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van CCT (UK)

van CCT (UK)

Groningen Hand and Wrist Injection Therapy Trial (HAWITT).

- candidate number1701
- NTR NumberNTR326
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR18-sep-2005
- Secondary IDsN/A 
- Public TitleGroningen Hand and Wrist Injection Therapy Trial (HAWITT).
- Scientific TitleEfficacy and safety of corticosteroid injections for trigger finger, de Quervains tenosynovitis and carpal tunnel syndrome in primary care: a randomized, controlled trial.
- hypothesisLocal 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.
- Healt Condition(s) or Problem(s) studiedTenosynovitis, Trigger finger, Trigger digit, Carpal tunnel syndrome
- Inclusion criteriaPatients in primary care presenting with a clinical diagnosis of trigger finger, de Quervain's tenosynovitis or carpal tunnel syndrome.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2002
- planned closingdate1-dec-2006
- Target number of participants120
- Interventions1-2 local injections of 1 ml of triamcinolonacetonide (10mg/ml) versus 1 ml of NaCl 0,9% (placebo) one week after inclusion.
- Primary outcome1. Patients perceived recovery (7-points numeric rating scale: from much worse to much better as compared to pre-treatment);
2. Severity of pain/ main complaint (11 point numeric rating scale: 0-10, CTS: severity of symptoms according to the Boston Carpal tunnel questionnaire);
3. TF: triggering and/or clicking and/or locking (4 point ordinal scale: 0= never, 1=incidental, 2=weekly, 3=daily, 4=always);
4. Functional impairment:
a. TF/ MdeQ: Arthitis Impact Measurement Scale 2 (AIMS 2), subitems hand-and finger function;
b. CTS: functional impairment according to the Boston Carpal tunnel questionnaire;
Timing of measurements: 1 week after last injection and follow-up 1,3,6 and 12 months after intervention.
- Secondary outcome1. Occurrence of short and longterm side-effects and serious adverse events: questions regarding the occurrence of steroid-flare, flushes, menstrual abnormalities,hyperglycemia in diabetic patients and questions regarding presence/absence of clinical signs suggesting fat-atrophy, tendon-rupture and median-neuritis (in CTS);
2. Recurrences (when and how many), management of recurrences;
3. Patient satisfaction with injection-therapy (follow-up at 1 month, 7-point numeric scale: 0=very dissatisfied, 6=very satisfied);
4. Treatment-preferences after undergoing treatment (no treatment, physical therapy, wrist-splinting, injection therapy with steroid, operation);
Timing of measurements: 1 week after last injection and follow-up 1,3,6 and 12 months after intervention.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES C. Peters-Veluthamaningal
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of General Practice
- Funding
(Source(s) of Monetary or Material Support)
Fonds Alledaagse Ziekten van het Nederlands Huisartsen Genootschap, University Medical Center Groningen (UMCG), Department of General Practice, Bristol-Myers, Squibb
- PublicationsN/A
- Brief summaryLocal 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).
- Main changes (audit trail)
- RECORD18-sep-2005 - 14-sep-2009

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