Shoulder CapsulitisPhase 3FSSNCT01570985
Treatment Study of Frozen Shoulder: Corticosteroid Injection in Joint Versus Wait and See Policy
A Phase 3 study testing Triamcinolone Acetonide in people with Shoulder Capsulitis and Shoulder Adhesive Capsulitis, run by Satya Pal Sharma at 1 site in Norway.
Trial summary
This is a study on the treatment of frozen shoulder with injection of cortisone into the shoulder joint. The purpose of the study is to evaluate whether injection with stretching of the shoulder capsule or plain injection is more effective than no specific treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Capsulitis, Shoulder Adhesive Capsulitis, Frozen Shoulder
- What is being tested?
- Triamcinolone Acetonide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2010to Dec 2015
- Phase
- Phase 3
- 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
- Patients who on clinical examination show reduced shoulder movements with pain where commonly lateral rotation is most restricted, medial rotation least restricted and abduction is somewhat restricted, somewhere in between the two other movements, is called a capsular pattern of movement confirming shoulder capsulitis
- Had had the condition for at least 2 months
- Reduction of movement is at least 30% of normal in two of the three passive movements
- Are ready to undergo treatment as set up before hand (agree to participate in one of the three groups)
- Agree not to undergo other treatment simultaneously directed at the stiff shoulder other than in the control group
- Patient has voluntarily given his/her written consent for participation
- Has not already received intraarticular corticosteroid injection prior to entry in the study less than 4 weeks earlier
Who cannot join
- Diabetes, as in some diabetic patients, steroids can disturb the regulation of their blood sugar levels.
- One of the two shoulder movements are normal, either passive abduction or passive lateral rotation
- Have some systemic disease where use of corticosteroids is either contraindicated or affect the coexisting disorder
- Patients with asthma using steroid inhalations or steroids orally
- There are other coexisting disorders in the arm or patient has a painful neck that can disturb pain and functional assessment of the shoulder
- Pregnant and breast feeding mothers
Show all 9Show fewer
- Patients under 18 years of age
- Patients who do not understand Norwegian
- Patients who have reduced intellectual capacity for consent-giving
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outcome in Shoulder Capsulitis (Frozen Shoulder) Between Corticosteroid and Corticosteroid With Distension Compared to Wait and See Policy, a Randomised Controlled Trial
This is a study on the treatment of frozen shoulder with injection of cortisone into the shoulder joint. The purpose of the study is to evaluate whether injection with stretching of the shoulder capsule or plain injection is more effective than no specific treatment.
Read the detailed description
Shoulder capsulitis or frozen shoulder is a painful condition causing limitations of shoulder movements. Its incidence is about 2%, comprising mostly women. There is a need for more controlled trials on frozen shoulder preferably in general practice, without using technical guiding instruments for injections as MRI or computer tomography, because the condition is routinely treated in general practice. It was therefore important to conduct this study as similar as possible to current practice. The procedure should be simple, safe and less time consuming.
Patients will be allocated to the study groups by computerized block-randomization with three permutations per block. Group 1 consists of patients receiving Triamcinolone 20 mg intraarticular injection with Lidocaine 10mg/ml 3 ml and a total of 4 ml solution. Group 2 patients will receive intraarticular Triamcinolone 20 mg, 3 ml Lidocaine and the rest with physiological natrium chloride 9 mg/ml, comprising a total volume from 8 ml and upwards up to 20 ml. Group 3 will serve as a control group and patients in this group could receive any other treatment other than corticosteroid injections or per oral corticosteroid medication. The control group will remain without treatment with corticosteroids, in injection or tablet form till 61 days, which is also the last day of the outcome measurements. The time interval between the 1st and 2nd treatment will be 7 days, between the 2nd and 3rd treatment 10 days, and between the 3rd and 4th treatment 14 days. Patients will also receive a follow-up by mail 6 and 12 months after the inclusion, where pain and function (SPADI) is investigated.
The patients will be explained and instructed in filling out schema for SPADI, NPRS, pain figure, for sleep Bergen Insomnia Scale (BIS), EPQ-N to measure neuroticism, and Subjective Health Complaints (SHC).
- Being tested
- Triamcinolone Acetonide
- Keywords
- shoulder capsulitis, frozen shoulder, adhesive capsulitis, distension, corticosteroid injection, intraarticular injection
- Medical subject headings
- Bursitis, Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone AcetonideDrug
Also called Kenacort-T H02A B08
Triamcinolone 20 mg intraarticular injection with Lidocaine 10mg/ml 3 ml and variable amount of saline of 4 ml solution on day 1, day 7, day 17 and day 31st.
