ISRCTN - ISRCTN26264638: Surgical decompression versus local steroid injection in carpal tunnel syndrome

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
jlandreu@arrakis.es

Trial website

Contact information

Type

Scientific

Primary contact

Prof José Luis Andreu

ORCID ID

Contact details

Servicio de Reumatología
University Hospital Puerta de Hierro Majadahonda
c/Manuel de Falla 2
Majadahonda
28222
Spain
jlandreu@arrakis.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

STC98

Study information

Scientific title

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

Acronym

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

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Carpal tunnel syndrome

Intervention

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 12 cm in depth, and then paramethasone acetonide, 20mg in 1ml, is instilled.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measure

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

01/10/1998

Overall trial end date

31/05/2001

Reason abandoned (if study stopped)

Eligibility

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

Patient

Age group

Adult

Gender

Both

Target number of participants

100

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

01/10/1998

Recruitment end date

31/05/2001

Locations

Countries of recruitment

Spain

Trial participating centre

Servicio de Reumatología
Majadahonda
28222
Spain

Sponsor information

Organisation

University Hospital Puerta de Hierro Majadahonda (Spain)

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Spanish National Health System (Spain)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data