Condition category
Nervous System Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Carpal tunnel syndrome (CTS) is a condition due to the median nerve in the wrist being trapped. This irritates the median nerve and produces a wide variety of symptoms, such as pain or numbness in the hand.
To date, there are only two treatments that are known to work:
1. Local corticosteroid injection in the wrist
2. Surgical decompression of the nerve
The objective of this study is to compare the two forms of treatment.

Who can participate?
You can participate in the study if you are 18 year old or older and your doctor thinks you have CTS.

What does the study involve?
A group of wrists are treated with surgical decompression and another group of wrists are treated with one or two local corticosteroid injections. The results of the treatment will be followed for two years.

What are the possible benefits and risks of participating?
Participants are treated with one out of two well established treatments so there will not be risks. Benefits of participating include being treated for the condition. Expected side effects are local discomfort for several days after the injection or the surgical decompression.

Where is the study run from?
The study is carried out in Centro de Salud Gandhi, Madrid and in Hospital Universitario Ramón y Cajal, Madrid, Spain.

When is study starting and how long is it expected to run for?
The study started on 01 October 1998 and finished on 31 May 31 2001.

Who is funding the study?
Spanish National Health System

Who is the main contact?
Prof José Luis Andreu

Trial website

Contact information



Primary contact

Prof José Luis Andreu


Contact details

Servicio de Reumatología
University Hospital Puerta de Hierro Majadahonda
c/Manuel de Falla 2

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title

Surgical decompression versus local steroid injection in carpal tunnel syndrome: a prospective randomised trial


Study hypothesis

Steroid injection is as effective and safe as surgical decompression in carpal tunnel syndrome (CTS)

Ethics approval

University Hospital Ramon y Cajal Ethics Committee, 14 September 1998 ref: 67/98

Study design

Prospective randomized open comparative clinical trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Carpal tunnel syndrome


Local steroid injection versus surgical decompression for new-onset CTS.

All surgical procedures are performed on an outpatient basis using a limited palmar incision technique. Local steroid injections are performed using a standard technique: the steroid is instilled beneath the transverse carpal ligament from the ulnar side of the wrist. A 22-gauge needle is positioned 1 cm proximal to the distal wrist-flexion crease and medial to the palmaris longus tendon. The needle is passed at a 45 degree angle distally and advanced 1–2 cm in depth, and then paramethasone acetonide, 20mg in 1ml, is instilled.

Intervention type



Not Applicable

Drug names

Primary outcome measures

Percentage of wrists reaching at least a 20% reduction in the VAS score for nocturnal paresthesias at 3 months of follow up.

Secondary outcome measures

Percentages of wrists with a 20% reduction in the VAS score for nocturnal paresthesias at 6 and 12 months, a 20% response for pain and functional impairment, as well as a 50% and a 70% response in nocturnal paresthesias, pain, and functional impairment.

Overall trial start date


Overall trial end date


Reason abandoned


Participant inclusion criteria

1. At least 18 years old
2. Symptoms of CTS of at least 3 months’ duration
3. Referred by their primary care physicians to a CTS unit specifically created for this study
4. A presumptive diagnosis of CTS, and had been unresponsive to a course of at least 2 weeks of non-steroidal anti-inflammatory drugs (NSAIDs) and splinting.
5. CTS confirmed by electrodiagnostic testing according to Kimura´s criteria.

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Patients with wrists with thenar atrophy
2. Previous carpal tunnel release surgery, or local injection for CTS
3. Patients who are pregnant
4. Patients which have diabetes mellitus
5. Patients which have hypothyroidism
6. Patients which have inflammatory arthropathy
7. Patients which have polyneuropathy

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Servicio de Reumatología

Sponsor information


University Hospital Puerta de Hierro Majadahonda (Spain)

Sponsor details

c/o Prof José Luis Andreu
Servicio de Reumatología
Manuel de Falla
+34 91 191 6000

Sponsor type




Funder type

Hospital/treatment centre

Funder name

Spanish National Health System (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in

Publication citations

  1. Results

    Ly-Pen D, Andréu JL, Millán I, de Blas G, Sánchez-Olaso A, Comparison of surgical decompression and local steroid injection in the treatment of carpal tunnel syndrome: 2-year clinical results from a randomized trial., Rheumatology (Oxford), 2012, 51, 8, 1447-1454, doi: 10.1093/rheumatology/kes053.

Additional files

Editorial Notes