Condition category
Nervous System Diseases
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
05/11/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms C. Peters-Veluthamaningal

ORCID ID

Contact details

University Medical Center Groningen
University of Groningen Department of General Practice
Antonius Deusinglaan 1
Groningen
9713 AV
Netherlands
+31 (0)50 3632963
r.peters@home.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR326

Study information

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

Acronym

HAWITT

Study hypothesis

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

Ethics approval received from local medical ethics committee

Study design

Randomised, double blinded, placebo controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Triamcinolonacetonide

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/12/2002

Overall trial end date

01/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

120

Participant 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

Recruitment start date

01/12/2002

Recruitment end date

01/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Center Groningen
Groningen
9713 AV
Netherlands

Sponsor information

Organisation

University Medical Centre Groningen (UMCG) (Netherlands)

Sponsor details

Department of General Practice
Hanzeplein 1
Groningen
9713 GZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcg.nl/azg/nl/

Funders

Funder type

Research organisation

Funder name

Bristol-Myers Squibb (Netherlands)

Alternative name(s)

Bristol-Myers Squibb Company, BMS

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Funder name

Fund for Common Disorders from the Netherlands College of General Practitioners (Fonds Alledaagse Ziekten van het Nederlands Huisartsen Genootschap) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

University Medical Centre Groningen (UMCG) (Netherlands) - Department of General Practice

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18180279
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19860883
3. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20670438

Publication citations

  1. Results

    Peters-Veluthamaningal C, Winters JC, Groenier KH, Jong BM, Corticosteroid injections effective for trigger finger in adults in general practice: a double-blinded randomised placebo controlled trial., Ann. Rheum. Dis., 2008, 67, 9, 1262-1266, doi: 10.1136/ard.2007.073106.

  2. Results

    Peters-Veluthamaningal C, Winters JC, Groenier KH, Meyboom-de Jong B, Randomised controlled trial of local corticosteroid injections for carpal tunnel syndrome in general practice., BMC Fam Pract, 2010, 11, 54, doi: 10.1186/1471-2296-11-54.

  3. Peters-Veluthamaningal C, Winters JC, Groenier KH, Meyboom-DeJong B, Randomised controlled trial of local corticosteroid injections for de Quervain's tenosynovitis in general practice., BMC Musculoskelet Disord, 2009, 10, 131, doi: 10.1186/1471-2474-10-131.

Additional files

Editorial Notes