Hydrodilatation, corticosteroids and adhesive capsulitis: a randomised controlled trial

ISRCTN ISRCTN90567697
DOI https://doi.org/10.1186/ISRCTN90567697
Secondary identifying numbers NFR10458
Submission date
04/10/2007
Registration date
10/10/2007
Last edited
02/10/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Einar Kristian Tveita
Scientific

Elgfaret 8
Hornnes
4737
Norway

e.k.tveita@medisin.uio.no

Study information

Study designSingle-centre, interventional, open, randomised study comparing the treatment effect of two different treatment regimens.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesThe null hypothesis of the study is that corticosteroid injection with or without hydrodilatation are equally effective as treatment of shoulder capsulitis.
Ethics approval(s)Regional Norwegian Ethics Committee in November 2003.
Health condition(s) or problem(s) studiedAdhesive capsulitis of the shoulder
InterventionCorticosteroid 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Corticosteroid
Primary outcome measureImprovement in Shoulder Pain and Disability Index, measured 6 weeks after the last of three injections.
Secondary outcome measuresShoulder 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 study start date01/12/2003
Completion date01/02/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target number of participants88
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment01/12/2003
Date of final enrolment01/02/2008

Locations

Countries of recruitment

  • Norway

Study participating centre

Elgfaret 8
Hornnes
4737
Norway

Sponsor information

Funders

Funder type

Research council

Norwegian Research Council (Norway) (ref: 10458)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 19/04/2008 Yes No
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