Impingement ShoulderPhase 4NCT03120923
Combined Corticosteroid With Low Volume Compared to High Volume in Impingement Syndrome
A Phase 4 study testing Lidocaine 3 cc, Lidocaine 9 cc and Triamcinolone Acetonide in people with Impingement Shoulder, run by Ramathibodi Hospital.
Trial summary
This study aims to assess and compare the effectiveness of two different volumes of local anesthetic combined with 40mg of triamcinolone for subacromial injections in treating patients with rotator cuff impingement syndrome Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Impingement Shoulder
- What is being tested?
- Lidocaine 3 cc, Lidocaine 9 cc and Triamcinolone Acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2015to 1 Aug 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants with clinically diagnosed the rotator cuff impingement
- participants aged 20 years and older
- at least 1 month's duration
- pain of moderate to severe intensity, defined as a score of 5 or more points on a 10-cm visual analog scale (VAS) rated from 0 (no pain) to 10 (worst imaginable pain)
Who cannot join
- patients with adhesive capsulitis of the shoulder (normal radiograph of affected shoulder, and restriction of passive motion >30° in ≥2 planes of movement)
- previous trauma history at currently affected shoulder
- previous corticosteroid injection history at the affected shoulder
- abnormal calcification and/or primary osteoarthritis of the shoulder joint on plain radiographs
- use of medication such as antiplatelet agent or anticoagulation.
About this study
Official title: A Short Term Outcomes of Subacromial Injection of Combined Corticosteroid With Low Volume Compared to High Volume of Local Anesthetic for Rotator Cuff Impingement Syndrome: A Randomized Controlled Trials
This study aims to assess and compare the effectiveness of two different volumes of local anesthetic combined with 40mg of triamcinolone for subacromial injections in treating patients with rotator cuff impingement syndrome
Read the detailed description
Patients with rotator cuff impingement syndrome were randomized to undergo subacromial injection with 10mL total volume of 1% lidocaine plus 40mg triamcinolone acetonide (n = 22), or a 4mL total volume of 1% lidocaine plus 40-mg triamcinolone acetonide (n = 23). Evaluations using a visual analog scale (VAS) for pain during motion, and the Western Ontario Rotator Cuff Index (WORC) were completed before treatment and 30 minutes, 2 weeks, and 8 weeks after injection.
- Conditions
- Impingement Shoulder
- Being tested
- Lidocaine 3 cc, Lidocaine 9 cc, Triamcinolone Acetonide
- Keywords
- subacromial injection
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine 3 ccDrug
Lidocaine 9 ccDrug
9mL of 1% lidocaine plus 1mL of 40mg triamcinolone acetonide
Triamcinolone AcetonideDrug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine 3 cc & Triamcinolone Acetonide | Experimental | Not described Receives: Drug: Lidocaine 3 cc; Drug: Triamcinolone Acetonide |
| Lidocaine 9cc & Triamcinolone Acetonide | Active comparator | Not described Receives: Drug: Lidocaine 9 cc; Drug: Triamcinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
Visual analog score
Measured: 8 weeks
Secondary outcomes (2)
WORC
Western Ontario Rotator Cuff Index
Measured: 8 weeks
Adverse reaction
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2017
- Study start1 Jan 2015
- Primary completion1 Aug 2016
- Study completion1 Aug 2016
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 Impingement 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Khon Kaen University
- Responsible party
- Principal investigator, Jatupon Kongtharvonskul, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03120923
- Sponsor's protocol ID
- HE551338
- Status last verified
- Oct 2017
- First submitted
- 16 Apr 2017
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Boonard M, Sumanont S, Arirachakaran A, Apiwatanakul P, Boonrod A, Kanchanatawan W, Kongtharvonskul J. Short-term outcomes of subacromial injection of combined corticosteroid with low-volume compared to high-volume local anesthetic for rotator cuff impingement syndrome: a randomized controlled non-inferiority trial. Eur J Orthop Surg Traumatol. 2018 Aug;28(6):1079-1087. doi: 10.1007/s00590-018-2149-3. Epub 2018 Feb 8.
