Carpal Tunnel SyndromeNCT03782558
Validation of the Polish Version of the Boston Carpal Tunnel Syndrome Questionnaire
An observational study of Carpal Tunnel Syndrome, run by Jakub Antczak at 2 sites in Poland.
Trial summary
Carpal tunnel syndrome is the most common compression neuropathy. The compression of the median nerve occurs in the carpal tunnel and results in pain and other unpleasant sensations in hand and wrist. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Surgical transection of transverse ligament
- Type of treatment
- Surgery or procedure
- How many people
- 130 participants
- Where
- 2 sitesPoland
- Study dates
- 22 Jan 2019to 9 Sep 2023
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from the patients referred to Krakowska Akademia Neurologii Centrum Neurologii Klinicznej for electrohysiologic verification of their initial, clinical diagnosis of CTS. After the electrophysiology confirms the CTS, the patient will be asked if she/he would like to take part in the study.
Who may be able to join
- Presence of at least one symptom within hand and / or wrist, from the following: paresthesias, sensory loss, tingling, burning sensation, impression of swelling.
- Electrophysiologic confirmation of CTS, which will base on the abnormal latency difference in sensory or motor conduction between median and ulnar nerve or on sensory conduction slowing in median nerve, or on the prolongation of distal motor latency of the median nerve.
- (bilateral CTS will be included. pBCTQ will be filled out separately for each hand and the outcomes wil be measured separately for each hand).
Who cannot join
- Clinical signs or symptoms and /or electrophysiologic results indicative of more generalized peripheral neuropathy.
- Presence of conditions, which may lead to the development of peripheral neuropathy such as diabetes, renal insufficiency, hypothyroidism or amyloidosis.
- Presence of conditions, which may clinically resemble CTS, such as cervical radiculopathy or myelopathy or thoracic outlet syndrome
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Krakowska Akademia Neurologii Centrum Neurologii Klinicznej
Krakow, 31505
Jagiellonian University Medical College
Krakow
About this study
Carpal tunnel syndrome is the most common compression neuropathy. The compression of the median nerve occurs in the carpal tunnel and results in pain and other unpleasant sensations in hand and wrist. In more advanced stage, weakness and wasting of the thenar and other muscles innervated by median nerve occurs, which may lead to permanent impairment of manual performance. The Boston carpal tunnel questionnaire (BCTQ) is one of the most commonly used tools for monitoring of the disease progression and of the effect of therapy. Originally created in English, it has been translated into many languages and subsequently validated. Recently the Polish version has been created and the purpose of this study is to validate it.
Read the detailed description
Carpal tunnel syndrome (CTS) is the most common compression neuropathy. The compression of the median nerve occurs in the carpal tunnel and results in pain and other unpleasant sensations in hand and wrist. In more advanced stage, weakness and wasting of the thenar and other muscles innervated by median nerve occurs, which may lead to permanent impairment of manual performance. The Boston carpal tunnel questionnaire (BCTQ) (Levine et al. 1993) is one of the most commonly used tools for monitoring of the disease progression and of the effect of therapy. It is a self administered questionnaire, which consists of two subscales, the Symptom severity scale and the Functional status scale. In the first one, the severity of particular symptoms is rated between none or never to very severe or continuous where appropriate. In the second one, the difficulties in performing several typical daily tasks, requiring manual activity is rated between "no difficulty" to "cannot perform activity at all due to hands and wrists symptoms". Originally created in English, it has been translated into many languages and subsequently validated. Recently the Polish version has been created (Polish version of the Boston Carpal Tunnel Questionnaire - pBCTQ) and the purpose of this study is to validate it. The translation from English to Polish has been independently made by two health professionals, native Polish speakers with good acquired knowledge of English. Next, both Polish versions were independently backward-translated to English, by two native English speakers with good acquired knowledge of Polish. Finally, all translators met together and all translations were presented to everyone of them. Possible mistakes in translations from original version into Polish, which might led to discrepancies between backwardly translated versions (from Polish to English) and the original version were discussed and the final version was created. The first step of the study on validation of the Polish version will be the pre-testing. In this step, pBCTQ will be administered to small sample of patients (ten in this study) and the investigators will interview in detail how these participants understand each question of the questionnaire. If pre-testing reveals that patients may understand any question differently from its meaning in the original version, final adjustments will be discussed among the translators and possibly introduced.
