Rotator Cuff DiseaseNCT00640575
Subacromial Ultrasound-guided or Systemic Steroid Injection for Rotator Cuff Disease, a Randomized Double Blinded Study
A study testing triamcinolone and lidocaine hydrochloride in people with Rotator Cuff Disease, run by Ullevaal University Hospital.
Trial summary
Corticosteroid injections is a popular treatment option in shoulder disease. The evidence of effectiveness of corticosteroid injections is however contradicting. The importance of the accuracy of the steroid placement have been discussed and recently there are a few studies indicating better treatment effect if the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Disease
- What is being tested?
- triamcinolone and lidocaine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- No sites listed yet
- Study dates
- Mar 2005to Dec 2006
- Phase
- Interventional
- 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
- above 18 years
- shoulder pain for more than 3 months
- pain at abduction of the affected shoulder
- less than 50 % reduced passive glenohumeral range of motion in no more than one direction of either abduction, external or internal rotation
- 2 of 3 positive isometric test of external rotation, internal rotation and abduction
- positive Hawkins-Kennedy impingement test
Who cannot join
- SPADI score below 30 points
- symptomatic acromioclavicular arthritis
- clinical and radiological findings indicating glenohumeral joint pathology
- referred pain from neck or internal organs
- clinical signs of a cervical syndrome
- generalized muscular pain syndrome with bilateral muscular pain in the neck and shoulders
Show all 11Show fewer
- history of inflammatory arthritis
- diabetes mellitus type 1
- contraindications to local steroid or lidocaine hydrochloride injections
- corticosteroid injections last month before inclusion
- unable to respond to questionnaires
About this study
Corticosteroid injections is a popular treatment option in shoulder disease. The evidence of effectiveness of corticosteroid injections is however contradicting. The importance of the accuracy of the steroid placement have been discussed and recently there are a few studies indicating better treatment effect if the injections are guided towards specific anatomical structures by real time ultrasound imaging. None of these studies have been double blinded. The aim of this study is to investigate the importance of placement of steroid injection in patients with rotator cuff disease by comparing systemic and ultrasound-guided injection in the subacromial bursa using a double blinded design.
- Conditions
- Rotator Cuff Disease
- Being tested
- triamcinolone and lidocaine hydrochloride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
triamcinolone and lidocaine hydrochlorideDrug
Also called Xyloacain (AstraZeneca), Kenakort-T (Bristol-Myers Squibb)
Ultrasound-guided lidocaine hydrochloride 5 ml (10 mg/ml) injection in the subacromial bursa and a triamcinolone 2 ml (10 mg/ml) and 2 ml lidocaine hydrochloride (10 mg/ml) intramuscular injection in the gluteal region
triamcinolone and lidocaine hydrochlorideDrug
Also called Kenacort-T (Bristol-Myers Squibb), Xylocain (AstraZeneca)
Ultrasound-guided injection of 2 ml triamcinolone (10 mg/ml) and 5 ml lidocaine hydrochloride (10 mg/ml) in the subacromial bursa and 4 ml intramuscular injection of lidocaine hydrochloride in the gluteal region
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Local Receives: Drug: triamcinolone and lidocaine hydrochloride |
| B | Active comparator | Systemic Receives: Drug: triamcinolone and lidocaine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index (SPADI)
Measured: 2 and 6 weeks
Secondary outcomes (5)
Western Ontario Rotator Cuff Index (WORC)
Measured: 2 and 6 weeks
Pain in activity (7 point ordinal scale)
Measured: 2 and 6 weeks
Pain at rest (7 point ordinal scale)
Measured: 2 and 6 weeks
Change in main complaint (18 point ordinal scale)
Measured: 2 and 6 weeks
Active range of motion
Measured: 2 and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2008 (estimated)
- Study startMar 2005
- Primary completionOct 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff DiseaseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Investigators
- Ole M Ekeberg, MD, Principal investigator, University of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00640575
- Sponsor's protocol ID
- sais-201204
- Status last verified
- Mar 2005
- First submitted
- 9 Mar 2008
- Last updated
- 6 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ekeberg OM, Bautz-Holter E, Juel NG, Engebretsen K, Kvalheim S, Brox JI. Clinical, socio-demographic and radiological predictors of short-term outcome in rotator cuff disease. BMC Musculoskelet Disord. 2010 Oct 15;11:239. doi: 10.1186/1471-2474-11-239.
PubMed 20950433Ekeberg OM, Bautz-Holter E, Tveita EK, Juel NG, Kvalheim S, Brox JI. Subacromial ultrasound guided or systemic steroid injection for rotator cuff disease: randomised double blind study. BMJ. 2009 Jan 23;338:a3112. doi: 10.1136/bmj.a3112.
PubMed 19168537
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subacromial Ultrasound-guided or Systemic Steroid Injection for Rotator Cuff Disease, a Randomized Double Blinded Study
- ClinicalTrials.gov ID
- NCT00640575
- Acronym / sponsor ID
- sais-201204
- Conditions
- Rotator Cuff Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- Mar 2005
- Primary completion
- Oct 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 21 Mar 2008 (estimated)
- 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.
Corticosteroid injections is a popular treatment option in shoulder disease. The evidence of effectiveness of corticosteroid injections is however contradicting. The importance of the accuracy of the steroid placement have been discussed and recently there are a few studies indicating better treatment effect if the injections are guided towards specific anatomical structures by real time ultrasound imaging. None of these studies have been double blinded. The aim of this study is to investigate the importance of placement of steroid injection in patients with rotator cuff disease by comparing systemic and ultrasound-guided injection in the subacromial bursa using a double blinded design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: triamcinolone and lidocaine hydrochlorideLocal |
| B | Active comparator | Drug: triamcinolone and lidocaine hydrochlorideSystemic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- above 18 years
- shoulder pain for more than 3 months
- pain at abduction of the affected shoulder
- less than 50 % reduced passive glenohumeral range of motion in no more than one direction of either abduction, external or internal rotation
- 2 of 3 positive isometric test of external rotation, internal rotation and abduction
Key exclusion criteria (11 listed)
- SPADI score below 30 points
- symptomatic acromioclavicular arthritis
- clinical and radiological findings indicating glenohumeral joint pathology
- referred pain from neck or internal organs
- clinical signs of a cervical syndrome
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 |
|---|---|---|
| triamcinolone and lidocaine hydrochlorideAlso: Xyloacain (AstraZeneca), Kenakort-T (Bristol-Myers Squibb)Ultrasound-guided lidocaine hydrochloride 5 ml (10 mg/ml) injection in the subacromial bursa and a triamcinolone 2 ml (10 mg/ml) and 2 ml lidocaine hydrochloride (10 mg/ml) intramuscular injection in the gluteal region | Drug | B |
| triamcinolone and lidocaine hydrochlorideAlso: Kenacort-T (Bristol-Myers Squibb), Xylocain (AstraZeneca)Ultrasound-guided injection of 2 ml triamcinolone (10 mg/ml) and 5 ml lidocaine hydrochloride (10 mg/ml) in the subacromial bursa and 4 ml intramuscular injection of lidocaine hydrochloride in the gluteal region | Drug | A |
Primary outcome
Shoulder Pain and Disability Index (SPADI)
Time frame: 2 and 6 weeks
5 secondary outcomes
Western Ontario Rotator Cuff Index (WORC)
Time frame: 2 and 6 weeks
Pain in activity (7 point ordinal scale)
Time frame: 2 and 6 weeks
Pain at rest (7 point ordinal scale)
Time frame: 2 and 6 weeks
Change in main complaint (18 point ordinal scale)
Time frame: 2 and 6 weeks
Active range of motion
Time frame: 2 and 6 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 6 Jul 2011.
- Derived from this study: PubMed 20950433Ekeberg OM, Bautz-Holter E, Juel NG, Engebretsen K, Kvalheim S, Brox JI. Clinical, socio-demographic and radiological predictors of short-term outcome in rotator cuff disease. BMC Musculoskelet Disord. 2010 Oct 15;11:239. doi: 10.1186/1471-2474-11-239.
- Derived from this study: PubMed 19168537Ekeberg OM, Bautz-Holter E, Tveita EK, Juel NG, Kvalheim S, Brox JI. Subacromial ultrasound guided or systemic steroid injection for rotator cuff disease: randomised double blind study. BMJ. 2009 Jan 23;338:a3112. doi: 10.1136/bmj.a3112.
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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.
Ole M Ekeberg, MD principal investigator
University of Oslo
Questions about this trial
What is this clinical trial studying?
A study testing triamcinolone and lidocaine hydrochloride in people with Rotator Cuff Disease, run by Ullevaal University 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 6 inclusion and 11 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 6 Jul 2011. 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.
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?
Shoulder Pain and Disability Index (SPADI) (time frame: 2 and 6 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 NCT00640575, which also lists 2 linked publications.
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 6 Jul 2011.