Carpal Tunnel Syndrome Diagnosis and Treatment Trial

ISRCTN	ISRCTN84286481
DOI	https://doi.org/10.1186/ISRCTN84286481
ClinicalTrials.gov number	NCT00032227
Secondary identifying numbers	P60 AR48093

Submission date: 09/09/2004
Registration date: 26/10/2004
Last edited: 06/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jeffrey Jarvik
Scientific

Multidisciplinary Clinical Research Center
Box 359736
325 Ninth Avenue
Seattle, WA
98104
United States of America

Phone	+1 206 744 1807
Email	jarvikj@u.washington.edu

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Carpal tunnel syndrome
Intervention	Surgical release versus Conservative treatment including ultrasound.
Intervention type	Other
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 study start date	01/08/2002
Completion date	30/04/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	200
Key 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
Key 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.
Date of first enrolment	01/08/2002
Date of final enrolment	30/04/2008

Locations

Countries of recruitment

United States of America

Study participating centre

Multidisciplinary Clinical Research Center

Seattle, WA
98104
United States of America

Sponsor information

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

National Institutes of Health
1 AMS Circle
Bethesda, Maryland
20892-3675
United States of America

Phone	+1 301 495 4484 or 877 22 NIAMS
Email	KAIforNIAMS@kai-research.com
"ROR"	https://ror.org/006zn3t30

Funders

Funder type

Government

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

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?
Protocol article	protocol	18/01/2005		Yes	No
Results article	results	26/09/2009		Yes	No