The final pBCTQ will be administered before and after surgical treatment to the convenience group of 120 patients with electrodiagnostically confirmed CTS. Moreover, 30 randomly selected patients will be asked to fill out pBCTQ additionally, two weeks after first administration but before surgical treatment. Data from this subgroup will serve to assess the test-retest reliability. pBCTQ will be tested also regarding its consistency, validity and reactivity.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Surgical transection of transverse ligament
- Keywords
- carpal tunnel syndrome, pBCTQ, validation, nerve conduction study
- 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.
Surgical transection of transverse ligamentProcedure or surgery
Also called Surgical transection of flexor retinaculum
Standard therapy for CTS. An incision is made at the base of the palm of the hand. Then the transverse ligament is cut, which releases the compression of the median nerve and improves the symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Patients with CTS | Surgical transection of transverse ligament Receives: Procedure: Surgical transection of transverse ligament |
What is being measured
The primary outcome is the main question the study is designed to answer.
Internal Consistency
Consistency between two subscales of pBCTQ (Symptom severity scale and Functional status scale) will be evaluated using Cronbach alfa test.
Measured: Through study completion, an average of six months.
Validity
Validity will be tested by calculating the correlation of the subscore of each of two parts of the questionnaire with the electrophysiologic, six-grade severity level according to Padua et al. (1997).
Measured: Through study completion, an average of six months.
Reactivity: Correlation between changes in pBCTQ and electrophysiologic severity of CTS
The reactivity will be evaluated as correlation between change in electrophysiologic severity level of CTS and changes in both pBCTQ subscales after treatment.
Measured: Before treatment and then three months after surgical treatment of CTS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start22 Jan 2019
- Primary completion1 Sep 2023
- Study completion9 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jakub Antczak
- Sponsor type
- University, hospital or other
- Collaborators
- Centrum Neurologii Klinicznej Krakowska Akademia Neurologii
- Responsible party
- Sponsor-investigator, Jakub Antczak, Jagiellonian University
- Investigators
- Jakub Antczak, MD, Principal investigator, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03782558
- Sponsor's protocol ID
- JagiellonianU60
- Status last verified
- Sep 2023
- First submitted
- 8 Dec 2018
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Padua L, LoMonaco M, Gregori B, Valente EM, Padua R, Tonali P. Neurophysiological classification and sensitivity in 500 carpal tunnel syndrome hands. Acta Neurol Scand. 1997 Oct;96(4):211-7. doi: 10.1111/j.1600-0404.1997.tb00271.x.
PubMed 9325471Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.
PubMed 8245050
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Polish Version of the Boston Carpal Tunnel Syndrome Questionnaire
- ClinicalTrials.gov ID
- NCT03782558
- Acronym / sponsor ID
- JagiellonianU60
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, pBCTQ, validation, nerve conduction study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Jakub AntczakUniversity, hospital or other
- Collaborators
- Centrum Neurologii Klinicznej Krakowska Akademia Neurologii
- Study start
- 22 Jan 2019 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 9 Sep 2023 (actual)
- First posted
- 20 Dec 2018 (actual)
- 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.
Carpal tunnel syndrome is the most common compression neuropathy. The compression of the median nerve occurs in the carpal tunnel and results in pain and other unpleasant sensations in hand and wrist. In more advanced stage, weakness and wasting of the thenar and other muscles innervated by median nerve occurs, which may lead to permanent impairment of manual performance. The Boston carpal tunnel questionnaire (BCTQ) is one of the most commonly used tools for monitoring of the disease progression and of the effect of therapy. Originally created in English, it has been translated into many languages and subsequently validated. Recently the Polish version has been created and the purpose of this study is to validate it.
Detailed description
Carpal tunnel syndrome (CTS) is the most common compression neuropathy. The compression of the median nerve occurs in the carpal tunnel and results in pain and other unpleasant sensations in hand and wrist. In more advanced stage, weakness and wasting of the thenar and other muscles innervated by median nerve occurs, which may lead to permanent impairment of manual performance. The Boston carpal tunnel questionnaire (BCTQ) (Levine et al. 1993) is one of the most commonly used tools for monitoring of the disease progression and of the effect of therapy. It is a self administered questionnaire, which consists of two subscales, the Symptom severity scale and the Functional status scale. In the first one, the severity of particular symptoms is rated between none or never to very severe or continuous where appropriate. In the second one, the difficulties in performing several typical daily tasks, requiring manual activity is rated between "no difficulty" to "cannot perform activity at all due to hands and wrists symptoms". Originally created in English, it has been translated into many languages and subsequently validated. Recently the Polish version has been created (Polish version of the Boston Carpal Tunnel Questionnaire - pBCTQ) and the purpose of this study is to validate it. The translation from English to Polish has been independently made by two health professionals, native Polish speakers with good acquired knowledge of English. Next, both Polish versions were independently backward-translated to English, by two native English speakers with good acquired knowledge of Polish. Finally, all translators met together and all translations were presented to everyone of them. Possible mistakes in translations from original version into Polish, which might led to discrepancies between backwardly translated versions (from Polish to English) and the original version were discussed and the final version was created. The first step of the study on validation of the Polish version will be the pre-testing. In this step, pBCTQ will be administered to small sample of patients (ten in this study) and the investigators will interview in detail how these participants understand each question of the questionnaire. If pre-testing reveals that patients may understand any question differently from its meaning in the original version, final adjustments will be discussed among the translators and possibly introduced.
