The Dutch injection versus operation trial in carpal tunnel syndrome patients

ISRCTN ISRCTN13164336
DOI https://doi.org/10.1186/ISRCTN13164336
Secondary identifying numbers 837004025
Submission date
21/06/2017
Registration date
13/07/2017
Last edited
16/06/2025
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

Background and study aims
Carpal tunnel syndrome is where pressure on a nerve in the wrist causes tingling, numbness and pain in the hand and fingers. The treatment options are surgery or steroid injection, but the best treatment strategy is not known. Evidence suggests that surgery is more effective than steroid injections for relieving symptoms. However, most neurologists start treatment with steroid injections because they consider this very easy to perform and relatively safe. Because of the high frequency of continuing or returning symptoms, this strategy may result in postponement of the more effective treatment (surgery), which could lead to unnecessary illness, absence from work, and costs. The aim of this study is to find out whether starting treatment with surgery results in a better outcome compared to starting treatment with a steroid injection.

Who can participate?
Patients aged 18 or over with carpal tunnel syndrome

What does the study involve?
Participants are randomly allocated to be treated with either surgery or steroid injection. Follow-up treatment, if necessary, is at the patient and treating physician's discretion. In the 1.5 years of follow-up there are seven timepoints where patients report their symptoms and care use using questionnaires.

What are the possible benefits and risks of participating?
A higher recovery rate, faster recovery, less care use and greater patient satisfaction is expected in the surgery group compared to the injection group. The expected result has the potential to change the current treatment strategies, not only in the Netherlands, but worldwide. Surgery and steroid injections are proven, much used, low-risk treatments. There are no additional risks, only the burden of follow-up questionnaires.

Where is the study run from?
Academisch Medisch Centrum (Netherlands)

When is the study starting and how long is it expected to run for?
December 2016 to June 2023

Who is funding the study?
1. ZonMw
2. Zorgverzekeraars Nederland

Who is the main contact?
Prof. Rob de Bie

Study website

Contact information

Prof Rob de Bie
Scientific

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Study information

Study designMulti-center open-label randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet ISRCTN13164336_PIS_26Sep17_V4.2.docx
Scientific titleThe Dutch injection versus operation trial in carpal tunnel syndrome patients
Study acronymDISTRICTS
Study objectivesInitial surgical intervention in patients with CTS results in a better outcome and is cost-effective when compared to initial treatment with a steroid injection.
Ethics approval(s)METC AMC (Medisch Ethische Toetsingscommissie Academisch Medisch Centrum), 15/09/2017, ref: 2017_171#B2017521
Health condition(s) or problem(s) studiedCarpal tunnel syndrome
InterventionPatients will be randomized using a centralized web-based application. Eligible patients will be randomized in a 1:1 ratio to the initial steroid injection or the initial surgical intervention.

The injection group starts with a single corticosteroid injection. The site of injection will be at the volar side of the forearm 3-4 cm proximal to the wrist crease between the tendons of the radial flexor muscle and the long palmar muscle. Each participating center is free in using their choice of brand and dosage of steroids, with or without local anesthetic.

The surgical group starts with a decompression of the median nerve at the carpal tunnel. Any proven surgical technique for decompression of the carpal tunnel can be used.

Follow-up treatment, if necessary, is at the patient and treating physician's discretion. In the 1.5 years of follow-up there are seven timepoints where patients report their symptoms and care use on paper self-report questionnaires.
Intervention typeMixed
Primary outcome measureCurrent primary outcome measures as of 26/09/2017:
Number of patients recovered, defined as having no or mild CTS symptoms as measured with the 6-item carpal tunnel symptoms scale (CTS-6), at 18 months

