Social and Cognitive Factors in Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

Social Determinants of Health and Cognitive Factors in Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05023603
• Other study ID #: RNC0032018
• Status: Completed
• Start date: October 25, 2021
• Est. completion date: June 28, 2022

Study information

• Verified date: August 2022
• Source: Hospital Clínico La Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 28, 2022
• Est. primary completion date: June 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel
• Carpal Tunnel Syndrome
• Syndrome

Intervention

Diagnostic Test:
• self-report questionnaire
Individual subject factors included and self-report questionnaires will be collected through an interview process.

Locations

Country	Name	City	State
Chile	Hospital Clínico la Florida	Santiago
Chile	Hospital Provincia Cordillera	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clínico La Florida

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline (0 weeks)
Primary	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	Baseline (0 weeks)
Primary	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.	Baseline (0 weeks)
Secondary	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).	Baseline (0 weeks)
Secondary	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.	Baseline (0 weeks)
Secondary	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	Baseline (0 weeks)
Secondary	Educational level	At an educational level, it will be categorized according to: complete primary education, complete secondary education and completed university studies.	Baseline (0 weeks)
Secondary	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	Baseline (0 weeks)
Secondary	Lateral pinch strength	Measured using a pinch meter (Preston, Clifton, NJ), following the recommendations of the American Society of Hand Therapists	Baseline (0 weeks)
Secondary	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.	Baseline (0 weeks)