Plain English Summary
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?
1. Academisch Medisch Centrum (Netherlands)
2. Canisius-Wilhelmina Ziekenhuis (Netherlands)
3. Elisabeth-TweeSteden Ziekenhuis (Netherlands)
4. Haaglanden Medisch Centrum (Netherlands)
5. OLVG Amsterdam (Netherlands)
6. Rijnstate (Netherlands)
7. SJG Weert (Netherlands)
8. Zuyderland Medisch Centrum (Netherlands)
9. The Hand Clinic (Netherlands)
10. Maasstad Ziekenhuis (Netherlands)
11. Ziekenhuis St Jansdal (Netherlands)
12. Zaans MC (Netherlands)
13. Alrijne Ziekenhuis (Netherlands)
14. Catharina Ziekenhuis (Netherlands)
15. Elkerliek Ziekenhuis (Netherlands)
16. Het LangeLand Ziekenhuis (Netherlands)
17. Maastricht UMC+ (Netherlands)
18. Meander Medisch Centrum (Netherlands)
19. Medisch Centrum Leeuwarden (Netherlands)
20. Noordwest Ziekenhuisgroep (Netherlands)
21. Radboudumc (Netherlands)
22. Reinier de Graaf Gasthuis (Netherlands)
23. Sionsberg (Netherlands)
24. MC Slotervaart (Netherlands)
25. Spaarne Gasthuis (Netherlands)
26. St Antonius Ziekenhuis (Netherlands)
When is the study starting and how long is it expected to run for?
December 2016 to December 2020
Who is funding the study?
1. ZonMw
2. Zorgverzekeraars Nederland
Who is the main contact?
Prof. Rob de Bie
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
837004025
Study information
Scientific title
The Dutch injection versus operation trial in carpal tunnel syndrome patients
Acronym
DISTRICTS
Study hypothesis
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
METC AMC (Medisch Ethische Toetsingscommissie Academisch Medisch Centrum), 15/09/2017, ref: 2017_171#B2017521
Study design
Multi-center open-label randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
See additional files
Condition
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
Phase
Drug names
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 trial start date
01/12/2016
Overall trial end date
01/12/2020
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
940
Participant 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
Recruitment start date
07/11/2017
Recruitment end date
01/03/2019
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academisch Medisch Centrum
Amsterdam
1105 AZ Amsterdam-Zuidoost
Netherlands
Trial participating centre
Canisius-Wilhelmina Ziekenhuis
Nijmegen
6532 SZ
Netherlands
Trial participating centre
Elisabeth-TweeSteden Ziekenhuis
Tilburg
5022 GC
Netherlands
Trial participating centre
Haaglanden Medisch Centrum
Den Haag
2512 VA
Netherlands
Trial participating centre
OLVG Amsterdam
Amsterdam
1091 AC
Netherlands
Trial participating centre
Rijnstate
Arnhem
6800 TA
Netherlands
Trial participating centre
SJG Weert
Weert
6001 BE
Netherlands
Trial participating centre
Zuyderland Medisch Centrum
Heerlen
6419 PC
Netherlands
Trial participating centre
Catharine Ziekenhuis
Eindhoven
5623 EJ
Netherlands
Trial participating centre
The Hand Clinic
Amsterdam
1101 GB
Netherlands
Trial participating centre
Maasstad Ziekenhuis
Rotterdam
3079 DZ
Netherlands
Trial participating centre
Ziekenhuis St Jansdal
Weert
6001 BE
Netherlands
Trial participating centre
Zaans MC
Zaandam
1502 DV
Netherlands
Trial participating centre
Alrijne Ziekenhuis
Leiderdorp
2353 GA
Netherlands
Trial participating centre
Catharina Ziekenhuis
Eindhoven
5623 EJ
Netherlands
Trial participating centre
Elkerliek Ziekenhuis
Helmond
5707 HA
Netherlands
Trial participating centre
Het LangeLand Ziekenhuis
Zoetermeer
2725 NA
Netherlands
Trial participating centre
Maastricht UMC+
Maastricht
6229 HX
Netherlands
Trial participating centre
Meander Medisch Centrum
Amersfoort
3813 TZ
Netherlands
Trial participating centre
Medisch Centrum Leeuwarden
Leeuwarden
8934 AD
Netherlands
Trial participating centre
Noordwest Ziekenhuisgroep
Alkmaar
1815 JD
Netherlands
Trial participating centre
Radboudumc
Nijmegen
6525 GA
Netherlands
Trial participating centre
Reinier de Graaf Gasthuis
Delft
2625 AD
Netherlands
Trial participating centre
Sionsberg
Dokkum
9101 DC
Netherlands
Trial participating centre
MC Slotervaart
Amsterdam
1066 EC
Netherlands
Trial participating centre
Spaarne Gasthuis
Haarlem
2035 RC
Netherlands
Trial participating centre
St Antonius Ziekenhuis
Nieuwegein
3435 CM
Netherlands
Funders
Funder type
Research organisation
Funder name
ZonMw
Alternative name(s)
Netherlands Organisation for Health Research and Development
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Funder name
Zorgverzekeraars Nederland
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD sharing statement
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/12/2021
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
Publication citations
Additional files
- ISRCTN13164336_PIS_26Sep17_V4.2.docx Uploaded 26/09/2017