Carpal Tunnel SyndromeNCT00032227
Carpal Tunnel Syndrome: Diagnosis and Treatment Trial
A study testing Early Carpal Tunnel Release for Mild or Moderate CTS and MR Nerve Imaging for CTS in people with Carpal Tunnel Syndrome, run by University of Washington at 1 site in United States.
Trial summary
The Carpal Tunnel Syndrome Diagnosis and Treatment Trial is project #1 of the Multidisciplinary Clinical Research Center focused on upper extremity pain. It is a randomized trial comparing surgical and nonsurgical treatments for patients with early, mild to moderate carpal tunnel syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Early Carpal Tunnel Release for Mild or Moderate CTS and MR Nerve Imaging for CTS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2002to Apr 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Paresthesias involving 2 digits on hand diagram
- Willingness and ability to complete interviews
Who cannot join
- Evidence of denervation on EDS
- Abnormal 2-pt discrimination or thenar atrophy
- Prior wrist surgery or acute external trauma
- MRI contraindications
- Metallic hardware in wrists
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Medical Center
Seattle, Washington, 98104
About this study
The Carpal Tunnel Syndrome Diagnosis and Treatment Trial is project #1 of the Multidisciplinary Clinical Research Center focused on upper extremity pain. It is a randomized trial comparing surgical and nonsurgical treatments for patients with early, mild to moderate carpal tunnel syndrome. In addition the study will evaluate the ability of a new magnetic resonance (MR) technique at predicting who will likely benefit from carpal tunnel syndrome (CTS) surgery.
Read the detailed description
While there is good evidence that patients with severe CTS benefit from surgery, there is less evidence of a benefit for patients with mild to moderate disease. However, mild to moderate disease still accounts for important disability. Electrodiagnostic studies (EDS) have not been shown to accurately predict outcomes for patients with CTS. Recent advances in MR permit high-resolution neurographic imaging of the median nerve, and pilot data suggest that wrist MRI might be a better predictor of outcome than EDS. Thus, wrist MRI has the potential for playing a major role in the treatment of patients with CTS. We will test two main hypotheses: 1) that select patients with early, mild or moderate CTS benefit more from early surgery than with conservative therapy; and, 2) that wrist MRI accurately identifies those patients more likely to benefit from surgery. We will perform a randomized, controlled treatment trial nested within a prospective cohort as our study design.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Early Carpal Tunnel Release for Mild or Moderate CTS, MR Nerve Imaging for CTS
- Keywords
- Carpal Tunnel Release, MR Nerve Imaging, Wrist MRI
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Carpal Tunnel Release for Mild or Moderate CTSProcedure or surgery
Either open or endoscopic surgery
MR Nerve Imaging for CTSOther
New diagnostic test for CTS to directly image the median nerve
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Surgical release of CTS Receives: Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS; Other: MR Nerve Imaging for CTS |
| 2 | Active comparator | Non-surgical treatment for CTS (splint, physical therapy, ultrasound) Receives: Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS; Other: MR Nerve Imaging for CTS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carpal Tunnel Syndrome Assessment Questionnaire- function scale
Measured: 12 months
Secondary outcomes (4)
CTSAQ symptom scale
Measured: 12 months
CTSAQ-function
Measured: 3 months
CTSAQ-symptom
Measured: 3 months
SF36
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2002 (estimated)
- Study startAug 2002
- Primary completionApr 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Responsible party
- Principal investigator, Jeffrey G. Jarvik, MD, MPH, University of Washington
- Investigators
- Jeffrey G. Jarvik, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032227
- Sponsor's protocol ID
- P60AR048093
- Other IDs
- P60AR048093, NIAMS-075
- Status last verified
- May 2013
- First submitted
- 12 Mar 2002
- Last updated
- 7 May 2013
- Results posted
- No
Publications
Jarvik JG, Yuen E. Diagnosis of carpal tunnel syndrome: electrodiagnostic and magnetic resonance imaging evaluation. Neurosurg Clin N Am. 2001 Apr;12(2):241-53.
