Groningen Hand and Wrist Injection Therapy Trial (HAWITT)

ISRCTN	ISRCTN53171398
DOI	https://doi.org/10.1186/ISRCTN53171398
Protocol serial number	NTR326
Sponsor	University Medical Centre Groningen (UMCG) (Netherlands)
Funders	Bristol-Myers Squibb (Netherlands), Fund for Common Disorders from the Netherlands College of General Practitioners (Fonds Alledaagse Ziekten van het Nederlands Huisartsen Genootschap) (Netherlands), University Medical Centre Groningen (UMCG) (Netherlands) - Department of General Practice

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 05/11/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms C. Peters-Veluthamaningal
Scientific

University Medical Center Groningen
University of Groningen Department of General Practice
Antonius Deusinglaan 1
Groningen
9713 AV
Netherlands

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

Study information

Primary study design	Interventional
Study design	Randomised, double blinded, placebo controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	Efficacy and safety of corticosteroid injections for trigger finger, de Quervains tenosynovitis and carpal tunnel syndrome in primary care: a randomised, controlled trial
Study acronym	HAWITT
Study objectives	Local injection therapy with 1 ml of triamcinolonacetonide (10 mg/ml) provided by a primary care physician is more effective than injection with 1 ml NaCl (0,9%) for trigger finger, de Quervain's tenosynovitis and carpal tunnel syndrome.
Ethics approval(s)	Ethics approval received from local medical ethics committee
Health condition(s) or problem(s) studied	Tenosynovitis, carpal tunnel syndrome
Intervention	One to two local injections of 1 ml of triamcinolonacetonide (10 mg/ml) versus 1 ml of NaCl 0.9% (placebo) one week after inclusion.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Triamcinolonacetonide
Primary outcome measure(s)	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: 4.1. TF/MdeQ: Arthritis Impact Measurement Scale 2 (AIMS 2), sub items hand-and finger function 4.2. 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.
Key secondary outcome measure(s)	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) 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.
Completion date	01/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex
Target sample size at registration	120
Key inclusion criteria	Patients in primary care presenting with a clinical diagnosis of trigger finger, de Quervain's tenosynovitis or carpal tunnel syndrome.
Key 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
Date of first enrolment	01/12/2002
Date of final enrolment	01/12/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

University Medical Center Groningen

Groningen
9713 AV
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/09/2008	Yes	No
Results article	results	27/10/2009	Yes	No
Results article	results	29/07/2010	Yes	No