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
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
Contact information
Scientific
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Study information
| Study design | Multi-center open-label randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | ISRCTN13164336_PIS_26Sep17_V4.2.docx |
| Scientific title | The Dutch injection versus operation trial in carpal tunnel syndrome patients |
| Study acronym | DISTRICTS |
| Study objectives | Initial 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) studied | Carpal tunnel syndrome |
| Intervention | Patients 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 type | Mixed |
| Primary outcome measure | Current 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 measures | 1. 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 date | 01/12/2016 |
| Completion date | 07/06/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 940 |
| Total final enrolment | 941 |
| Key inclusion criteria | 1. 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 criteria | Current 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 enrolment | 07/11/2017 |
| Date of final enrolment | 01/11/2021 |
Locations
Countries of recruitment
- Netherlands
Study participating centres
1105 AZ Amsterdam-Zuidoost
Netherlands
6532 SZ
Netherlands
5022 GC
Netherlands
2512 VA
Netherlands
1091 AC
Netherlands
6800 TA
Netherlands
6001 BE
Netherlands
6419 PC
Netherlands
5623 EJ
Netherlands
1101 GB
Netherlands
3079 DZ
Netherlands
6001 BE
Netherlands
1502 DV
Netherlands
2353 GA
Netherlands
5623 EJ
Netherlands
5707 HA
Netherlands
2725 NA
Netherlands
6229 HX
Netherlands
3813 TZ
Netherlands
8934 AD
Netherlands
1815 JD
Netherlands
6525 GA
Netherlands
2625 AD
Netherlands
9101 DC
Netherlands
1066 EC
Netherlands
2035 RC
Netherlands
3435 CM
Netherlands
3318 AT
Netherlands
7000 AD
Netherlands
7334 DZ
Netherlands
1315 RA
Netherlands
2803 HH
Netherlands
9728 RW
Netherlands
1034 CS
Netherlands
Sponsor information
Other
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
Research organisation
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
No information available
Results and Publications
| Intention to publish date | 01/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The 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
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.
