Transmural project for subacromial impingement syndrome: a randomized controlled trial comparing a new transmural treatment strategy (TRANSIT) with usual medical care

ISRCTN	ISRCTN58108023
DOI	https://doi.org/10.1186/ISRCTN58108023
Protocol serial number	NL542 (NTR586)
Sponsor	University Medical Center Groningen (UMCG), Department Orthopaedic Surgery (The Netherlands)
Funder	University Medical Center Groningen (UMCG), Health Care Efficiency fund

Submission date: 04/04/2006
Registration date: 04/04/2006
Last edited: 20/08/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr O. Dorrestijn
Scientific

University Medical Center Groningen
Department Orthopaedic Surgery
P.O. Box 30.001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 3610078
Email	transitonderzoek@gmail.com

Study information

Primary study design	Interventional
Study design	Randomized controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Transmural project for subacromial impingement syndrome: a randomized controlled trial comparing a new transmural treatment strategy (TRANSIT) with usual medical care
Study acronym	TRANSIT
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/11/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	70
Key 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
Key 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
Date of first enrolment	08/03/2006
Date of final enrolment	01/11/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Groningen

Groningen
9700 RB
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Study protocol:	22/02/2007		Yes	No

Editorial Notes

20/08/2021: Proactive update review. No publications found. Search options exhausted.