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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
2005 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/15656907
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19782873
Publication citations
-
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.
-
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.