Splinting or surgery for carpal tunnel syndrome

ISRCTN	ISRCTN18853827
DOI	https://doi.org/10.1186/ISRCTN18853827
Protocol serial number	OG97-013
Sponsor	Dutch Health Care Insurance Company (The Netherlands)
Funders	Dutch Health Care Insurance Company (The Netherlands) (ref: OG 97-013), Anna Fonds Foundation (The Netherlands)

Submission date: 11/02/2002
Registration date: 11/02/2002
Last edited: 27/10/2022

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 Annette Gerritsen
Scientific

EMGO-Institute
VU University Medical Centre
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20-444 8088
Email	aam.gerritsen.emgo@med.vu.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Splinting or surgery for carpal tunnel syndrome
Study objectives	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(s)	The Medical Ethics Committees of the 13 participating hospitals approved the study protocol.
Health condition(s) or problem(s) studied	Carpal tunnel syndrome
Intervention	1. Wrist splint 2. Open carpal tunnel release
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/01/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	190
Total final enrolment	176
Key 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)
Key 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
Date of first enrolment	01/01/2002
Date of final enrolment	01/01/2003

Locations

Countries of recruitment

Netherlands

Study participating centre

EMGO-Institute

Amsterdam
1081 BT
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article		11/09/2002	27/10/2022	Yes	No
Protocol article		18/12/2001		Yes	No

Editorial Notes

27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.