Patient Reported Outcomes Measures (PROM) in Carpal Tunnel Therapies in Patients With Inherited Neuropathies
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Orthopedic, Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/17/2018 |
| Start Date: | June 2016 |
| End Date: | November 19, 2016 |
The purpose of this study is to learn about focal compressive median neuropathy at the wrist
(Carpal Tunnel Syndrome) and outcomes of therapies (e.g. conservative and surgery) in the
upper extremities of patients diagnosed with an inherited neuropathy. All patients enrolled
in the Rare Diseases Clinical Research Network (RDCRN) Inherited Neuropathies Consortium
(INC) Contact Registry who have marked one of the following disorders: CMT1A, CMT1B, CMT2A,
CMT4, CMTX, other known CMT peripheral neuropathy, other unknown CMT peripheral neuropathy,
or Hereditary Neuropathy with liability to Pressure Palsies (HNPP), will be invited via email
to participate in this online study.
(Carpal Tunnel Syndrome) and outcomes of therapies (e.g. conservative and surgery) in the
upper extremities of patients diagnosed with an inherited neuropathy. All patients enrolled
in the Rare Diseases Clinical Research Network (RDCRN) Inherited Neuropathies Consortium
(INC) Contact Registry who have marked one of the following disorders: CMT1A, CMT1B, CMT2A,
CMT4, CMTX, other known CMT peripheral neuropathy, other unknown CMT peripheral neuropathy,
or Hereditary Neuropathy with liability to Pressure Palsies (HNPP), will be invited via email
to participate in this online study.
An online survey will be used to assess outcomes in conservative and surgical therapies used
for carpal tunnel syndrome (CTS) in patients with a diagnosis of inherited neuropathy such as
CMT or HNPP (Charcot-Marie-Tooth disease and Hereditary Neuropathy with liability to Pressure
Palsies respectively). HNPP is an inherited neuropathy which is allelic to CMT1A. This
patient reported outcome measurement will also assess symptom severity and functional status
related to carpal tunnel syndrome (CTS) in various types of patients with inherited
neuropathy.
The survey incorporates two validated questionnaires for the evaluation of outcomes related
to carpal tunnel syndrome. The Boston Carpal Tunnel Questionnaire (BCTQ) is very specific to
carpal tunnel syndrome (CTS). The Disability of Arm, Shoulder and Hand (DASH) questionnaire
is less specific for CTS but has been shown to have equal validity in the assessment of
outcomes in CTS. The relative non-specificity of DASH for CTS can be useful in assessing the
possible contribution of CMT to the overall upper extremity symptom severity and functional
outcome. Data collected from participants with a diagnosis or therapies for CTS can be
compared to data collected from participants with no diagnosis or therapies for CTS.
Furthermore, the study will incorporate components from the CMTNS to assess the extent of CMT
disease in the participants.
It is proposed that a retrospective analysis of patients with CMT who have symptoms in the
upper extremities suggestive of carpal tunnel syndrome. Two validated questionnaires
exploring changes in symptoms and functional status (BCTQ and DASH) can be used in evaluating
outcomes of patients with reported symptoms or diagnosis of carpal tunnel syndrome.
The Boston Carpal Tunnel Questionnaire (BCTQ) is a 19 item scale which was developed
specifically for carpal tunnel syndrome and consists of 11 questions to assess symptom
severity and 8 questions to assess functional status. BCTQ has established test-retest
reliability with a good Pearson's correlation of scores on re-test (0.91 for the symptoms
severity component and 0.93 for the functional status component of the test). High internal
consistency has also been reported for the BCTQ (0.88-9.92). Convergent validity has been
demonstrated with high correlation between pre- and postoperative BCTQ scores and physical
measures such as grip, key pinch and three-jaw pinch. Responsiveness of the BCTQ after carpal
tunnel surgery has been demonstrated in randomized clinical trial settings. BCTQ has also
been reported to be 2-4 times more responsive to clinical improvement in comparison to
measures of neuromuscular impairment. High response rates have been reported with BCTQ with
80-93% at 6-12 weeks follow-up and between 67-93% at 6-12 months follow-up after carpal
tunnel release. Response rates remained high at 85% at 2 years follow-up. Mailed follow-up
response rate of 69% has been reported with a mean follow-up of 4.8 years. The mean time to
complete BCTQ has been reported to be 5.6 minutes. There is no data to indicate the precision
of BCTQ in relation to carpal tunnel syndrome.
The Disability of Arm, Shoulder and Hand (DASH) questionnaire is a 30 item scale which
assesses symptoms and physical function. This questionnaire is not specific for carpal tunnel
and can be used for a variety of disorders affecting the upper limb. DASH is intended to
measure disability through an emphasis on upper extremity activity. The test-retest
reliability of DASH has been demonstrated with a Pearson's 8 correlation of 0.9 in a group of
patients with carpal tunnel syndrome.
The validity of DASH was demonstrated through correlation with BCTQ. Pre- and postoperative
DASH scores also correlate with physical measures such as grip, key pinch and three-jaw
pinch. Responsiveness through improved DASH scores has been demonstrated at three and six
months post-surgery follow-up. BCTQ was found to be more responsive to DASH for carpal tunnel
syndrome. Postal mail response rates have been shown to be 80-93% at 6-12 weeks and 66-98% at
6 months after carpal tunnel release. The mean time to complete DASH is reported to be 6.8
minutes. There is no data to indicate the precision of DASH in relation to carpal tunnel
syndrome.