Previous primary outcome measures:
1. Number of patients recovered, defined as having no or mild CTS symptoms as measured with the 6-item carpal tunnel symptoms scale (CTS-6), at 18 months
2. Time to recovery, defined as the first timepoint after the last intervention (e.g., splitting, steroid injection or surgical treatment) scoring less than 8 points if this timepoint is followed by a consecutive timepoint with a favorable outcome and no additional treatments afterwards, or if this is the last timepoint at 18 months
Secondary outcome measures1. Time to recovery, defined as the first timepoint after the last intervention (e.g., splitting, steroid injection or surgical treatment) scoring less than 8 points if this timepoint is followed by a consecutive timepoint with a favorable outcome and no additional treatments afterwards, or if this is the last timepoint at 18 months (moved from primary outcome measures to secondary outcome measures on 26/09/2017)
2. Number of patients recovered, defined as having no or mild CTS symptoms as measured with the 6-item carpal tunnel symptoms scale (CTS-6), at 6 weeks and 3, 6, 9, 12, and 15 months
3. Level of symptom severity, measured using the CTS-6 questionnaire at 6 weeks and 3, 6, 9,12, 15, and 18 months
4. Hand functioning, measured using the QuickDASH at 18 months follow-up
5. Scar or palm pain, measured using the palmar pain scale at 6 weeks, 3, 6, 9, 12, 15 and 18 months (added 09/04/2018)
5. Patient’s global perception of recovery, measured with a 7-point Likert-type item ranging from 1 (substantially deteriorated) to 7 (substantially recovered) at baseline and 18 months
6. Patient satisfaction, measured with a 7 point Likert-type item ranging from 1 (very dissatisfied) to 7 (very satisfied) at 18 months
7. Quality of life, assessed with the EuroQol (EQ-5D-5L) at 18 months
8. Number of additional treatments, defined as every treatment initiated by the neurologist after initial treatment, such as but not limited to steroid injections, (re)surgery, braces. Additional undergone treatments are determined at 6 weeks and 3, 6, 9, 12, 15, and 18 months
9. Number of adverse events, defined as the frequency, severity, nature, and duration of any adverse event throughout the course of the study. Adverse events are determined at 6 weeks and 3, 6, 9,12,15, and 18 months
10. Use of care and health-related costs during follow-up, assessed with the adapted Medical Consumption Questionnaire and the Productivity Cost Questionnaire at 3, 6, 12 and 18 months
Overall study start date01/12/2016
Completion date07/06/2023

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants940
Total final enrolment941
Key inclusion criteria1. 18 years or older at time of examination
2. Clinically suspected CTS
3. Symptoms being present for at least 6 weeks
4. Electrophysiological or sonographic confirmed CTS according to the Dutch carpal tunnel syndrome guideline
5. Treatment within 6 weeks after inclusion

Added 06/04/2018:
6. The patient can only be included for the treatment of one hand if both hands are eligible
7. Surgery and injection are both considered as potential treatments for the CTS related symptoms
Key exclusion criteriaCurrent exclusion criteria as of 06/04/2018:
1. Follow-up not possible
2. A previous history of surgery for CTS on the ipsilateral wrist
3. An injection for CTS in the ipsilateral wrist less than one year ago
4. Previously participating in the DISTRICTS
5. Clinical or neurophysiological suggestion of another diagnosis, like:
5.1. Cervical radiculopathy
5.2. Cervical myelopathy
5.3. Brachial plexopathy including thoracic outlet syndrome
5.4. Mononeuropathies, such as pronator teres syndrome
5.5. Polyneuropathy, including Hereditary Neuropathy with Liability to Pressure Palsies
5.6. Complex regional pain syndrome
6. Unable to comprehend Dutch self-report questionnaires
7. Legally incompetent adults
8. Pregnancy
9. No informed consent

Previous exclusion criteria:
1. Follow-up not possible
2. History of wrist fracture/trauma/operation
3. A previous history of injection or surgery for CTS
4. Previously participating in the DISTRICTS
5. Clinical or neurophysiological suggestion of another diagnosis that can influence CTS, like:
5.1. Cervical radiculopathy
5.2. Cervical myelopathy
5.3. Brachial plexopathy including thoracic outlet syndrome
5.4. Mononeuropathies, such as pronator teres syndrome
5.5. Polyneuropathy, including hereditary neuropathy with liability to pressure palsies
5.6. Complex regional pain syndrome
6. Secondary CTS due to known underlying cause including, but not limited to:
6.1. Thyroid disease
6.2. Rheumatoid arthritis
6.3. Diabetes mellitus
6.4. Dialysis due to kidney failure
6.5. Space-occupying lesion at the volar side of the wrist
6.6. Pregnancy
7. Known allergy to corticosteroids
8. Unable to comprehend Dutch self-report questionnaires
9. Legally incompetent adults
10. No informed consent
Date of first enrolment07/11/2017
Date of final enrolment01/11/2021