PubMed 11525204Grant GA, Britz GW, Goodkin R, Jarvik JG, Maravilla K, Kliot M. The utility of magnetic resonance imaging in evaluating peripheral nerve disorders. Muscle Nerve. 2002 Mar;25(3):314-31. doi: 10.1002/mus.10013.
PubMed 11870709Aagaard BD, Lazar DA, Lankerovich L, Andrus K, Hayes CE, Maravilla K, Kliot M. High-resolution magnetic resonance imaging is a noninvasive method of observing injury and recovery in the peripheral nervous system. Neurosurgery. 2003 Jul;53(1):199-203; discussion 203-4. doi: 10.1227/01.neu.0000069534.43067.28.
PubMed 12823890Jarvik JG, Yuen E, Haynor DR, Bradley CM, Fulton-Kehoe D, Smith-Weller T, Wu R, Kliot M, Kraft G, Wang L, Erlich V, Heagerty PJ, Franklin GM. MR nerve imaging in a prospective cohort of patients with suspected carpal tunnel syndrome. Neurology. 2002 Jun 11;58(11):1597-602. doi: 10.1212/wnl.58.11.1597.
PubMed 12058085Jarvik JG, Yuen E, Kliot M. Diagnosis of carpal tunnel syndrome: electrodiagnostic and MR imaging evaluation. Neuroimaging Clin N Am. 2004 Feb;14(1):93-102, viii. doi: 10.1016/j.nic.2004.02.002.
PubMed 15177259Martin 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 Jan 18;6:2. doi: 10.1186/1471-2474-6-2.
PubMed 15656907Storm S, Beaver SK, Giardino N, Kliot M, Franklin GM, Jarvik JG, Chan L. Compliance with electrodiagnostic guidelines for patients undergoing carpal tunnel release. Arch Phys Med Rehabil. 2005 Jan;86(1):8-11; quiz 180. doi: 10.1016/j.apmr.2004.02.027.
PubMed 15640981Jarvik 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 Sep 26;374(9695):1074-81. doi: 10.1016/S0140-6736(09)61517-8.
PubMed 19782873
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carpal Tunnel Syndrome: Diagnosis and Treatment Trial
- ClinicalTrials.gov ID
- NCT00032227
- Acronym / sponsor ID
- P60AR048093
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- Carpal Tunnel Release, MR Nerve Imaging, Wrist MRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study start
- Aug 2002
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 13 Mar 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Carpal Tunnel Syndrome Diagnosis and Treatment Trial is project #1 of the Multidisciplinary Clinical Research Center focused on upper extremity pain. It is a randomized trial comparing surgical and nonsurgical treatments for patients with early, mild to moderate carpal tunnel syndrome. In addition the study will evaluate the ability of a new magnetic resonance (MR) technique at predicting who will likely benefit from carpal tunnel syndrome (CTS) surgery.
Detailed description
While there is good evidence that patients with severe CTS benefit from surgery, there is less evidence of a benefit for patients with mild to moderate disease. However, mild to moderate disease still accounts for important disability. Electrodiagnostic studies (EDS) have not been shown to accurately predict outcomes for patients with CTS. Recent advances in MR permit high-resolution neurographic imaging of the median nerve, and pilot data suggest that wrist MRI might be a better predictor of outcome than EDS. Thus, wrist MRI has the potential for playing a major role in the treatment of patients with CTS. We will test two main hypotheses: 1) that select patients with early, mild or moderate CTS benefit more from early surgery than with conservative therapy; and, 2) that wrist MRI accurately identifies those patients more likely to benefit from surgery. We will perform a randomized, controlled treatment trial nested within a prospective cohort as our study design.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS, Other: MR Nerve Imaging for CTSSurgical release of CTS |
| 2 | Active comparator | Procedure: Early Carpal Tunnel Release for Mild or Moderate CTS, Other: MR Nerve Imaging for CTSNon-surgical treatment for CTS (splint, physical therapy, ultrasound) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Paresthesias involving 2 digits on hand diagram
- Willingness and ability to complete interviews
Key exclusion criteria (5 listed)
- Evidence of denervation on EDS
- Abnormal 2-pt discrimination or thenar atrophy
- Prior wrist surgery or acute external trauma
- MRI contraindications
- Metallic hardware in wrists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Carpal Tunnel Release for Mild or Moderate CTSEither open or endoscopic surgery | Procedure or surgery | 1, 2 |
| MR Nerve Imaging for CTSNew diagnostic test for CTS to directly image the median nerve | Other | 1, 2 |
Primary outcome
Carpal Tunnel Syndrome Assessment Questionnaire- function scale
Time frame: 12 months
4 secondary outcomes
CTSAQ symptom scale
Time frame: 12 months
CTSAQ-function
Time frame: 3 months
CTSAQ-symptom
Time frame: 3 months
SF36
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2013.
