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Groningen Hand and Wrist Injection Therapy Trial (HAWITT).

Efficacy and safety of corticosteroid injections for trigger finger, de Quervains tenosynovitis and carpal tunnel syndrome in primary care: a randomized, controlled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22395
Enrollment
120
Registered
2005-09-18
Start date
2002-12-01
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

tenosynovitis, trigger finger, trigger digit, carpal tunnel syndrome

Interventions

1-2 local injections of 1 ml of triamcinolonacetonide (10mg/ml) versus 1 ml of NaCl 0,9% (placebo) one week after inclusion.

Sponsors

Department of General Practice University Medical Center University of Groningen
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients in primary care presenting with a clinical diagnosis of trigger finger, de Quervain's tenosynovitis or carpal tunnel syndrome.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
1. 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

MeasureTime frame
1. 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.

Contacts

Public ContactC. Peters-Veluthamaningal

University Medical Center Groningen (UMCG), Department of General Practice, Antonius Deusinglaan 1

r.peters@home.nl+31 (0)50 3632963

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)