Locations

Countries of recruitment

  • Netherlands

Study participating centres

Academisch Medisch Centrum
Amsterdam
1105 AZ Amsterdam-Zuidoost
Netherlands
Canisius-Wilhelmina Ziekenhuis
Nijmegen
6532 SZ
Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg
5022 GC
Netherlands
Haaglanden Medisch Centrum
Den Haag
2512 VA
Netherlands
OLVG Amsterdam
Amsterdam
1091 AC
Netherlands
Rijnstate
Arnhem
6800 TA
Netherlands
SJG Weert
Weert
6001 BE
Netherlands
Zuyderland Medisch Centrum
Heerlen
6419 PC
Netherlands
Catharine Ziekenhuis
Eindhoven
5623 EJ
Netherlands
The Hand Clinic
Amsterdam
1101 GB
Netherlands
Maasstad Ziekenhuis
Rotterdam
3079 DZ
Netherlands
Ziekenhuis St Jansdal
Weert
6001 BE
Netherlands
Zaans MC
Zaandam
1502 DV
Netherlands
Alrijne Ziekenhuis
Leiderdorp
2353 GA
Netherlands
Catharina Ziekenhuis
Eindhoven
5623 EJ
Netherlands
Elkerliek Ziekenhuis
Helmond
5707 HA
Netherlands
Het LangeLand Ziekenhuis
Zoetermeer
2725 NA
Netherlands
Maastricht UMC+
Maastricht
6229 HX
Netherlands
Meander Medisch Centrum
Amersfoort
3813 TZ
Netherlands
Medisch Centrum Leeuwarden
Leeuwarden
8934 AD
Netherlands
Noordwest Ziekenhuisgroep
Alkmaar
1815 JD
Netherlands
Radboudumc
Nijmegen
6525 GA
Netherlands
Reinier de Graaf Gasthuis
Delft
2625 AD
Netherlands
Sionsberg
Dokkum
9101 DC
Netherlands
MC Slotervaart
Amsterdam
1066 EC
Netherlands
Spaarne Gasthuis
Haarlem
2035 RC
Netherlands
St Antonius Ziekenhuis
Nieuwegein
3435 CM
Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht
3318 AT
Netherlands
Slingeland Ziekenhuis
Doetinchem
7000 AD
Netherlands
Gelre Ziekenhuis
Apeldoorn
7334 DZ
Netherlands
Flevoziekenhuis
Almere
1315 RA
Netherlands
Groene Harts Ziekenhuis
Gouda
2803 HH
Netherlands
Martini Ziekenhuis
Groningen
9728 RW
Netherlands
BovenIJ ziekenhuis
Amsterdam
1034 CS
Netherlands

Sponsor information

Academisch Medisch Centrum
Other

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

ROR logo "ROR" https://ror.org/03t4gr691

Funders

Funder type

Research organisation

ZonMw
Private sector organisation / Other non-profit organizations
Alternative name(s)
Netherlands Organisation for Health Research and Development
Location
Netherlands
Zorgverzekeraars Nederland

No information available

Results and Publications

Intention to publish date01/09/2024
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe datasets generated during and/or analysed during the current study will be available upon request. After the completion of the trial the researchers will analyse the data and publish the relevant details. Two years after the publication of their article they will make the raw data available upon request. The request can be sent to a yet to be determined member of the steering committee. The reason for the request shall be evaluated by the steering committee and if the reason is deemed appropriate the raw data will be shared.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet version V4.2 26/09/2017 26/09/2017 No Yes
Protocol file version 5.0 29/01/2018 02/08/2023 No No
Statistical Analysis Plan version 1.0 17/07/2023 02/08/2023 No No
Results article 14/06/2025 16/06/2025 Yes No

Additional files

ISRCTN13164336_PIS_26Sep17_V4.2.docx
Uploaded 26/09/2017
ISRCTN13164336_SAP_v1.0_17Jul2023.pdf
ISRCTN13164336_Protocol_v5.0_29Jan2018.pdf

Editorial Notes

16/06/2025: Publication reference added.
10/06/2024: The intention to publish date was changed from 01/06/2024 to 01/09/2024.
02/08/2023: The following changes have been made:
1. A statistical analysis plan (SAP) has been uploaded.
2. The overall study end date has been changed from 01/06/2023 to 07/06/2023.
3. A protocol file has been uploaded.
19/01/2022: The following changes were made to the trial record:
1. The overall trial end date was changed from 01/01/2022 to 01/06/2023.
2. The intention to publish date was changed from 01/01/2023 to 01/06/2024.
10/11/2021: Total final enrolment added.
03/02/2021: Trial website added, BovenIJ ziekenhuis added as a trial participating centre.
24/05/2020: The recruitment end date has been changed from 01/06/2020 to 01/11/2021.
15/05/2020: Recruitment for this study is no longer paused.
12/05/2020: Due to current public health guidance, recruitment for this study has been paused.
09/09/2019: Trial participating centres added.
30/05/2019: IPD sharing statement added.
08/04/2019: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/03/2019 to 01/06/2020.
2. The overall trial end date was changed from 01/12/2020 to 01/01/2022.
3. The intention to publish date was changed from 01/12/2021 to 01/01/2023.
09/04/2018: The secondary outcome measures were updated.
06/04/2018: The following changes were made to the trial record:
1. Trial participating centres added.
2. Inclusion and exclusion criteria updated.
09/11/2017: The recruitment start date was changed from 27/09/2017 to 07/11/2017.
02/10/2017: The recruitment start date was changed from 25/09/2017 to 27/09/2017.
26/09/2017: The following changes were made to the trial record:
1. Ethics approval details added.
2. Trial participating centres added.
3. The recruitment start date was changed from 01/07/2017 to 25/09/2017.
4. The recruitment end date was changed from 01/01/2019 to 01/03/2019.
5. The overall trial end date was changed from 01/05/2020 to 01/12/2020.
6. Participant information sheet added.