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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22906
Enrollment
70
Registered
2006-02-06
Start date
2006-03-08
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subacromial impingement syndrome.

Interventions

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

Sponsors

Department Orthopaedic Surgery University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

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 six months of shoulder complaints prior to the first subacromial injection, possibly treated with 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, age between 30 and 60 years; 6. Being able to give an informed consent.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Shoulder Disability Questionnaire: a 16-item measure for functional status limitation in patients with shoulder disorders (Van der Heijden e.a., 2000). Study data will be collected at the following moments: at inclusion, at randomization and three, six and twelve months after randomization.

Secondary

MeasureTime frame
1. Constant-Murley score; 2. Shoulder Pain Score; 3. Shoulder Rating Questionnaire; 4. Patient-perceived recovery; 5. (Dutch) Short-form 36; 6. Cost-effectiveness. The Constant-Murley Score is a shoulder-specific scoring system in which patient-reported subjective assessment and objective measurement of shoulder function takes place (Constant e.a., 1987). The Shoulder Pain Score is a concise questionnaire for the assessment of pain experienced by patients with shoulder complaints (Winters e.a., 1996). The Shoulder Rating Questionnaire (SRQ-DLV) is a self-administered patient based instrument which assesses shoulder function in seven domains (Vermeulen e.a., 2005). Patient-perceived recovery is a one-item score concerning recovery following treatment measured on a seven-point ordinal scale. The (Dutch) Short-form 36 Health Survey is a Health-related Quality of Life Assessment system and is composed of 36 questions and standardized response choices, organized into eight multi-item scales (Aaronson, 1998). 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.

Contacts

Public ContactO. Dorrestijn

University Medical Center Groningen, Department Orthopaedic Surgery, P.O. Box 30.001

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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)