Adhesive CapsulitisNCT01029600
Surgery or Capsular Distention With Steroid in the Treatment of Primary Frozen Shoulder?
A study testing Arthroscopic capsular release and Distention with steroid in people with Adhesive Capsulitis, run by Bergen Surgical Hospital at 1 site in Norway.
Trial summary
The purpose of the study is to compare two different treatment regimens for primary frozen shoulder: Arthroscopic capsulotomy and arthrographic distention with steroid. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Arthroscopic capsular release and Distention with steroid
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2009to Apr 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must have understood all information about the project and must have signed the informed consent letter about participation in the study including rehabilitation and follow-up
- The patients must have a history and clinical findings typical for primary frozen shoulder with globally reduced range of motion in the shoulder.
- External rotation 20 degrees or less
- Abduction 45 degrees or less
- The patients must not be in phase 1 (inflammation phase)
- Diabetics may be included
- MRI must be taken to exclude other reasons for stiffness
Who cannot join
- Other reasons for stiffness( cuff rupture, arthritis)
- Posttraumatic or postoperative stiffness
- Patients not suited for day surgery
- Patients with a history of subacromial impingement before developing stiffness
Trial locations and contacts
1 site in 1 country.
Jannike Øyen, M Sc contact
Norway1 site, 1 recruiting
- Recruiting
Haraldsplass Deaconess Hospital
Bergen, Hordaland, 5009
Jesper Blomquist, MD, +4755978500, jblo@haraldsplass.no
About this study
Official title: Arthroscopic Capsulotomy vs Arthrographic Distention With Steroid in the Treatment of Primary Frozen Shoulder. A Randomized Study
The purpose of the study is to compare two different treatment regimens for primary frozen shoulder: Arthroscopic capsulotomy and arthrographic distention with steroid.
Read the detailed description
Patients with primary frozen shoulder will be randomized to two different treatments and the outcome will be measured.
- Conditions
- Adhesive Capsulitis
- Being tested
- Arthroscopic capsular release, Distention with steroid
- Keywords
- Randomized study capsulotomy vs distention with steroid
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthroscopic capsular releaseProcedure or surgery
Surgical division of thickened capsule in the shoulder
Distention with steroidProcedure or surgery
Intraarticular distention with steroid, saline, contrast and local anaesthetic
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic Capsulotomy | Active comparator | Arthroscopic capsular release Receives: Procedure: Arthroscopic capsular release |
| Distention with steroid | Active comparator | Arthrographic distention with contrast, saline, steroid and local anaesthetic Receives: Procedure: Distention with steroid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Function
Measured: 2 years
Secondary outcomes (1)
Shoulder range of motion
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionMar 2012 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Adhesive CapsulitisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bergen Surgical Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Haraldsplass Deaconess Hospital, Haukeland University Hospital
- Investigators
- Eirik J Solheim, MD, PhD, Study chair, University of Bergen, Surgical Dept.Leiv Hove, MD, PhD, Study director, University of Bergen, Surgical Dept.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029600
- Sponsor's protocol ID
- 2009/870
- Status last verified
- Dec 2009
- First submitted
- 9 Dec 2009
- Last updated
- 16 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Codman EA. The Shoulder: Rupture of the Supraspinatus Tendon and Other Lesions In or About the Subacromial Bursa. Boston: Thomas Todd Co; 1934.
Bridgman JF. Periarthritis of the shoulder and diabetes mellitus. Ann Rheum Dis. 1972 Jan;31(1):69-71. doi: 10.1136/ard.31.1.69. No abstract available.
PubMed 5008469Moren-Hybbinette I, Moritz U, Schersten B. The clinical picture of the painful diabetic shoulder--natural history, social consequences and analysis of concomitant hand syndrome. Acta Med Scand. 1987;221(1):73-82. doi: 10.1111/j.0954-6820.1987.tb01247.x.
PubMed 2436441Grey RG. The natural history of "idiopathic" frozen shoulder. J Bone Joint Surg Am. 1978 Jun;60(4):564. No abstract available.
PubMed 670287Reeves B. The natural history of the frozen shoulder syndrome. Scand J Rheumatol. 1975;4(4):193-6. doi: 10.3109/03009747509165255.
PubMed 1198072Binder AI, Bulgen DY, Hazleman BL, Roberts S. Frozen shoulder: a long-term prospective study. Ann Rheum Dis. 1984 Jun;43(3):361-4. doi: 10.1136/ard.43.3.361.
PubMed 6742896Duplay ES. De la periarthrite scapulo-humérale et des raideurs de l'épaule qui en sont la conséquence. Arch Gen Med 1872;20:513-42.
Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.
PubMed 16356983Shaffer B, Tibone JE, Kerlan RK. Frozen shoulder. A long-term follow-up. J Bone Joint Surg Am. 1992 Jun;74(5):738-46.
PubMed 1624489Pal B, Anderson J, Dick WC, Griffiths ID. Limitation of joint mobility and shoulder capsulitis in insulin- and non-insulin-dependent diabetes mellitus. Br J Rheumatol. 1986 May;25(2):147-51. doi: 10.1093/rheumatology/25.2.147.
PubMed 3708230Bunker TD, Anthony PP. The pathology of frozen shoulder. A Dupuytren-like disease. J Bone Joint Surg Br. 1995 Sep;77(5):677-83.
