Condition category
Musculoskeletal Diseases
Date applied
04/10/2007
Date assigned
10/10/2007
Last edited
02/10/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.forskningsradet.no

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18423042

Publication citations

  1. 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.

Additional files

Editorial Notes