Frozen ShoulderPhase 4TIFFSNCT04965376
A Trial Comparing Glenohumeral Joint Steroid Injection Versus Suprascapular Nerve Block in Patients With Frozen Shoulder
A Phase 4 study testing Glenohumeral joint steroid injection and Suprascapular nerve block steroid injection in people with Frozen Shoulder, run by Blackpool Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Frozen Shoulder
- What is being tested?
- Glenohumeral joint steroid injection and Suprascapular nerve block steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2021to Aug 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than or equal to 18 years
- Patient diagnosed with unilateral frozen shoulder (Diagnosis of frozen shoulder will be based on clinical examination (restriction of passive external rotation in the affected shoulder > 50% compared to opposite site), in the presence of normal plain radiographs (antero-posterior and axillary projections) (other than calcific tendinopathy))
Who cannot join
- Age less than 18 years
- Lacking capacity/unable to give valid consent for participation
- Full thickness rotator cuff tear diagnosed on either Ultrasound scan or Magnetic Resonance Imaging
- Unable to complete follow up
- Unable to speak or read English
- Allergy to corticosteroid or local anaesthetic
- Simultaneous bilateral frozen shoulder.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Blackpool Victoria Hospitals NHS Foundation Trust
Blackpool, Lancashire, FY3 8NR
Charalambos P Charalambous, 01253 300000, mr.charalambous@nhs.net
About this study
Official title: Therapeutic Injections for Frozen Shoulder (TIFFS Study)- Comparing Suprascapular Nerve Block Versus Intra-articular Glenohumeral Joint Injection. A Randomised Controlled Trial
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.
Read the detailed 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.
- Conditions
- Frozen Shoulder
- Being tested
- Glenohumeral joint steroid injection, Suprascapular nerve block steroid injection
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glenohumeral joint steroid injectionProcedure or surgery
Ultrasound guided steroid injection into the glenohumeral joint (10mls of 1% lidocaine with 40mg depo-medrone)
Suprascapular nerve block steroid injectionProcedure or surgery
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)
| Study group | Role | What they receive |
|---|---|---|
| Glenohumeral joint injection | Active comparator | Ultrasound guided steroid injection into the glenohumeral joint (10mls of 1% lidocaine with 40mg depo-medrone) Receives: Procedure: Glenohumeral joint steroid injection |
| Suprascapular nerve block | Active comparator | 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) Receives: Procedure: Suprascapular nerve block steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxford Shoulder Score (OSS) (Scored 12-60, higher score means worse outcome)
Patient will complete in clinic
Measured: 3 months post-injection
Secondary outcomes (4)
Oxford Shoulder Score (Scored 12-60, higher score means worse outcome)
Patient will complete over telephone/by post
Measured: 6 months and 12 months post-injection
Pain Numeric Rating Scale (Scored 0-10, higher score means worse outcome)
Patient will complete over telephone/by post
Measured: 3 months, 6 months and 12 months post-injection
Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) (Scored 0-100, higher score means worse outcome)
Patient will complete over telephone/by post
Measured: 3 months, 6 months and 12 months post-injection
EuroQol-5 Dimension-5 level (EQ-5D-5L)(, First part does not have min or max values and not scored on numerical scale. EQ VAS part is scored 0-100, high score means better outcome)
Patient will complete over telephone/by post
Measured: 3 months, 6 months and 12 months post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start1 Aug 2021
- Primary completionAug 2024 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frozen ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Ultrasound guided steroid injection into the glenohumeral joint versus ultrasound guided suprascapular nerve block
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blackpool Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charalambos Charalambous, Blackpool Teaching Hospitals NHS Foundation Trust
- Investigators
- Charalambos P Charalambous, Principal investigator, Blackpool Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04965376
- Sponsor's protocol ID
- Pending
- Acronym
- TIFFS
- Status last verified
- Sep 2023
- First submitted
- 7 Jul 2021
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be published in peer review journal on completion of the study.
