Surgical decompression versus local steroid injection in carpal tunnel syndrome
| ISRCTN | ISRCTN26264638 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26264638 |
| Secondary identifying numbers | STC98 |
- Submission date
- 22/12/2011
- Registration date
- 02/02/2012
- Last edited
- 05/10/2012
- 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 (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
Contact information
Scientific
Servicio de Reumatología
University Hospital Puerta de Hierro Majadahonda
c/Manuel de Falla 2
Majadahonda
28222
Spain
| jlandreu@arrakis.es |
Study information
| Study design | Prospective randomized open comparative clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Surgical decompression versus local steroid injection in carpal tunnel syndrome: a prospective randomised trial |
| Study objectives | Steroid injection is as effective and safe as surgical decompression in carpal tunnel syndrome (CTS) |
| Ethics approval(s) | University Hospital Ramon y Cajal Ethics Committee, 14 September 1998 ref: 67/98 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/1998 |
| Completion date | 31/05/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/10/1998 |
| Date of final enrolment | 31/05/2001 |
Locations
Countries of recruitment
- Spain
Study participating centre
28222
Spain
Sponsor information
University/education
c/o Prof José Luis Andreu
Servicio de Reumatología
Manuel de Falla, 2
Majadahonda
28222
Spain
| Phone | +34 91 191 6000 |
|---|---|
| jlandreu@arrakis.es | |
"ROR" |
https://ror.org/01e57nb43 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2012 | Yes | No |
