Condition category
Musculoskeletal Diseases
Date applied
09/09/2004
Date assigned
26/10/2004
Last edited
06/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Jeffrey Jarvik

ORCID ID

Contact details

Multidisciplinary Clinical Research Center
Box 359736
325 Ninth Avenue
Seattle
WA
98104
United States of America
+1 206 744 1807
jarvikj@u.washington.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00032227

Protocol/serial number

P60 AR48093

Study information

Scientific title

Acronym

Study hypothesis

Conservative treatment remains the standard of care for treating mild to moderate carpal tunnel syndrome despite a small number of well-controlled studies and limited objective evidence to support current treatment options. There is an increasing interest in the usefulness that wrist magnetic resonance imaging could play in predicting who will benefit for various treatments. We have designed a randomised controlled trial which will assess the effectiveness of surgery for patients with mild to moderate carpal tunnel syndrome. An important secondary goal is to study the ability of MRI to predict patient outcomes.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Carpal tunnel syndrome

Intervention

Surgical release versus Conservative treatment including ultrasound.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The SF-36 Health Survey version 2 (QualityMetics Inc., Ware) has been used to assess general health status in samples of patients with a variety of diseases, including CTS. It consists of eight domains (general health, physical functioning, role limitations due to physical problems, role limitations due to emotional problems, bodily pain, social function, mental health, and vitality) scored on a scale of 0 (worst health) to 100 (ideal health). We will compare the two groups on each scale as well as the physical and mental summary scores. The generic nature of the instrument allows comparison across health conditions.

Study participants also complete the Symptom Check List SCL-90 12-item Somatization and 13-item Depression scales. Participants respond to each question using a 5-point scale ranging from "not at all" to "extremely". Higher scores indicate greater somatisation/depressive symptom severity.

Secondary outcome measures

The 13-item Pain Catastrophizing Scale is used as both a predictor and a secondary outcome. A substantial volume of research had consistently found substantial associations between pain-related catastrophising and pain-related disability. We are interested in learning whether pain-related catastrophising is a risk factor for poor outcomes in patients with CTS.

Overall trial start date

01/08/2002

Overall trial end date

30/04/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with mild to moderate carpal tunnel syndrome confirmed by electrodiagnostic study (EDS) testing
2. Must have symptoms in at least 2 digits
3. Must have completed at least a 2 week trial of standard therapy without improvement as documented by at least one of the following:
a. Improvement less than 0.75 in the Carpal Tunnel Syndrome Assessment Questionnaire (CTSAQ) functional scale
b. Unable to achieve "satisfactory" level of work
c. Patient defined symptoms as being "same" or "worse" over the last two weeks
4. EDS CRITERIA:
i. Median motor latency (wrist) ≥4.4 ms
ii. Sensory: Medial-radial (10 cm thumb to wrist) difference >0.5 ms
iii. Sensory: Midpalm median-ulnar (8 cm) difference >0.3 ms
iv. Sensory: Median-ulnar (14 cm digit IV to wrist) difference >0.4 ms
v. Sensory: Combined Sensory Index ≥1.0 ms
5. Or normal EDS with night pain that wakes patient AND Positive Flick Test
6. Other inclusion criteria:
Classic, probable or possible hand diagram
7. Willing to schedule surgery within one week of randomisation

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Patients with evidence of severe CTS on EDS, EMG, or clinical findings are excluded from the study. Severe CTS is defined as a median motor amplitude of </= 3.8 mV, EMG evidence of denervation, or thenar atrophy.

Recruitment start date

01/08/2002

Recruitment end date

30/04/2008

Locations

Countries of recruitment

United States of America

Trial participating centre

Multidisciplinary Clinical Research Center
Seattle, WA
98104
United States of America

Sponsor information

Organisation

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (USA)

Sponsor details

National Institutes of Health
1 AMS Circle
Bethesda
Maryland
20892-3675
United States of America
+1 301 495 4484 or 877 22 NIAMS
KAIforNIAMS@kai-research.com

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

National Institute of Arthritis and Musculoskeletal and Skin Diseases - NIH P60 AR48093 (USA)

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

Not provided at time of registration

Results - basic reporting

Publication summary

2005 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/15656907
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19782873

Publication citations

  1. Protocol

    Martin BI, Levenson LM, Hollingworth W, Kliot M, Heagerty PJ, Turner JA, Jarvik JG, Randomized clinical trial of surgery versus conservative therapy for carpal tunnel syndrome [ISRCTN84286481]., BMC Musculoskelet Disord, 2005, 6, 2, doi: 10.1186/1471-2474-6-2.

  2. Results

    Jarvik JG, Comstock BA, Kliot M, Turner JA, Chan L, Heagerty PJ, Hollingworth W, Kerrigan CL, Deyo RA, Surgery versus non-surgical therapy for carpal tunnel syndrome: a randomised parallel-group trial., Lancet, 2009, 374, 9695, 1074-1081, doi: 10.1016/S0140-6736(09)61517-8.

Additional files

Editorial Notes