WRUEP: to stop or continue?|
|- candidate number||4326|
|- NTR Number||NTR1517|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-nov-2008|
|- Secondary IDs||METC 08-3-071 |
|- Public Title||WRUEP: to stop or continue?|
|- Scientific Title||Stop-rule management in patients with sub-acute chronic pain (WRUEP): a randomized controlled and replicated single case experimental ABCD design.|
|- ACRONYM||Stop-rule management in work related upper extremity pain.|
|- Healt Condition(s) or Problem(s) studied||Repetitive Strain Injury (RSI), Non-specific work-related upper limb disorders, Repetitive Strain Injury (RSI) |
|- Inclusion criteria||1. Non-specific pain or other symptoms in neck, shoulder, elbow, arm, wrist, hand (or combination). |
2. The onset or ongoing of pain is related to work, household or other unpaid activities (for eample study or education).
3. Patients experience: . complaints (pain, local tiredness, cramping, tingling or dull feeling) during activities, but decreasing when ending the activity. · complaints (pain, tendon-/muscle irritation, aggravated feeling, insomnia and reduced strength) after work, that decrease during evenings or weekends. · ongoing complaints (pain, swelling, pressure pain, loss of functional abilities, changes in skin colour, temperature, dull or tingling feeling).
4. Patients have complaints for at least 6 weeks.
5. Patients are aged between 18-65 years old and have an adequate ability to fill in Dutch questionnaires.
|- Exclusion criteria||1. Specific complaints (biceps tendinitis, bursitis around the elbow, carpal tunnel syndrome, cervical hernia, cubital tunnel syndrome, m. Dupuytren’s syndrome, epicondylitis lateralis cubiti, epicondylitis medialis cubiti, frozen shoulder, Guyon’s canal syndrome, instability of the shoulder or elbow, labrum glenoidale ruptures, local arthritis (no RA) in an upper extremity joint, Oarsman’s wrist, radial tunnel syndrome, Raynaud’s phenomena, rotator cuff ruptures, subacromial impingement syndrome (rotator cuff syndrome, tendonitis and bursitis around the shoulder), Complex Regional Pain Syndrome-I, suprascapulair compression, triggerfinger, Quervain’s syndrome).|
2. Complaints caused by acute trauma.
3. Involvement in a law suit regarding work-disability.
4. Psychopathology, assessed with the Symptom Checklist (SCL-90). Scores on IN-SEN-HOS-PSNEUR should not be “high” or “very high” compared with the norms of the group outpatient psychiatric clients.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-nov-2008|
|- planned closingdate|
|- Target number of participants||12|
|- Interventions||Stop-rule management (SRM, experimental treatment) and regular rehabilitation (controll treatment)|
|- Primary outcome||- Functional disability (UEFS, DASH)|
- Quality of life (SF-36)
- Participation and autonomy (IPA)
|- Secondary outcome||o Demographic variables (sex, age, education, onset of pain, smoking habits, previous treatments, co-morbidity)|
o Stop-rules (HASQ)
o Pain related fear (TSK, PHODA-UE)
o Pain catastrophizing (PCS)
o Mood (PANAS)
o Responsibility (RQ)
o Physical activity in daily life (Actiwatch, PARQ)
o Pain intensity (MPQ-SF)
o Tenacious goal pursuing (TGPS)
|- Timepoints||12-2008: start inclusion and treatment (as soon as possible after METC-approval)|
4-2009: last inclusions
11-2010: last FU-assessments
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. J.R. Jong, de|
|- CONTACT for SCIENTIFIC QUERIES||Prof. Dr. Johan W.S. Vlaeyen|
|- Sponsor/Initiator ||University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|- Brief summary||Chronic musculoskeletal pain comprises an important problem in health care and society. The fear-avoidance model has been successfully tested in chronic pain patients with avoidance behaviour, but this model appears less applicable in pain disability associated with task persistence and overuse often seen in patients with non-specific Work Related Upper Extremity Pain (WREUP). The aim of the present study is to test a novel integrative model that is based on the “mood as input” paradigm, which may account for both pain responses: task escape/avoidance and task persistence, both within and between individuals. “Mood as input” theory assumes that the informational value of the mood, rather than the mood itself, determines whether participants persist at a certain task. The basic tenet is that escape/avoidance or persistence during a task is a function of the interaction between two relatively independent factors: mood and stop-rule.|
|- Main changes (audit trail)|
|- RECORD||3-nov-2008 - 9-nov-2008|
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