Triamcinolone AcetonideDrug
Also called Kenacort-T H02A B08
Patients in group 2 will receive intraarticular Triamcinolone 20 mg, 3 ml Lidocaine and physiological natrium chloride 9 mg/ml, comprising a total volume from 8 ml and upwards up to 20 ml
| Study group | Role | What they receive |
|---|---|---|
| Steroid injection Without distension | Active comparator | Group 1 consists of patients receiving Triamcinolone acetonide 20 mg intraarticular injection with Lidocaine 10mg/ml 3 ml and a total of 4 ml solution. Receives: Drug: Triamcinolone Acetonide |
| Steroid with distension | Active comparator | Patients in group 2 will receive intraarticular Triamcinolone Acetonide 20 mg, 3 ml Lidocaine and physiological natrium chloride 9 mg/ml, comprising a total volume from 8 ml and upwards up to 20 ml Receives: Drug: Triamcinolone Acetonide |
| Control | No intervention | Group 3 will serve as control group and patients in this group could receive any other treatment other than corticosteroid injections or per oral corticosteroid medication. The control group will remain without treatment with corticosteroids, in injection or tablet form till 61 days, which is also the last day of the outcome measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder pain and disability index (SPADI)
The primary outcome measure is Shoulder Pain and Disability Index (SPADI). According to a previous study, the SPADI score of ≥10 indicate clinically important improvement (or worsening) of shoulder function (Williams et al. 1995). A total of 3 measurements will be taken for all participants: baseline measurement on day 1, 2nd measurement on the 31st day and last measurement the 61st day. All end point effect measurements (primary, secondary \& tertiary) are targeted at 61 days.In addition pain and function (SPADI) will be evaluated at 6 months and 12 months.
Measured: 8 weeks
Secondary outcomes (1)
A 10-point Numerical Pain Rating Scale (NPRS)
A total of 3 measurements will be taken for all participants: baseline measurement on day 1, 2nd measurement on the 31st day and last measurement the 61st day. All end point effect measurements (primary, secondary \& tertiary) are targeted at 61 days.
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 posted4 Apr 2012 (estimated)
- Study startFeb 2010
- Primary completionDec 2013
- Study completionDec 2015 (estimated)
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 Shoulder 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Satya Pal Sharma
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Medical Association
- Responsible party
- Sponsor-investigator, Satya Pal Sharma, University of Bergen
- Investigators
- Anders Barheim, MD PhD, Study chair, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570985
- Sponsor's protocol ID
- FSS-2010-SKB
- Other IDs
- 2008-004385-49, 2008
- Acronym
- FSS
- Status last verified
- May 2015
- First submitted
- 27 Mar 2012
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sharma SP, Moe-Nilssen R, Kvale A, Baerheim A. Predicting outcome in frozen shoulder (shoulder capsulitis) in presence of comorbidity as measured with subjective health complaints and neuroticism. BMC Musculoskelet Disord. 2017 Sep 2;18(1):380. doi: 10.1186/s12891-017-1740-9.
PubMed 28865441Sharma SP, Baerheim A, Moe-Nilssen R, Kvale A. Adhesive capsulitis of the shoulder, treatment with corticosteroid, corticosteroid with distension or treatment-as-usual; a randomised controlled trial in primary care. BMC Musculoskelet Disord. 2016 May 26;17:232. doi: 10.1186/s12891-016-1081-0.
PubMed 27229470
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome in Shoulder Capsulitis (Frozen Shoulder) Between Corticosteroid and Corticosteroid With Distension Compared to Wait and See Policy, a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01570985
- Acronym / sponsor ID
- FSS / FSS-2010-SKB
- Keywords
- shoulder capsulitis, frozen shoulder, adhesive capsulitis, distension, corticosteroid injection, intraarticular injection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Satya Pal SharmaUniversity, hospital or other
- Collaborators
- Norwegian Medical Association
- Study start
- Feb 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2015 (estimated)
- First posted
- 4 Apr 2012 (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.
This is a study on the treatment of frozen shoulder with injection of cortisone into the shoulder joint. The purpose of the study is to evaluate whether injection with stretching of the shoulder capsule or plain injection is more effective than no specific treatment.
Detailed description
Shoulder capsulitis or frozen shoulder is a painful condition causing limitations of shoulder movements. Its incidence is about 2%, comprising mostly women. There is a need for more controlled trials on frozen shoulder preferably in general practice, without using technical guiding instruments for injections as MRI or computer tomography, because the condition is routinely treated in general practice. It was therefore important to conduct this study as similar as possible to current practice. The procedure should be simple, safe and less time consuming.
Patients will be allocated to the study groups by computerized block-randomization with three permutations per block. Group 1 consists of patients receiving Triamcinolone 20 mg intraarticular injection with Lidocaine 10mg/ml 3 ml and a total of 4 ml solution. Group 2 patients will receive intraarticular Triamcinolone 20 mg, 3 ml Lidocaine and the rest with physiological natrium chloride 9 mg/ml, comprising a total volume from 8 ml and upwards up to 20 ml. Group 3 will serve as a control group and patients in this group could receive any other treatment other than corticosteroid injections or per oral corticosteroid medication. The control group will remain without treatment with corticosteroids, in injection or tablet form till 61 days, which is also the last day of the outcome measurements. The time interval between the 1st and 2nd treatment will be 7 days, between the 2nd and 3rd treatment 10 days, and between the 3rd and 4th treatment 14 days. Patients will also receive a follow-up by mail 6 and 12 months after the inclusion, where pain and function (SPADI) is investigated.
