Contact information
Type
Scientific
Primary contact
Dr Einar Kristian Tveita
ORCID ID
Contact details
Elgfaret 8
Hornnes
4737
Norway
e.k.tveita@medisin.uio.no
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NFR10458
Study information
Scientific title
Acronym
Study hypothesis
The null hypothesis of the study is that corticosteroid injection with or without hydrodilatation are equally effective as treatment of shoulder capsulitis.
Ethics approval
Regional Norwegian Ethics Committee in November 2003.
Study design
Single-centre, interventional, open, randomised study comparing the treatment effect of two different treatment regimens.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Adhesive capsulitis of the shoulder
Intervention
Corticosteroid injection with or without a hydrodilatation procedure. Both treatment groups are given the following drugs in each injection:
1. 3 - 4 ml lopromide, Ultravist 300 Schering AG
2. 2 ml triamcinolone acetonide, Kenacort 10 mg/ml Bristol-Myers Squibb
3. 3 - 4 ml bupivacaine hydrochloride, Marcain 5 mg/ml Astra Zeneca
Both groups are given this injection into the glenohumeral joint under fluoroscopic guidance. The difference between the groups is that the hydrodilatation group is given an additional volume of 10 - 20 ml of Ultravist/Marcain under pressure, in order to distend the glenohumeral joint capsule, which is contracted in these patients.
Three injections are given with two-week intervals. This means that the total duration of treatment is 4 weeks, follow-up is at six weeks after the last injection, 10 weeks in total. Adhesive capsulitis is a temporary condition.
Intervention type
Drug
Phase
Not Specified
Drug names
Corticosteroid
Primary outcome measure
Improvement in Shoulder Pain and Disability Index, measured 6 weeks after the last of three injections.
Secondary outcome measures
Shoulder range of motion for four different directions of passive and active movements are measured at baseline and then again six weeks after the last of the three injections. The score at follow-up is the outcome measure.
Overall trial start date
01/12/2003
Overall trial end date
01/02/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Pain in one shoulder for more than 3 months but less than 2 years
2. Reduction in shoulder range of motion
3. Ability to fill out shoulder self-report form
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
88
Participant exclusion criteria
1. Age below 18 or over 70
2. Various contraindications to injection material
3. Restriction in range of motion for reasons other than capsulitis
4. Mental illness
5. Cancer
6. Current medication with corticosteroids
Recruitment start date
01/12/2003
Recruitment end date
01/02/2008
Locations
Countries of recruitment
Norway
Trial participating centre
Elgfaret 8
Hornnes
4737
Norway
Sponsor information
Organisation
Norwegian Research Council (Norway)
Sponsor details
Norges Forskningsrad
Postboks 2700
St. Hanshaugen
Oslo
0407
Norway
post@forskningsradet.no
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Norwegian Research Council (Norway) (ref: 10458)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18423042
Publication citations
-
Results
Tveitå EK, Tariq R, Sesseng S, Juel NG, Bautz-Holter E, Hydrodilatation, corticosteroids and adhesive capsulitis: a randomized controlled trial., BMC Musculoskelet Disord, 2008, 9, 53, doi: 10.1186/1471-2474-9-53.