PubMed 29423865
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Short Term Outcomes of Subacromial Injection of Combined Corticosteroid With Low Volume Compared to High Volume of Local Anesthetic for Rotator Cuff Impingement Syndrome: A Randomized Controlled Trials
- ClinicalTrials.gov ID
- NCT03120923
- Acronym / sponsor ID
- HE551338
- Conditions
- Impingement Shoulder
- Keywords
- subacromial injection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Collaborators
- Khon Kaen University
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Aug 2016 (actual)
- Study completion
- 1 Aug 2016 (actual)
- First posted
- 19 Apr 2017 (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.
This study aims to assess and compare the effectiveness of two different volumes of local anesthetic combined with 40mg of triamcinolone for subacromial injections in treating patients with rotator cuff impingement syndrome
Detailed description
Patients with rotator cuff impingement syndrome were randomized to undergo subacromial injection with 10mL total volume of 1% lidocaine plus 40mg triamcinolone acetonide (n = 22), or a 4mL total volume of 1% lidocaine plus 40-mg triamcinolone acetonide (n = 23). Evaluations using a visual analog scale (VAS) for pain during motion, and the Western Ontario Rotator Cuff Index (WORC) were completed before treatment and 30 minutes, 2 weeks, and 8 weeks after injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine 3 cc & Triamcinolone Acetonide | Experimental | Drug: Lidocaine 3 cc, Drug: Triamcinolone Acetonide |
| Lidocaine 9cc & Triamcinolone Acetonide | Active comparator | Drug: Lidocaine 9 cc, Drug: Triamcinolone Acetonide |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- participants with clinically diagnosed the rotator cuff impingement
- participants aged 20 years and older
- at least 1 month's duration
- pain of moderate to severe intensity, defined as a score of 5 or more points on a 10-cm visual analog scale (VAS) rated from 0 (no pain) to 10 (worst imaginable pain)
Key exclusion criteria (5 listed)
- patients with adhesive capsulitis of the shoulder (normal radiograph of affected shoulder, and restriction of passive motion >30° in ≥2 planes of movement)
- previous trauma history at currently affected shoulder
- previous corticosteroid injection history at the affected shoulder
- abnormal calcification and/or primary osteoarthritis of the shoulder joint on plain radiographs
- use of medication such as antiplatelet agent or anticoagulation.
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 |
|---|---|---|
| Lidocaine 3 cc | Drug | Lidocaine 3 cc & Triamcinolone Acetonide |
| Lidocaine 9 cc9mL of 1% lidocaine plus 1mL of 40mg triamcinolone acetonide | Drug | Lidocaine 9cc & Triamcinolone Acetonide |
| Triamcinolone Acetonide | Drug | Lidocaine 3 cc & Triamcinolone Acetonide, Lidocaine 9cc & Triamcinolone Acetonide |
Primary outcome
VAS
Time frame: 8 weeks
Visual analog score
2 secondary outcomes
WORC
Time frame: 8 weeks
Adverse reaction
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2017.
- Derived from this study: PubMed 29423865Boonard M, Sumanont S, Arirachakaran A, Apiwatanakul P, Boonrod A, Kanchanatawan W, Kongtharvonskul J. Short-term outcomes of subacromial injection of combined corticosteroid with low-volume compared to high-volume local anesthetic for rotator cuff impingement syndrome: a randomized controlled non-inferiority trial. Eur J Orthop Surg Traumatol. 2018 Aug;28(6):1079-1087. doi: 10.1007/s00590-018-2149-3. Epub 2018 Feb 8.
- Individual participant dataSharing planned: Undecided
Related trials for Impingement Shoulder
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
RecruitingObservational study
Pain Phenotype and Response to Corticosteroid Injection in Patients With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
RecruitingObservational study
Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
Subacromial Pain Syndrome, Rotator Cuff Related Shoulder Pain
Not yet recruiting
Effects of Different Kinesio Taping Methods in Subacromial Impingement Syndrome
Subacromial Impingement Syndrome
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine 3 cc, Lidocaine 9 cc and Triamcinolone Acetonide in people with Impingement Shoulder, run by Ramathibodi Hospital.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 18 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS (time frame: 8 weeks). 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 NCT03120923, 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 18 Oct 2017; AzTrials last refreshed its copy on 2 Nov 2026.