The survey data will be stored by the Rare Diseases Clinical Research Network's Data
Management and Coordinating Center (DMCC) at the University of South Florida. Names or other
personal health information will not be collected. Upon conclusion of the study period, the
data will be sent to Dr. Michael Shy, principal investigator of the Inherited Neuropathies
Consortium. Deidentified data will be sent to the database of Genotypes and Phenotypes
(dbGaP).
for carpal tunnel syndrome (CTS) in patients with a diagnosis of inherited neuropathy such as
CMT or HNPP (Charcot-Marie-Tooth disease and Hereditary Neuropathy with liability to Pressure
Palsies respectively). HNPP is an inherited neuropathy which is allelic to CMT1A. This
patient reported outcome measurement will also assess symptom severity and functional status
related to carpal tunnel syndrome (CTS) in various types of patients with inherited
neuropathy.
The survey incorporates two validated questionnaires for the evaluation of outcomes related
to carpal tunnel syndrome. The Boston Carpal Tunnel Questionnaire (BCTQ) is very specific to
carpal tunnel syndrome (CTS). The Disability of Arm, Shoulder and Hand (DASH) questionnaire
is less specific for CTS but has been shown to have equal validity in the assessment of
outcomes in CTS. The relative non-specificity of DASH for CTS can be useful in assessing the
possible contribution of CMT to the overall upper extremity symptom severity and functional
outcome. Data collected from participants with a diagnosis or therapies for CTS can be
compared to data collected from participants with no diagnosis or therapies for CTS.
Furthermore, the study will incorporate components from the CMTNS to assess the extent of CMT
disease in the participants.
It is proposed that a retrospective analysis of patients with CMT who have symptoms in the
upper extremities suggestive of carpal tunnel syndrome. Two validated questionnaires
exploring changes in symptoms and functional status (BCTQ and DASH) can be used in evaluating
outcomes of patients with reported symptoms or diagnosis of carpal tunnel syndrome.
The Boston Carpal Tunnel Questionnaire (BCTQ) is a 19 item scale which was developed
specifically for carpal tunnel syndrome and consists of 11 questions to assess symptom
severity and 8 questions to assess functional status. BCTQ has established test-retest
reliability with a good Pearson's correlation of scores on re-test (0.91 for the symptoms
severity component and 0.93 for the functional status component of the test). High internal
consistency has also been reported for the BCTQ (0.88-9.92). Convergent validity has been
demonstrated with high correlation between pre- and postoperative BCTQ scores and physical
measures such as grip, key pinch and three-jaw pinch. Responsiveness of the BCTQ after carpal
tunnel surgery has been demonstrated in randomized clinical trial settings. BCTQ has also
been reported to be 2-4 times more responsive to clinical improvement in comparison to
measures of neuromuscular impairment. High response rates have been reported with BCTQ with
80-93% at 6-12 weeks follow-up and between 67-93% at 6-12 months follow-up after carpal
tunnel release. Response rates remained high at 85% at 2 years follow-up. Mailed follow-up
response rate of 69% has been reported with a mean follow-up of 4.8 years. The mean time to
complete BCTQ has been reported to be 5.6 minutes. There is no data to indicate the precision
of BCTQ in relation to carpal tunnel syndrome.
The Disability of Arm, Shoulder and Hand (DASH) questionnaire is a 30 item scale which
assesses symptoms and physical function. This questionnaire is not specific for carpal tunnel
and can be used for a variety of disorders affecting the upper limb. DASH is intended to
measure disability through an emphasis on upper extremity activity. The test-retest
reliability of DASH has been demonstrated with a Pearson's 8 correlation of 0.9 in a group of
patients with carpal tunnel syndrome.
The validity of DASH was demonstrated through correlation with BCTQ. Pre- and postoperative
DASH scores also correlate with physical measures such as grip, key pinch and three-jaw
pinch. Responsiveness through improved DASH scores has been demonstrated at three and six
months post-surgery follow-up. BCTQ was found to be more responsive to DASH for carpal tunnel
syndrome. Postal mail response rates have been shown to be 80-93% at 6-12 weeks and 66-98% at
6 months after carpal tunnel release. The mean time to complete DASH is reported to be 6.8
minutes. There is no data to indicate the precision of DASH in relation to carpal tunnel
syndrome.
The survey data will be stored by the Rare Diseases Clinical Research Network's Data
Management and Coordinating Center (DMCC) at the University of South Florida. Names or other
personal health information will not be collected. Upon conclusion of the study period, the
data will be sent to Dr. Michael Shy, principal investigator of the Inherited Neuropathies
Consortium. Deidentified data will be sent to the database of Genotypes and Phenotypes
(dbGaP).
Inclusion Criteria:
- Diagnosis of CMT or HNPP
- Adults age 18 years and older
- Self-Registration at the Inherited Neuropathies Consortium (INC) Contact Registry
Exclusion Criteria:
- Inability to provide informed consent and complete survey
- Inability to read or speak English
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