- Background: PubMed 11525204Jarvik JG, Yuen E. Diagnosis of carpal tunnel syndrome: electrodiagnostic and magnetic resonance imaging evaluation. Neurosurg Clin N Am. 2001 Apr;12(2):241-53.
- Background: PubMed 11870709Grant GA, Britz GW, Goodkin R, Jarvik JG, Maravilla K, Kliot M. The utility of magnetic resonance imaging in evaluating peripheral nerve disorders. Muscle Nerve. 2002 Mar;25(3):314-31. doi: 10.1002/mus.10013.
- Background: PubMed 12823890Aagaard BD, Lazar DA, Lankerovich L, Andrus K, Hayes CE, Maravilla K, Kliot M. High-resolution magnetic resonance imaging is a noninvasive method of observing injury and recovery in the peripheral nervous system. Neurosurgery. 2003 Jul;53(1):199-203; discussion 203-4. doi: 10.1227/01.neu.0000069534.43067.28.
- Background: PubMed 12058085Jarvik JG, Yuen E, Haynor DR, Bradley CM, Fulton-Kehoe D, Smith-Weller T, Wu R, Kliot M, Kraft G, Wang L, Erlich V, Heagerty PJ, Franklin GM. MR nerve imaging in a prospective cohort of patients with suspected carpal tunnel syndrome. Neurology. 2002 Jun 11;58(11):1597-602. doi: 10.1212/wnl.58.11.1597.
- Background: PubMed 15177259Jarvik JG, Yuen E, Kliot M. Diagnosis of carpal tunnel syndrome: electrodiagnostic and MR imaging evaluation. Neuroimaging Clin N Am. 2004 Feb;14(1):93-102, viii. doi: 10.1016/j.nic.2004.02.002.
- Background: PubMed 15656907Martin 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 Jan 18;6:2. doi: 10.1186/1471-2474-6-2.
- Background: PubMed 15640981Storm S, Beaver SK, Giardino N, Kliot M, Franklin GM, Jarvik JG, Chan L. Compliance with electrodiagnostic guidelines for patients undergoing carpal tunnel release. Arch Phys Med Rehabil. 2005 Jan;86(1):8-11; quiz 180. doi: 10.1016/j.apmr.2004.02.027.
- Derived from this study: PubMed 19782873Jarvik 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 Sep 26;374(9695):1074-81. doi: 10.1016/S0140-6736(09)61517-8.
Related trials for Carpal Tunnel Syndrome
Not yet recruitingObservational study
Postural Control and Balance Performance in Patients With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Postural Assessment
Recruiting
Comparison of Wrist Splint Positions in Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS), Peripheral Neuropathies
Recruiting
Effects of Repetitive Peripheral Magnetic Stimulation(rPMS) on CTS(Carpal Tunnel Syndrome)
Carpal Tunnel Syndrome (CTS)
Recruiting
Hand Function Outcome After the Application of Transfer Energy Capacitive and Resistive on Post-burn Patients Presented With Carpal Tunnel Syndrome
Carpal Tunnel Syndrome (CTS) Post-burn
Not yet recruiting
Effect of Progressive Gamified Motor Rehabilitation After Carpal Tunnel Release
Carpal Tunnel Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey G. Jarvik, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Carpal Tunnel Release for Mild or Moderate CTS and MR Nerve Imaging for CTS in people with Carpal Tunnel Syndrome, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carpal Tunnel Syndrome Assessment Questionnaire- function scale (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00032227, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2013.