Carpal Tunnel Syndrome Diagnosis and Treatment Trial
| ISRCTN | ISRCTN84286481 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84286481 |
| ClinicalTrials.gov (NCT) | NCT00032227 |
| Protocol serial number | P60 AR48093 |
| Sponsor | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (USA) |
| Funder | National Institute of Arthritis and Musculoskeletal and Skin Diseases - NIH P60 AR48093 (USA) |
- 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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Multidisciplinary Clinical Research Center
Box 359736
325 Ninth Avenue
Seattle, WA
98104
United States of America
| Phone | +1 206 744 1807 |
|---|---|
| jarvikj@u.washington.edu |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 30/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
98104
United States of America
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 26/09/2009 | Yes | No | |
| Protocol article | protocol | 18/01/2005 | Yes | No |
