain score, DASH and SF36
questionaires will be posted out at 6 months and 1 year. On the other hand, if they are still
troubled with symptoms then the possibility of further injections or surgery is discussed.
The aim of this study is to compare the two approaches that are currently used for
subacromial steroid injections, namely the anterolateral and posterior approach, with regards
to their effectiveness in improving shoulder symptoms. There will be no deviation from our
routine protocol other than randomising patients who agree to participate in this study to
either the anterolateral or posterior approach.
In summary, it is patients who are seen in clinic with a subacromial pathology and
subsequently diagnosed with shoulder subacromial pain syndrome, who are offered an injection.
Those who agree to have an injection will then be invited to participate in the study. An
information leaflet will be given to all potential participants and they will be allowed
sufficient time to read through it, digest all the information and ask any questions they may
have before making a decision regarding their participation. Those who agree to participate
will be randomly allocated, using sealed envelopes to one of the two approaches for the
injection. The injection will then be administered via the selected approach by a clinician
who is qualified in carrying out the procedure. Patients will be asked about any discomfort
experienced during the injection, improvement in pain following the injection prior to
leaving hospital and overall satisfaction with the injection. Following this patients will
have physiotherapy as an outpatient as routine and will be seen at about 3 months post
injection for a further assessment at the clinic. Again the shoulder assessment will be
repeated on that occasion. Shoulder assessment questionaires will be posted out for
completion at 6 months and 1 year (OSS, pain on visial analogue scale, DASH and SF36) There
will be no change in patients care from routine practice other than the randomisation of the
approach used for the injection. Patients who are invited to participate in the study and
agree to participate will have their GP informed of their participation.
Assessments
1. Prior to injection: assessment of pain using a visual analogue score, clinical
assessment of shoulder movement and completion of a modified Oxford Shoulder Score,
Disabilities of Shoulder, Arm and Hand questionaires and Short Form 36 Health Survey.
2. 20-30 minutes Post injection: assessment of pain using a visual analogue score
3. Prior to leaving hospital: pain experienced during the administration of the injection
and the overall satisfaction with the injection
4. 3 months post injection: assessment of pain using a visual analogue score, clinical
assessment of shoulder movement and completion of a modified Oxford Shoulder Score,
Disabilities of Shoulder, Arm and Hand questionaires and Short Form 36 Health Survey.
5. 6 months and 1 year post injection: assessment of pain using visual analogue score and
completion of a modified Oxford Shoulder Score, Disabilities of Shoulder, Arm and Hand
questionaires and Short Form 36 Health Survey via post.
The main outcome for this study will be the Oxford Shoulder Score (OSS) at 3 months
post-injection. In addition to the standard OSS, the questionnaire will inquire about general
symptoms and signs, duration, hand dominance, previous injuries to the shoulder and previous
treatments to the shoulder. The follow up questionnaire will be identical to the initial
questionnaire but excluding questions on previous treatments, hand dominance, injuries and
duration.
Other demographics that will be recorded on the pre-designed pro forma include: number and
frequency of physiotherapy sessions pre and post injection, and subsequent need for further
management.
Hard copies of data (questionnaires and forms) collected will be placed into the patient's
notes. At the same time this data will be recorded electronically on an Excel database and
saved on an encrypted, password protected memory stick. This memory stick will be stored in a
locked filing cabinet in the orthopaedic department at Blackpool Victoria Hospital. Please
note: The electronic data will contain NO identifiable information. Participants will be
identified by a unique study I.D number which can only be linked to them by members of the
research team.
