Condition category
Nervous System Diseases
Date applied
11/02/2002
Date assigned
11/02/2002
Last edited
11/09/2008
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 Annette Gerritsen

ORCID ID

Contact details

EMGO-Institute
VU University Medical Centre
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20-444 8088
aam.gerritsen.emgo@med.vu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

OG97-013

Study information

Scientific title

Acronym

Study hypothesis

1. To determine the short and long-term efficacy of splinting compared with early surgery in relieving Carpal Tunnel Syndrome (CTS) symptoms
2. To assess from a societal perspective the cost-effectiveness of these treatment options

Ethics approval

The Medical Ethics Committees of the 13 participating hospitals approved the study protocol.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Carpal tunnel syndrome

Intervention

1. Wrist splint
2. Open carpal tunnel release

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. General improvement, scored by the patient on a 6-point ordinal transition scale, ranging from 'completely recovered' to 'much worse'
2. The number of nights that the patient awoke, due to the symptoms, during the past week
3. The severity of the most important symptoms

In order to study short and long-term treatment effects, data are collected in the hospital at baseline and at 3, 6 and 12 months after randomisation. Additional postal questionnaires are sent to the patients in the months that they do not visit the hospital (1, 2, 4, 5, 7, 8, 9, 10 and 11 months after randomisation), and again 18 months after randomisation.

Secondary outcome measures

1. Patient satisfaction, using an 11-point numerical rating scale, ranging from 0 'very unsatisfied' to 10 'completely satisfied'
2. Use of pain medication for the symptoms during the past week (yes/no)
3. The severity of symptoms and functional status, assessed by means of a self-administered questionnaire, containing two scales (the Symptom Severity Scale and the Functional Status Scale)
4. The overall severity of CTS complaints
5. Results of electrodiagnostic studies

Other outcome measures:
1. Compliance with treatment
2. Adverse effects
3. Direct and indirect costs
4. Success of blinding

In order to study short and long-term treatment effects, data are collected in the hospital at baseline and at 3, 6 and 12 months after randomisation. Additional postal questionnaires are sent to the patients in the months that they do not visit the hospital (1, 2, 4, 5, 7, 8, 9, 10 and 11 months after randomisation), and again 18 months after randomisation.

Overall trial start date

01/01/2002

Overall trial end date

01/01/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pain, paraesthesias and/or hypoesthesias in the hand, in the area innervated by the median nerve
2. Clinical diagnosis of CTS has to be confirmed by electrodiagnostic studies
3. Aged 18 years or older
4. Able to complete written questionnaires (in Dutch)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

190

Participant exclusion criteria

1. Already been treated with a wrist splint or have had previous carpal tunnel release
2. A history of wrist or median nerve injury from trauma (e.g. contusion, fractures) or prior surgery on the wrist
3. A history suggesting underlying causes of CTS, such as diabetes mellitus, thyroid disease, rheumatoid arthritis, chronic renal failure treated by hemodialysis, space-occupying lesions in the volar wrist area, anatomic abnormalities of the wrist or hand
4. Pregnancy or lactation
5. Clinical signs or symptoms, or electrodiagnostic studies suggesting conditions that could mimic CTS or interfere with its validation, such as cervical radiculopathy, brachial plexopathy, thoracic outlet syndrome, pronator teres syndrome, ulnar neuropathy, polyneuropathy, Raynaud's disease or sympathetic dystrophy
6. Severe thenar muscle atrophy

Recruitment start date

01/01/2002

Recruitment end date

01/01/2003

Locations

Countries of recruitment

Netherlands

Trial participating centre

EMGO-Institute
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

Dutch Health Care Insurance Company (The Netherlands)

Sponsor details

-
Amsterdam
-
Netherlands

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Dutch Health Care Insurance Company (The Netherlands) (ref: OG 97-013)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Anna Fonds Foundation (The Netherlands)

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

2001 protocol in http://www.ncbi.nlm.nih.gov/pubmed/11801195

Publication citations

  1. Protocol

    Gerritsen AA, Scholten RJ, Assendelft WJ, Kuiper H, de Vet HC, Bouter LM, Splinting or surgery for carpal tunnel syndrome? Design of a randomized controlled trial [ISRCTN18853827]., BMC Neurol, 2001, 1, 8.

Additional files

Editorial Notes