The final pBCTQ will be administered before and after surgical treatment to the convenience group of 120 patients with electrodiagnostically confirmed CTS. Moreover, 30 randomly selected patients will be asked to fill out pBCTQ additionally, two weeks after first administration but before surgical treatment. Data from this subgroup will serve to assess the test-retest reliability. pBCTQ will be tested also regarding its consistency, validity and reactivity.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with CTS | – | Procedure: Surgical transection of transverse ligamentSurgical transection of transverse ligament |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the patients referred to Krakowska Akademia Neurologii Centrum Neurologii Klinicznej for electrohysiologic verification of their initial, clinical diagnosis of CTS. After the electrophysiology confirms the CTS, the patient will be asked if she/he would like to take part in the study.
Key inclusion criteria (3 listed)
- Presence of at least one symptom within hand and / or wrist, from the following: paresthesias, sensory loss, tingling, burning sensation, impression of swelling.
- Electrophysiologic confirmation of CTS, which will base on the abnormal latency difference in sensory or motor conduction between median and ulnar nerve or on sensory conduction slowing in median nerve, or on the prolongation of distal motor latency of the median nerve.
- (bilateral CTS will be included. pBCTQ will be filled out separately for each hand and the outcomes wil be measured separately for each hand).
Key exclusion criteria (3 listed)
- Clinical signs or symptoms and /or electrophysiologic results indicative of more generalized peripheral neuropathy.
- Presence of conditions, which may lead to the development of peripheral neuropathy such as diabetes, renal insufficiency, hypothyroidism or amyloidosis.
- Presence of conditions, which may clinically resemble CTS, such as cervical radiculopathy or myelopathy or thoracic outlet syndrome
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 |
|---|---|---|
| Surgical transection of transverse ligamentAlso: Surgical transection of flexor retinaculumStandard therapy for CTS. An incision is made at the base of the palm of the hand. Then the transverse ligament is cut, which releases the compression of the median nerve and improves the symptoms. | Procedure or surgery | Patients with CTS |
Primary outcome
Internal Consistency
Time frame: Through study completion, an average of six months.
Consistency between two subscales of pBCTQ (Symptom severity scale and Functional status scale) will be evaluated using Cronbach alfa test.
Validity
Time frame: Through study completion, an average of six months.
Validity will be tested by calculating the correlation of the subscore of each of two parts of the questionnaire with the electrophysiologic, six-grade severity level according to Padua et al. (1997).
Reactivity: Correlation between changes in pBCTQ and electrophysiologic severity of CTS
Time frame: Before treatment and then three months after surgical treatment of CTS
The reactivity will be evaluated as correlation between change in electrophysiologic severity level of CTS and changes in both pBCTQ subscales after treatment.
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 13 Sep 2023.
- Background: PubMed 9325471Padua L, LoMonaco M, Gregori B, Valente EM, Padua R, Tonali P. Neurophysiological classification and sensitivity in 500 carpal tunnel syndrome hands. Acta Neurol Scand. 1997 Oct;96(4):211-7. doi: 10.1111/j.1600-0404.1997.tb00271.x.
- Background: PubMed 8245050Levine DW, Simmons BP, Koris MJ, Daltroy LH, Hohl GG, Fossel AH, Katz JN. A self-administered questionnaire for the assessment of severity of symptoms and functional status in carpal tunnel syndrome. J Bone Joint Surg Am. 1993 Nov;75(11):1585-92. doi: 10.2106/00004623-199311000-00002.
- Individual participant dataSharing planned: Undecided
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.
Jakub Antczak, MD principal investigator
Jagiellonian University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carpal Tunnel Syndrome, run by Jakub Antczak at 2 sites in Poland.
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 3 inclusion and 3 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 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. 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?
Internal Consistency (time frame: Through study completion, an average of six months.). The study lists 3 primary outcomes in all. 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 NCT03782558, which also lists 2 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 13 Sep 2023.