Groningen Hand and Wrist Injection Therapy Trial (HAWITT)

Completed

Conditions: Tenosynovitis, carpal tunnel syndrome
Nervous System Diseases
Mononeuropathies of upper limb

Registration Number: ISRCTN53171398

Lead Sponsor: niversity Medical Centre Groningen (UMCG) (Netherlands)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

1. Under 18 years
2. Absolute contraindication 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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>4.1. TF/MdeQ: Arthritis Impact Measurement Scale 2 (AIMS 2), sub items hand-and finger function<br>4.2. CTS: functional impairment according to the Boston Carpal tunnel questionnaire<br><br>Timing of measurements: 1 week after last injection and follow-up 1, 3, 6 and 12 months after intervention.

Secondary Outcome Measures

Name	Time	Method
1. Occurrence of short and long-term 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)<br>2. Recurrences (when and how many), management of recurrences<br>3. Patient satisfaction with injection-therapy (follow-up at 1 month, 7-point numeric scale: 0 = very dissatisfied, 6 = very satisfied)<br>4. Treatment-preferences after undergoing treatment (no treatment, physical therapy, wrist-splinting, injection therapy with steroid, operation) <br><br>Timing of measurements: 1 week after last injection and follow-up 1, 3, 6 and 12 months after intervention.