Carpal Tunnel SyndromeNCT05023603
Social and Cognitive Factors in Carpal Tunnel Syndrome
An observational study of Carpal Tunnel Syndrome and Carpal Tunnel, run by Hospital Clínico La Florida at 2 sites in Chile.
Trial summary
Carpal tunnel syndrome (CTS) is a compressive peripheral neuropathy, characterized by pain, tingling sensation and paresthesia in the territory of the median nerve, symptoms modulated by psychosocial factors (eg, catastrophic thinking, depression, anxiety). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carpal Tunnel Syndrome, Carpal Tunnel
- What is being tested?
- self-report questionnaire
- How many people
- 86 participants
- Where
- 2 sitesChile
- Study dates
- 25 Oct 2021to 28 Jun 2022
- How long will I take part?
- 1 Day
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Carpal tunnel syndrome (CTS) is a compressive peripheral neuropathy, characterized by pain, a tingling sensation and paraesthesia over the skin territory of the median nerve. The patient's medical history, the presence of risk factors, and the characteristics of the symptoms are key aspects for establishing a suitable differential diagnosis.
Who may be able to join
- Over 18 years of age, moderate or severe CTS medical diagnosis, duration of symptoms for more than three months, acceptance to participate in the study.
Who cannot join
- Inability to understand instructions, non-controlled mental health pathology, cognitive problems, and previous surgery in the upper limb.
Trial locations and contacts
2 sites in 1 country.
Chile2 sites
Hospital Provincia Cordillera
Santiago, 8320000.
Hospital Clínico la Florida
Santiago, 8320000
About this study
Official title: Social Determinants of Health and Cognitive Factors in Carpal Tunnel Syndrome
Carpal tunnel syndrome (CTS) is a compressive peripheral neuropathy, characterized by pain, tingling sensation and paresthesia in the territory of the median nerve, symptoms modulated by psychosocial factors (eg, catastrophic thinking, depression, anxiety).
The objective of the study is to determine those psychological and social components that influence the symptoms and function of patients with CTS.
An observational cross-sectional design will be performed in patients with CTS. The patients will be selected consecutively in two hospitals of the South East Metropolitan Health Service (Santiago, Chile). The study variables will include: Perception of pain using the Visual Analogue Scale (VAS), the extent of symptoms will be evaluated using the Katz diagram; Functional assessment using the abbreviated version of the Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH); Catastrophic thinking as a response to pain using the Pain Catastrophizing Scale (PCS), fear of movement using the Tampa Scale for Kinesiophobia (TSK-11), and emotional state was assessed using the Hospital Anxiety and Depression Scale (HADS). Both are valid and reliable measures used to evaluate the influence of psychosocial factors in patients with CTS. Individual subject factors including duration of symptoms, type of work (desk / non-desk), BMI, age, gender, educational level and economic income will be collected through an interview process.
- Conditions
- Carpal Tunnel Syndrome, Carpal Tunnel
- Being tested
- self-report questionnaire
- Keywords
- Chronic pain, Disability, psychosocial factors, social determinants of health
- Medical subject headings
- Carpal Tunnel Syndrome, Median Neuropathy, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-report questionnaireDiagnostic test
Also called data collection only
Individual subject factors included and self-report questionnaires will be collected through an interview process.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain evaluation
Pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.
Measured: Baseline (0 weeks)
Disability in upper-limb
The Perception of patients of their disability in upper-limb evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH) Spanish version Outcome Measure is a 30-item scored 1-5 (referencia). The assigned values for all completed responses are simply summed and averaged. Scoring: The assigned values for all completed responses are simply summed and averaged and higher values represent a worse Disability in upper-limb
Measured: Baseline (0 weeks)
Hand diagrams
To define total area marked for pain and numbness. The areas of the hand are marked by the patient and the marked area is quantified in square centimeters.
Measured: Baseline (0 weeks)
Secondary outcomes (7)
Pain Interference: Kinesiophobia
Kinesiophobia will be evaluated by Tampa Scale for Kinesiophobia (TSK-11SV) (Spanish adaptation. Gómez-Pérez, López-Martínez y Ruiz-Párraga, 2011). Scoring: Items are summed, with a total score from 11-44 and higher values represent a worse outcome (more pain interference in behavior).
Measured: Baseline (0 weeks)
Emotional status: Hospital Anxiety and Depression Scale (HAD).
Patient's emotional state will be evaluated by Hospital Anxiety and Depression Scale (HAD), which assess the level of anxiety and depression. Subscales and score range are Anxiety (0-21) and Depression (0-21). Scoring: items of each subscale are summed, indicating: 0-7 normality, 8-10 probably case, 11-21 anxiety or depression clinical case. Higher values represent a worse outcome.
Measured: Baseline (0 weeks)
Pain Catastrophizing Scale (PCS)
To assess catastrophic thinking as a response to pain through 13 statements with 4 possible options from 1 "not at all" to 4 "all the time". a higher score indicates a higher catastrophic thinking
Measured: Baseline (0 weeks)
Educational level
At an educational level, it will be categorized according to: complete primary education, complete secondary education and completed university studies.
