Condition category
Musculoskeletal Diseases
Date applied
04/04/2006
Date assigned
04/04/2006
Last edited
01/03/2007
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

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

Sponsor information

Organisation

University Medical Center Groningen (UMCG), Department Orthopaedic Surgery (The Netherlands)

Sponsor details

P.O. Box 30.001
Groningen
9700 RB
Netherlands

Sponsor type

Not defined

Website

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

  1. 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.

Additional files

Editorial Notes