Clinical trial NCT05023603: Social and Cognitive Factors in Carpal Tunnel Syndrome
Official title: Social Determinants of Health and Cognitive Factors in Carpal Tunnel Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Carpal Tunnel
Keywords: Chronic pain
Disability
psychosocial factors
social determinants of health
Lead sponsor: Hospital Clínico La Florida
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pain evaluation
timeFrame: Baseline (0 weeks)
measure: Disability in upper-limb
timeFrame: Baseline (0 weeks)
measure: Hand diagrams
timeFrame: Baseline (0 weeks)
Secondary outcomes:
measure: Pain Interference: Kinesiophobia
timeFrame: Baseline (0 weeks)
measure: Emotional status: Hospital Anxiety and Depression Scale (HAD).
timeFrame: Baseline (0 weeks)
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Baseline (0 weeks)
measure: Educational level
timeFrame: Baseline (0 weeks)
measure: Grip strength
timeFrame: Baseline (0 weeks)
measure: Lateral pinch strength
timeFrame: Baseline (0 weeks)
measure: Socioeconomic status
timeFrame: Baseline (0 weeks)
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Provincia Cordillera
city: Santiago
country: Chile
facility: Hospital Clínico la Florida
Study officials:
References: