TendonitisNCT00914836
Comparison of 2 Doses of Corticosteroid Subacromial Injections for the Treatment of Painful Shoulder
A study testing Betamethasone Sodium Phosphate, 1 cc - Betamethasone Sodium Phosphate and 2 cc - Betamethasone Sodium Phosphate in people with Tendonitis and Bursitis, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
The use of corticosteroid subacromial injections have been found to be effective for the treatment of shoulder pain. Higher doses may be better than lower doses for subacromial corticosteroid injection for rotator cuff tendonitis. The investigators aim this study to compare 2 doses of corticosteroids. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Tendonitis, Bursitis
- What is being tested?
- Betamethasone Sodium Phosphate, 1 cc - Betamethasone Sodium Phosphate and 2 cc - Betamethasone Sodium Phosphate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2009to Apr 2010
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subacromial bursitis
- tendinitis
- Calcific Tendonitis
Who cannot join
- rotator cuff tear
- osteoarthritis
- pregnancy
- local or systemic infection
- steroid or lidocaine sensitivity
Trial locations and contacts
1 site in 1 country.
About this study
The use of corticosteroid subacromial injections have been found to be effective for the treatment of shoulder pain. Higher doses may be better than lower doses for subacromial corticosteroid injection for rotator cuff tendonitis. The investigators aim this study to compare 2 doses of corticosteroids.
- Conditions
- Tendonitis, Bursitis
- Being tested
- Betamethasone Sodium Phosphate, 1 cc - Betamethasone Sodium Phosphate, 2 cc - Betamethasone Sodium Phosphate
- Keywords
- shoulder, subacromion, corticosteroid, bursitis, tendinitis, calcific tendonitis, subacromial bursitis, rotator cuff tendinitis
- Medical subject headings
- Tendinopathy, Bursitis, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betamethasone Sodium PhosphateDrug
Also called diprospan
1cc:2cc
1 cc - Betamethasone Sodium PhosphateDrug
Also called diprospan
Betamethasone Sodium Phosphate
2 cc - Betamethasone Sodium PhosphateDrug
Also called diprospan
Betamethasone Sodium Phosphate
| Study group | Role | What they receive |
|---|---|---|
| 1 cc - Betamethasone Sodium Phosphate | Active comparator | 1 cc - Betamethasone Sodium Phosphate Receives: Drug: Betamethasone Sodium Phosphate; Drug: 1 cc - Betamethasone Sodium Phosphate |
| 2 cc - Betamethasone Sodium Phosphate | Active comparator | 2 cc - Betamethasone Sodium Phosphate Receives: Drug: Betamethasone Sodium Phosphate; Drug: 2 cc - Betamethasone Sodium Phosphate |
What is being measured
The primary outcome is the main question the study is designed to answer.
constant score
Measured: 9 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: difficulties in the department
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 TendonitisStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914836
- Sponsor's protocol ID
- 19-09
- Status last verified
- Jun 2015
- First submitted
- 17 May 2009
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
van der Heijden GJ, van der Windt DA, Kleijnen J, Koes BW, Bouter LM. Steroid injections for shoulder disorders: a systematic review of randomized clinical trials. Br J Gen Pract. 1996 May;46(406):309-16.
PubMed 8762750
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of 2 Doses of Corticosteroid Subacromial Injections for the Treatment of Painful Shoulder
- ClinicalTrials.gov ID
- NCT00914836
- Acronym / sponsor ID
- 19-09
- Conditions
- Tendonitis, Bursitis
- Keywords
- shoulder, subacromion, corticosteroid, bursitis, tendinitis, calcific tendonitis, subacromial bursitis, rotator cuff tendinitis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: difficulties in the department
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 5 Jun 2009 (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.
The use of corticosteroid subacromial injections have been found to be effective for the treatment of shoulder pain. Higher doses may be better than lower doses for subacromial corticosteroid injection for rotator cuff tendonitis. The investigators aim this study to compare 2 doses of corticosteroids.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 cc - Betamethasone Sodium Phosphate | Active comparator | Drug: Betamethasone Sodium Phosphate, Drug: 1 cc - Betamethasone Sodium Phosphate1 cc - Betamethasone Sodium Phosphate |
| 2 cc - Betamethasone Sodium Phosphate | Active comparator | Drug: Betamethasone Sodium Phosphate, Drug: 2 cc - Betamethasone Sodium Phosphate2 cc - Betamethasone Sodium Phosphate |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subacromial bursitis
- tendinitis
- Calcific Tendonitis
Key exclusion criteria (5 listed)
- rotator cuff tear
- osteoarthritis
- pregnancy
- local or systemic infection
- steroid or lidocaine sensitivity
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 |
|---|---|---|
| Betamethasone Sodium PhosphateAlso: diprospan1cc:2cc | Drug | 1 cc - Betamethasone Sodium Phosphate, 2 cc - Betamethasone Sodium Phosphate |
| 1 cc - Betamethasone Sodium PhosphateAlso: diprospanBetamethasone Sodium Phosphate | Drug | 1 cc - Betamethasone Sodium Phosphate |
| 2 cc - Betamethasone Sodium PhosphateAlso: diprospanBetamethasone Sodium Phosphate | Drug | 2 cc - Betamethasone Sodium Phosphate |
Primary outcome
constant score
Time frame: 9 month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
- Background: PubMed 8762750van der Heijden GJ, van der Windt DA, Kleijnen J, Koes BW, Bouter LM. Steroid injections for shoulder disorders: a systematic review of randomized clinical trials. Br J Gen Pract. 1996 May;46(406):309-16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betamethasone Sodium Phosphate, 1 cc - Betamethasone Sodium Phosphate and 2 cc - Betamethasone Sodium Phosphate in people with Tendonitis and Bursitis, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 3 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: withdrawn, as of the sponsor's last update on 23 Jun 2015. 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 Israel. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
constant score (time frame: 9 month). 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 NCT00914836, 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 23 Jun 2015.