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
Scientific
Elgfaret 8
Hornnes
4737
Norway
| e.k.tveita@medisin.uio.no |
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | The 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/12/2003 |
| Completion date | 01/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 88 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/12/2003 |
| Date of final enrolment | 01/02/2008 |
Locations
Countries of recruitment
- Norway
Study participating centre
Elgfaret 8
Hornnes
4737
Norway
4737
Norway
Sponsor information
Norwegian Research Council (Norway)
Research council
Research council
Norges Forskningsrad
Postboks 2700
St. Hanshaugen
Oslo
0407
Norway
| post@forskningsradet.no | |
| Website | http://www.forskningsradet.no |
"ROR" |
https://ror.org/00epmv149 |
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