Publications
Jump CM, Mati W, Maley A, Taylor R, Gratrix K, Blundell C, Lane S, Solanki N, Khan M, Choudhry M, Shetty V, Malik RA, Charalambous CP. A randomized clinical trial of glenohumeral joint steroid injection versus suprascapular nerve block in patients with frozen shoulder: a protocol for the Therapeutic Injections For Frozen Shoulder (TIFFS) study. Bone Jt Open. 2023 Mar 16;4(3):205-209. doi: 10.1302/2633-1462.43.BJO-2022-0066.R1.
PubMed 37051821
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Injections for Frozen Shoulder (TIFFS Study)- Comparing Suprascapular Nerve Block Versus Intra-articular Glenohumeral Joint Injection. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04965376
- Acronym / sponsor ID
- TIFFS / Pending
- Conditions
- Frozen Shoulder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Blackpool Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 16 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Ultrasound guided steroid injection into the glenohumeral joint versus ultrasound guided suprascapular nerve block
| Arm | Type | Receives |
|---|---|---|
| Glenohumeral joint injection | Active comparator | Procedure: Glenohumeral joint steroid injectionUltrasound guided steroid injection into the glenohumeral joint (10mls of 1% lidocaine with 40mg depo-medrone) |
| Suprascapular nerve block | Active comparator | Procedure: Suprascapular nerve block steroid injectionUltrasound 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age greater than or equal to 18 years
- Patient diagnosed with unilateral frozen shoulder (Diagnosis of frozen shoulder will be based on clinical examination (restriction of passive external rotation in the affected shoulder > 50% compared to opposite site), in the presence of normal plain radiographs (antero-posterior and axillary projections) (other than calcific tendinopathy))
Key exclusion criteria (7 listed)
- Age less than 18 years
- Lacking capacity/unable to give valid consent for participation
- Full thickness rotator cuff tear diagnosed on either Ultrasound scan or Magnetic Resonance Imaging
- Unable to complete follow up
- Unable to speak or read English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glenohumeral joint steroid injectionUltrasound guided steroid injection into the glenohumeral joint (10mls of 1% lidocaine with 40mg depo-medrone) | Procedure or surgery | Glenohumeral joint injection |
| Suprascapular nerve block steroid injectionUltrasound 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) | Procedure or surgery | Suprascapular nerve block |
Primary outcome
Oxford Shoulder Score (OSS) (Scored 12-60, higher score means worse outcome)
Time frame: 3 months post-injection
Patient will complete in clinic
4 secondary outcomes
Oxford Shoulder Score (Scored 12-60, higher score means worse outcome)
Time frame: 6 months and 12 months post-injection
Pain Numeric Rating Scale (Scored 0-10, higher score means worse outcome)
Time frame: 3 months, 6 months and 12 months post-injection
Quick Disabilities of Arm, Shoulder and Hand (QuickDASH) (Scored 0-100, higher score means worse outcome)
Time frame: 3 months, 6 months and 12 months post-injection
EuroQol-5 Dimension-5 level (EQ-5D-5L)(, First part does not have min or max values and not scored on numerical scale. EQ VAS part is scored 0-100, high score means better outcome)
Time frame: 3 months, 6 months and 12 months post-injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 37051821Jump CM, Mati W, Maley A, Taylor R, Gratrix K, Blundell C, Lane S, Solanki N, Khan M, Choudhry M, Shetty V, Malik RA, Charalambous CP. A randomized clinical trial of glenohumeral joint steroid injection versus suprascapular nerve block in patients with frozen shoulder: a protocol for the Therapeutic Injections For Frozen Shoulder (TIFFS) study. Bone Jt Open. 2023 Mar 16;4(3):205-209. doi: 10.1302/2633-1462.43.BJO-2022-0066.R1.
- Individual participant dataSharing planned: No. Data will be published in peer review journal on completion of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charalambos P Charalambous principal investigator
Blackpool Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glenohumeral joint steroid injection and Suprascapular nerve block steroid injection in people with Frozen Shoulder, run by Blackpool Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Charalambos P Charalambous (01253 300000, mr.charalambous@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxford Shoulder Score (OSS) (Scored 12-60, higher score means worse outcome) (time frame: 3 months post-injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04965376, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.