Adhesive CapsulitisNCT00840229
Rotator Interval and Intra-articular Corticosteroid Injection for Frozen Shoulder
A study testing Triamcinolone hexacetonide in people with Adhesive Capsulitis, run by Oslo University Hospital at 1 site in Norway.
Trial summary
The purpose of this study is to compare ultrasound guided capsular corticosteroid injection into the rotator interval/anterior capsule and the GH joint with ultrasound guided corticosteroid injection into the GH joint only. Both methods will be compared with placebo injections. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Triamcinolone hexacetonide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2009to Jun 2012
- 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 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pain and stiffness in one shoulder 1 - 6 months
- Restriction of passive ROM; >= 30 degrees in two or more planes compared to other shoulder
Who cannot join
- Systemic inflammatory disease
- Corticosteroid treatment last 3 months
- Poorly controlled Diabetes mellitus
- Pregnancy
- Contraindications/allergy to corticosteroids and/or Lidocaine
- Severe infections
Show all 11Show fewer
- Osteoarthritis of the shoulder
- Fractures of the shoulder
- Rotator cuff pathology causing pain or disability
- Fibromyalgia
- Not able to understand Norwegian
Trial locations and contacts
1 site in 1 country.
Norway1 site
Vestfold Hospitalt Trust, Clinic Physical Medicine and Rehabilitation
Stavern, 3294
About this study
Official title: Rotator Interval and Intra-articular Corticosteroid Injection for Adhesive Capsulitis (Frozen Shoulder): a Randomised, Double Blind, Placebo Controlled Trial
The purpose of this study is to compare ultrasound guided capsular corticosteroid injection into the rotator interval/anterior capsule and the GH joint with ultrasound guided corticosteroid injection into the GH joint only. Both methods will be compared with placebo injections.
Primary outcome measure: pain reduction at week 6 Secondary outcome measures: improvement of function (SPADI, Life quality, ROM).
0-hypothesis: no difference between the methods.
The investigators want to find out if the clinical effect of the combined capsular and intra-articular injections are better than placebo and better that intra-articular injections
Read the detailed description
3 groups, 50 patients in each, follow-up visits after 3, 6, 12 and 26 weeks.
- Conditions
- Adhesive Capsulitis
- Being tested
- Triamcinolone hexacetonide
- Keywords
- adhesive capsulitis, corticosteroids, injection, pain
- Medical subject headings
- Bursitis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone hexacetonideDrug
20 mg
Triamcinolone hexacetonideDrug
1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml
| Study group | Role | What they receive |
|---|---|---|
| 1 capsular & intra-articular | Experimental | corticosteroid injection (Triamcinolone) in capsule/rotator interval and intra-articular Receives: Drug: Triamcinolone hexacetonide |
| 2 intra-articular | Active comparator | corticosteroid injection (Triamcinolone) intra-articular placebo injection (Lidocaine) in capsule Receives: Drug: Triamcinolone hexacetonide |
| 3 placebo | Placebo comparator | placebo injections (Lidocaine) in capsule and intra-articular Receives: Drug: Triamcinolone hexacetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain reduction
Measured: 2-3 years
Secondary outcomes (1)
Function (ROM, SPADI), Life quality
Measured: 2-3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJun 2012
- Study completionJun 2012
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 Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tore Prestegaard, Sykehuset i Vestfold HF
- Investigators
- Tore A Prestgaard, MD, Principal investigator, The Hospital of Vestfold
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840229
- Sponsor's protocol ID
- S-08546
- Other IDs
- REK, Interne tjenester, IT-avdelingen, Rikshospitalet HF
- Status last verified
- Nov 2013
- First submitted
- 8 Feb 2009
- Last updated
- 26 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Prestgaard T, Wormgoor MEA, Haugen S, Harstad H, Mowinckel P, Brox JI. Ultrasound-guided intra-articular and rotator interval corticosteroid injections in adhesive capsulitis of the shoulder: a double-blind, sham-controlled randomized study. Pain. 2015 Sep;156(9):1683-1691. doi: 10.1097/j.pain.0000000000000209.
PubMed 25919473
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotator Interval and Intra-articular Corticosteroid Injection for Adhesive Capsulitis (Frozen Shoulder): a Randomised, Double Blind, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT00840229
- Acronym / sponsor ID
- S-08546
- Conditions
- Adhesive Capsulitis
- Keywords
- adhesive capsulitis, corticosteroids, injection, pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 10 Feb 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 purpose of this study is to compare ultrasound guided capsular corticosteroid injection into the rotator interval/anterior capsule and the GH joint with ultrasound guided corticosteroid injection into the GH joint only. Both methods will be compared with placebo injections.
Primary outcome measure: pain reduction at week 6 Secondary outcome measures: improvement of function (SPADI, Life quality, ROM).
0-hypothesis: no difference between the methods.
The investigators want to find out if the clinical effect of the combined capsular and intra-articular injections are better than placebo and better that intra-articular injections
Detailed description
3 groups, 50 patients in each, follow-up visits after 3, 6, 12 and 26 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 capsular & intra-articular | Experimental | Drug: Triamcinolone hexacetonidecorticosteroid injection (Triamcinolone) in capsule/rotator interval and intra-articular |
| 2 intra-articular | Active comparator | Drug: Triamcinolone hexacetonidecorticosteroid injection (Triamcinolone) intra-articular placebo injection (Lidocaine) in capsule |
| 3 placebo | Placebo comparator | Drug: Triamcinolone hexacetonideplacebo injections (Lidocaine) in capsule and intra-articular |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pain and stiffness in one shoulder 1 - 6 months
- Restriction of passive ROM; >= 30 degrees in two or more planes compared to other shoulder
Key exclusion criteria (11 listed)
- Systemic inflammatory disease
- Corticosteroid treatment last 3 months
- Poorly controlled Diabetes mellitus
- Pregnancy
- Contraindications/allergy to corticosteroids and/or Lidocaine
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 hexacetonide20 mg | Drug | 3 placebo |
| Triamcinolone hexacetonide1 ml (20 mg) + 6 ml Lidocaine 10 mg/ml | Drug | 1 capsular & intra-articular, 2 intra-articular |
Primary outcome
Pain reduction
Time frame: 2-3 years
1 secondary outcome
Function (ROM, SPADI), Life quality
Time frame: 2-3 years
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 26 Nov 2013.
- Derived from this study: PubMed 25919473Prestgaard T, Wormgoor MEA, Haugen S, Harstad H, Mowinckel P, Brox JI. Ultrasound-guided intra-articular and rotator interval corticosteroid injections in adhesive capsulitis of the shoulder: a double-blind, sham-controlled randomized study. Pain. 2015 Sep;156(9):1683-1691. doi: 10.1097/j.pain.0000000000000209.
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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.
Tore A Prestgaard, MD principal investigator
The Hospital of Vestfold
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triamcinolone hexacetonide in people with Adhesive Capsulitis, run by Oslo University Hospital at 1 site in Norway.
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 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 26 Nov 2013. 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 Norway. 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. Some participants in this study may receive a placebo. 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?
Pain reduction (time frame: 2-3 years). 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 NCT00840229, 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 26 Nov 2013.