The patients will be explained and instructed in filling out schema for SPADI, NPRS, pain figure, for sleep Bergen Insomnia Scale (BIS), EPQ-N to measure neuroticism, and Subjective Health Complaints (SHC).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Steroid injection Without distension | Active comparator | Drug: Triamcinolone AcetonideGroup 1 consists of patients receiving Triamcinolone acetonide 20 mg intraarticular injection with Lidocaine 10mg/ml 3 ml and a total of 4 ml solution. |
| Steroid with distension | Active comparator | Drug: Triamcinolone AcetonidePatients in group 2 will receive intraarticular Triamcinolone Acetonide 20 mg, 3 ml Lidocaine and physiological natrium chloride 9 mg/ml, comprising a total volume from 8 ml and upwards up to 20 ml |
| Control | No intervention | –Group 3 will serve as control group and patients in this group could receive any other treatment other than corticosteroid injections or per oral corticosteroid medication. The control group will remain without treatment with corticosteroids, in injection or tablet form till 61 days, which is also the last day of the outcome measurements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who on clinical examination show reduced shoulder movements with pain where commonly lateral rotation is most restricted, medial rotation least restricted and abduction is somewhat restricted, somewhere in between the two other movements, is called a capsular pattern of movement confirming shoulder capsulitis
- Had had the condition for at least 2 months
- Reduction of movement is at least 30% of normal in two of the three passive movements
- Are ready to undergo treatment as set up before hand (agree to participate in one of the three groups)
- Agree not to undergo other treatment simultaneously directed at the stiff shoulder other than in the control group
Key exclusion criteria (9 listed)
- Diabetes, as in some diabetic patients, steroids can disturb the regulation of their blood sugar levels.
- One of the two shoulder movements are normal, either passive abduction or passive lateral rotation
- Have some systemic disease where use of corticosteroids is either contraindicated or affect the coexisting disorder
- Patients with asthma using steroid inhalations or steroids orally
- There are other coexisting disorders in the arm or patient has a painful neck that can disturb pain and functional assessment of the shoulder
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 AcetonideAlso: Kenacort-T H02A B08Triamcinolone 20 mg intraarticular injection with Lidocaine 10mg/ml 3 ml and variable amount of saline of 4 ml solution on day 1, day 7, day 17 and day 31st. | Drug | Steroid injection Without distension |
| Triamcinolone AcetonideAlso: Kenacort-T H02A B08Patients in group 2 will receive intraarticular Triamcinolone 20 mg, 3 ml Lidocaine and physiological natrium chloride 9 mg/ml, comprising a total volume from 8 ml and upwards up to 20 ml | Drug | Steroid with distension |
Primary outcome
Shoulder pain and disability index (SPADI)
Time frame: 8 weeks
The primary outcome measure is Shoulder Pain and Disability Index (SPADI). According to a previous study, the SPADI score of ≥10 indicate clinically important improvement (or worsening) of shoulder function (Williams et al. 1995). A total of 3 measurements will be taken for all participants: baseline measurement on day 1, 2nd measurement on the 31st day and last measurement the 61st day. All end point effect measurements (primary, secondary \& tertiary) are targeted at 61 days.In addition pain and function (SPADI) will be evaluated at 6 months and 12 months.
1 secondary outcome
A 10-point Numerical Pain Rating Scale (NPRS)
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
- Derived from this study: PubMed 28865441Sharma SP, Moe-Nilssen R, Kvale A, Baerheim A. Predicting outcome in frozen shoulder (shoulder capsulitis) in presence of comorbidity as measured with subjective health complaints and neuroticism. BMC Musculoskelet Disord. 2017 Sep 2;18(1):380. doi: 10.1186/s12891-017-1740-9.
- Derived from this study: PubMed 27229470Sharma SP, Baerheim A, Moe-Nilssen R, Kvale A. Adhesive capsulitis of the shoulder, treatment with corticosteroid, corticosteroid with distension or treatment-as-usual; a randomised controlled trial in primary care. BMC Musculoskelet Disord. 2016 May 26;17:232. doi: 10.1186/s12891-016-1081-0.
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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.
Anders Barheim, MD PhD study chair
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Triamcinolone Acetonide in people with Shoulder Capsulitis and Shoulder Adhesive Capsulitis, run by Satya Pal Sharma 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 9 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 28 May 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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: 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 NCT01570985, 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 28 May 2015.