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Completed

NCT Number: NCT05023603

Social 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.

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Key information

Conditions

Carpal Tunnel Syndrome Carpal Tunnel Chronic Pain Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico la Florida, Santiago, Chile

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Inability to understand instructions, non-controlled mental health pathology, cognitive problems, and previous surgery in the upper limb.

Treatment and study plan

self-report questionnaire

Diagnostic Test

Individual subject factors included and self-report questionnaires will be collected through an interview process.

Other names: data collection only

Primary outcomes

  1. 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.

  2. 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

  3. 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.

Secondary outcomes

  1. Pain Interference: Kinesiophobia

    Time frame: Baseline (0 weeks)

    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).

  2. Emotional status: Hospital Anxiety and Depression Scale (HAD).

    Time frame: Baseline (0 weeks)

    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.

  3. Pain Catastrophizing Scale (PCS)

    Time frame: Baseline (0 weeks)

    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

  4. Educational level

    Time frame: Baseline (0 weeks)

    At an educational level, it will be categorized according to: complete primary education, complete secondary education and completed university studies.

  5. Grip strength

    Time frame: Baseline (0 weeks)

    Measured using a Jamar dynamometer (Preston, Clifton, NJ) in the second handle position, following the recommendations of the American Society of Hand Therapists

  6. Lateral pinch strength

    Time frame: Baseline (0 weeks)

    Measured using a pinch meter (Preston, Clifton, NJ), following the recommendations of the American Society of Hand Therapists

  7. Socioeconomic status

    Time frame: Baseline (0 weeks)

    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.

Sponsors and collaborators

Lead sponsor

Hospital Clínico La Florida

Other

Registry information

Official study title

Social Determinants of Health and Cognitive Factors in Carpal Tunnel Syndrome

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2021
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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