PubMed 7559688
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arthroscopic Capsulotomy vs Arthrographic Distention With Steroid in the Treatment of Primary Frozen Shoulder. A Randomized Study
- ClinicalTrials.gov ID
- NCT01029600
- Acronym / sponsor ID
- 2009/870
- Conditions
- Adhesive Capsulitis
- Keywords
- Randomized study capsulotomy vs distention with steroid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Bergen Surgical HospitalUniversity, hospital or other
- Collaborators
- Haraldsplass Deaconess Hospital, Haukeland University Hospital
- Study start
- Dec 2009
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 10 Dec 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 the study is to compare two different treatment regimens for primary frozen shoulder: Arthroscopic capsulotomy and arthrographic distention with steroid.
Detailed description
Patients with primary frozen shoulder will be randomized to two different treatments and the outcome will be measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic Capsulotomy | Active comparator | Procedure: Arthroscopic capsular releaseArthroscopic capsular release |
| Distention with steroid | Active comparator | Procedure: Distention with steroidArthrographic distention with contrast, saline, steroid and local anaesthetic |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The patient must have understood all information about the project and must have signed the informed consent letter about participation in the study including rehabilitation and follow-up
- The patients must have a history and clinical findings typical for primary frozen shoulder with globally reduced range of motion in the shoulder.
- The patients must not be in phase 1 (inflammation phase)
- Diabetics may be included
- MRI must be taken to exclude other reasons for stiffness
Key exclusion criteria (4 listed)
- Other reasons for stiffness( cuff rupture, arthritis)
- Posttraumatic or postoperative stiffness
- Patients not suited for day surgery
- Patients with a history of subacromial impingement before developing stiffness
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 |
|---|---|---|
| Arthroscopic capsular releaseSurgical division of thickened capsule in the shoulder | Procedure or surgery | Arthroscopic Capsulotomy |
| Distention with steroidIntraarticular distention with steroid, saline, contrast and local anaesthetic | Procedure or surgery | Distention with steroid |
Primary outcome
Shoulder Function
Time frame: 2 years
1 secondary outcome
Shoulder range of motion
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2009.
- BackgroundCodman EA. The Shoulder: Rupture of the Supraspinatus Tendon and Other Lesions In or About the Subacromial Bursa. Boston: Thomas Todd Co; 1934.
- Background: PubMed 5008469Bridgman JF. Periarthritis of the shoulder and diabetes mellitus. Ann Rheum Dis. 1972 Jan;31(1):69-71. doi: 10.1136/ard.31.1.69. No abstract available.
- Background: PubMed 2436441Moren-Hybbinette I, Moritz U, Schersten B. The clinical picture of the painful diabetic shoulder--natural history, social consequences and analysis of concomitant hand syndrome. Acta Med Scand. 1987;221(1):73-82. doi: 10.1111/j.0954-6820.1987.tb01247.x.
- Results publication: PubMed 670287Grey RG. The natural history of "idiopathic" frozen shoulder. J Bone Joint Surg Am. 1978 Jun;60(4):564. No abstract available.
- Results publication: PubMed 1198072Reeves B. The natural history of the frozen shoulder syndrome. Scand J Rheumatol. 1975;4(4):193-6. doi: 10.3109/03009747509165255.
- Results publication: PubMed 6742896Binder AI, Bulgen DY, Hazleman BL, Roberts S. Frozen shoulder: a long-term prospective study. Ann Rheum Dis. 1984 Jun;43(3):361-4. doi: 10.1136/ard.43.3.361.
- Results publicationDuplay ES. De la periarthrite scapulo-humérale et des raideurs de l'épaule qui en sont la conséquence. Arch Gen Med 1872;20:513-42.
- Results publication: PubMed 16356983Dias R, Cutts S, Massoud S. Frozen shoulder. BMJ. 2005 Dec 17;331(7530):1453-6. doi: 10.1136/bmj.331.7530.1453.
- Results publication: PubMed 1624489Shaffer B, Tibone JE, Kerlan RK. Frozen shoulder. A long-term follow-up. J Bone Joint Surg Am. 1992 Jun;74(5):738-46.
- Results publication: PubMed 3708230Pal B, Anderson J, Dick WC, Griffiths ID. Limitation of joint mobility and shoulder capsulitis in insulin- and non-insulin-dependent diabetes mellitus. Br J Rheumatol. 1986 May;25(2):147-51. doi: 10.1093/rheumatology/25.2.147.
- Results publication: PubMed 7559688Bunker TD, Anthony PP. The pathology of frozen shoulder. A Dupuytren-like disease. J Bone Joint Surg Br. 1995 Sep;77(5):677-83.
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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.
Jannike Øyen, M Sc contact
Eirik J Solheim, MD, PhD study chair
University of Bergen, Surgical Dept.
Leiv Hove, MD, PhD study director
University of Bergen, Surgical Dept.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthroscopic capsular release and Distention with steroid in people with Adhesive Capsulitis, run by Bergen Surgical 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 7 inclusion and 4 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 16 Dec 2009. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ove K Austgulen, MD (+4793232026, ovaust@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Function (time frame: 2 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 NCT01029600, which also lists 11 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 16 Dec 2009.