Local injection therapy with 1ml of triamcinolonacetonide (10mg/ml) provided by a primary care physician is more effective than injection with 1ml NaCl (0,9%) for trigger finger, de Quervain's tenosynovitis and carpal tunnel syndrome.
ID
Bron
Verkorte titel
Aandoening
tenosynovitis, trigger finger, trigger digit, carpal tunnel syndrome
Ondersteuning
University Medical Center
University of Groningen
-department of general practice, University Medical Center, University of Groningen
-unrestricted educational grant from pharmaceutical company Bristol-Myers, Squibb
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
1. Patients perceived recovery (7-points numeric rating scale: from much worse to much better as compared to pre-treatment);<br>
2. Severity of pain/ main complaint (11 point numeric rating scale: 0-10, CTS: severity of symptoms according to the Boston Carpal tunnel questionnaire);<br>
3. TF: triggering and/or clicking and/or locking (4 point ordinal scale: 0= never, 1=incidental, 2=weekly, 3=daily, 4=always);<br>
4. Functional impairment:<br>
a. TF/ MdeQ: Arthitis Impact Measurement Scale 2 (AIMS 2), subitems hand-and finger function;<br>
b. CTS: functional impairment according to the Boston Carpal tunnel questionnaire;<br>
Timing of measurements: 1 week after last injection and follow-up 1,3,6 and 12 months after intervention.
Achtergrond van het onderzoek
Local injectiontherapy with corticosteroids is an accepted (initial) treatment modality for carpal tunnel syndrome (CTS), trigger finger (TF) and de Quervain's tenosynovitis (MdeQ), with reported longterm (1 year) efficacy of 50-90% (MdeQ and TF) and 50% (CTS). However, all available data originate from specialist clinical centres, no studies concerning effectiveness of this therapy have been performed so far in general practice.
The HAWITT intervention-study assesses the effectiveness, safety and feasibility of injectiontherapy with triamcinolon-acetonide (1ml=10mg) as compared to placebo-treatment (1ml NaCl 0,9%). Patients will be injected (double-blind) up to two times, after randomization, with either steroids or placebo. One week after each injection clinical findings used as outcome-measurements will be assessed by the treating general practitioner. Follow-up at 1, 3, 6, and 12 months post-treatment will consist of written questionnaires sent to the patient.
Thirty general practices in the northern part of the Netherlands will participate in the HAWITT-trial. A total of 120 patients will be included in the intervention-study (70 CTS, 50 TF/MdeQ). Patients will be followed up for one year; the total duration of the study will be three years (end of trial: December 2006).
Doel van het onderzoek
Local injection therapy with 1ml of triamcinolonacetonide (10mg/ml) provided by a primary care physician is more effective than injection with 1ml NaCl (0,9%) for trigger finger, de Quervain's tenosynovitis and carpal tunnel syndrome.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
1-2 local injections of 1 ml of triamcinolonacetonide (10mg/ml) versus 1 ml of NaCl 0,9% (placebo) one week after inclusion.
Algemeen / deelnemers
Antonius Deusinglaan 1
C. Peters-Veluthamaningal
Antonius Deusinglaan 1
Groningen 9713 AV
The Netherlands
+31 (0)50 3632963
r.peters@home.nl
Wetenschappers
Antonius Deusinglaan 1
C. Peters-Veluthamaningal
Antonius Deusinglaan 1
Groningen 9713 AV
The Netherlands
+31 (0)50 3632963
r.peters@home.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients in primary care presenting with a clinical diagnosis of trigger finger, de Quervain's tenosynovitis or carpal tunnel syndrome.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Minor age;
2. Absolute contra-indication for steroid injection;
3. Prior treatment with steroid injection in the last 6 months or surgical treatment (ever) for same condition at same anatomical site;
4. Traumatic or neoplastic origin of condition;
5. Participant not able to fill in questionnaires;
6. Absence of self-determination;
7. No consent;
8. In carpal tunnel syndrome: thenar atrophy and/or weakness.
Opzet
Deelname
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Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
Register | ID |
---|---|
NTR-new | NL288 |
NTR-old | NTR326 |
Ander register | : N/A |
ISRCTN | ISRCTN53171398 |