Contact information
Type
Scientific
Primary contact
Mr O. Dorrestijn
ORCID ID
Contact details
University Medical Center Groningen
Department Orthopaedic Surgery
P.O. Box 30.001
Groningen
9700 RB
Netherlands
+31 (0)50 3610078
transitonderzoek@gmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
TRANSIT
Study hypothesis
TRANSIT will give patients who have a subacromial impingement syndrome a reduced recovery time, more improvement of arm function and more reduction of shoulder pain compared to patients treated with usual medical care.
Ethics approval
Not provided at time of registration
Study design
Randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Subacromial impingement syndrome
Intervention
Intervention group: the treatment is an arthroscopic subacromial decompression performed within six weeks after randomization.
Control group: the treatment is usual medical care, which consists of treatment in general practice according to the Guidelines for Shoulder Complaints of the Dutch College of General Practitioners (issued in 1999).
Both groups will be followed for one year post-randomization.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Shoulder Disability Questionnaire: a 16-item measure for functional status limitation in patients with shoulder disorders (Van der Heijden et al, 2000).
Study data will be collected at the following moments: at inclusion, at randomization and three, six and twelve months after randomization.
Secondary outcome measures
1. Constant-Murley score - a shoulder-specific scoring system in which patient-reported subjective assessment and objective measurement of shoulder function takes place (Constant et al, 1987)
2. Shoulder Pain Score - a concise questionnaire for the assessment of pain experienced by patients with shoulder complaints (Winters et al, 1996)
3. Shoulder Rating Questionnaire (SRQ-DLV) - a self-administered patient based instrument which assesses shoulder function in seven domains (Vermeulen et al, 2005)
4. Patient-perceived recovery - a one-item score concerning recovery following treatment measured on a seven-point ordinal scale
5. (Dutch) Short-form 36 Health Survey - a Health-related Quality of Life Assessment system composed of 36 questions and standardized response choices, organized into eight multi-item scales (Aaronson, 1998).
6. Cost-effectiveness - an economic evaluation will be performed using a questionnaire for assessment of direct health care costs as well as direct non-health related costs. These data will be used for a cost-effectiveness analysis.
Overall trial start date
08/03/2006
Overall trial end date
01/11/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Pain on abduction of the shoulder
2. Shoulder pain as a recurrence of an episode with a maximum duration of 12 months in which a partial or good response is achieved with (a) subacromial corticosteroid injection(s)
3. A maximum duration of three months of shoulder complaints prior to the first subacromial injection, possibly treated with non-steroidal anti-inflammatory drug (NSAID) and/or physiotherapy
4. No shoulder complaints for at least two years prior to the current episode of shoulder pain
5. Men and women, aged between 30 and 60 years
6. Being able to give an informed consent
Amendment to inclusion criterion number 3 as of 24/07/2006:
3. A maximum duration of six months of shoulder complaints prior to the first subacromial injection, possibly treated with non-steroidal anti-inflammatory drug (NSAID) and/or physiotherapy
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
70
Participant exclusion criteria
1. Shoulder girdle pain
2. Shoulder pain not based on pain on abduction of the shoulder
3. Signs of cervical root compression
4. Bilateral shoulder pain
5. Secondary subacromial impingement
6. Presence of specific rheumatic diseases
7. History of severe trauma of the shoulder (fracture or luxation)
8. Previous surgery of the affected shoulder
9. Extrinsic causes of shoulder pain
10. Presence of dementia of other psychiatric disorders
11. Not being able to fill in questionnaires in Dutch
Recruitment start date
08/03/2006
Recruitment end date
01/11/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen
Groningen
9700 RB
Netherlands
Funders
Funder type
University/education
Funder name
University Medical Center Groningen (UMCG), Health Care Efficiency fund
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
Study protocol: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17316441
Publication citations
-
Study protocol
Dorrestijn O, Stevens M, Diercks RL, van der Meer K, Winters JC, A new interdisciplinary treatment strategy versus usual medical care for the treatment of subacromial impingement syndrome: a randomized controlled trial., BMC Musculoskelet Disord, 2007, 8, 15, doi: 10.1186/1471-2474-8-15.