Measured: Baseline (0 weeks)
Grip strength
Measured using a Jamar dynamometer (Preston, Clifton, NJ) in the second handle position, following the recommendations of the American Society of Hand Therapists
Measured: Baseline (0 weeks)
Lateral pinch strength
Measured using a pinch meter (Preston, Clifton, NJ), following the recommendations of the American Society of Hand Therapists
Measured: Baseline (0 weeks)
Socioeconomic status
This indicator is calculated by dividing the effective income of each family by its index of needs. Effective income: monthly average of income received, including work, capital and pensions.
Measured: Baseline (0 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start25 Oct 2021
- Primary completion28 Jun 2022
- Study completion28 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 86 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Hospital Clínico La Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Ignacio Nunez Cortes, Hospital Clínico La Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05023603
- Sponsor's protocol ID
- RNC0032018
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2021
- Last updated
- 3 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Determinants of Health and Cognitive Factors in Carpal Tunnel Syndrome
- ClinicalTrials.gov ID
- NCT05023603
- Acronym / sponsor ID
- RNC0032018
- Conditions
- Carpal Tunnel Syndrome, Carpal Tunnel
- Keywords
- Chronic pain, Disability, psychosocial factors, social determinants of health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Hospital Clínico La FloridaUniversity, hospital or other
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 28 Jun 2022 (actual)
- Study completion
- 28 Jun 2022 (actual)
- First posted
- 26 Aug 2021 (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 (CTS) is a compressive peripheral neuropathy, characterized by pain, tingling sensation and paresthesia in the territory of the median nerve, symptoms modulated by psychosocial factors (eg, catastrophic thinking, depression, anxiety).
The objective of the study is to determine those psychological and social components that influence the symptoms and function of patients with CTS.
An observational cross-sectional design will be performed in patients with CTS. The patients will be selected consecutively in two hospitals of the South East Metropolitan Health Service (Santiago, Chile). The study variables will include: Perception of pain using the Visual Analogue Scale (VAS), the extent of symptoms will be evaluated using the Katz diagram; Functional assessment using the abbreviated version of the Disabilities of the Arm, Shoulder and Hand Questionnaire (QuickDASH); Catastrophic thinking as a response to pain using the Pain Catastrophizing Scale (PCS), fear of movement using the Tampa Scale for Kinesiophobia (TSK-11), and emotional state was assessed using the Hospital Anxiety and Depression Scale (HADS). Both are valid and reliable measures used to evaluate the influence of psychosocial factors in patients with CTS. Individual subject factors including duration of symptoms, type of work (desk / non-desk), BMI, age, gender, educational level and economic income will be collected through an interview process.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Carpal tunnel syndrome (CTS) is a compressive peripheral neuropathy, characterized by pain, a tingling sensation and paraesthesia over the skin territory of the median nerve. The patient's medical history, the presence of risk factors, and the characteristics of the symptoms are key aspects for establishing a suitable differential diagnosis.
Key inclusion criteria (1 listed)
- Over 18 years of age, moderate or severe CTS medical diagnosis, duration of symptoms for more than three months, acceptance to participate in the study.
Key exclusion criteria (1 listed)
- Inability to understand instructions, non-controlled mental health pathology, cognitive problems, and previous surgery in the upper limb.
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 |
|---|---|---|
| self-report questionnaireAlso: data collection onlyIndividual subject factors included and self-report questionnaires will be collected through an interview process. | Diagnostic test | – |
Primary outcome
Pain evaluation
Time frame: Baseline (0 weeks)
Pain will be measured by the Visual Analog Scale for pain (VAS) from 0 to 10, where higher values represent a worse outcome.
Disability in upper-limb
Time frame: Baseline (0 weeks)
The Perception of patients of their disability in upper-limb evaluated by The Disabilities of the Arm, Shoulder and Hand (DASH) Spanish version Outcome Measure is a 30-item scored 1-5 (referencia). The assigned values for all completed responses are simply summed and averaged. Scoring: The assigned values for all completed responses are simply summed and averaged and higher values represent a worse Disability in upper-limb
Hand diagrams
Time frame: Baseline (0 weeks)
To define total area marked for pain and numbness. The areas of the hand are marked by the patient and the marked area is quantified in square centimeters.
7 secondary outcomes
Pain Interference: Kinesiophobia
Time frame: Baseline (0 weeks)
Emotional status: Hospital Anxiety and Depression Scale (HAD).
Time frame: Baseline (0 weeks)
Pain Catastrophizing Scale (PCS)
Time frame: Baseline (0 weeks)
Educational level
Time frame: Baseline (0 weeks)
Grip strength
Time frame: Baseline (0 weeks)
Lateral pinch strength
Time frame: Baseline (0 weeks)
Socioeconomic status
Time frame: Baseline (0 weeks)
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 3 Aug 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Carpal Tunnel, run by Hospital Clínico La Florida at 2 sites in Chile.
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 1 inclusion and 1 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 3 Aug 2022. 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 Chile. 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?
Pain evaluation (time frame: Baseline (0 weeks)). 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?
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 3 Aug 2022; AzTrials last refreshed its copy on 8 Nov 2026.