Condition category
Nervous System Diseases
Date applied
21/06/2017
Date assigned
13/07/2017
Last edited
09/11/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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)

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

Contact information

Type

Scientific

Primary contact

Prof Rob de Bie

ORCID ID

Contact details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

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 time points where patients report their symptoms and care use on paper self-report questionnaires.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

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

Current secondary outcome measures as of 26/09/2017:
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
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. 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

Previous secondary 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 6 weeks and 3, 6, 9, 12, and 15 months
2. Level of symptom severity, measured using the CTS-6 questionnaire at 6 weeks and 3, 6, 9,12, 15, and 18 months
3. Hand functioning, measured using the QuickDASH at 18 months follow-up
4. 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
5. Patient satisfaction, measured with a 7 point Likert-type item ranging from 1 (very dissatisfied) to 7 (very satisfied) at 18 months
6. Quality of life, assessed with the EuroQol (EQ-5D-5L) at 18 months
7. 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
8. 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
9. 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

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

940

Participant 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

Sponsor information

Organisation

Academisch Medisch Centrum

Sponsor details

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Sponsor type

Other

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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.