Social and Cognitive Factors in Carpal Tunnel Syndrome

NCT05023603 | Completed

• 1 other identifier: RNC0032018
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 2

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.

Conditions

Carpal Tunnel Syndrome; Carpal Tunnel

Keywords

Chronic pain; Disability; psychosocial factors; social determinants of health

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (7)

• Pain Interference: Kinesiophobia

  Baseline (0 weeks)

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

  Baseline (0 weeks)

• Pain Catastrophizing Scale (PCS)

  Baseline (0 weeks)

• Educational level

  Baseline (0 weeks)

• Grip strength

  Baseline (0 weeks)

Interventions

self-report questionnaire DIAGNOSTIC_TEST

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

Also known as: data collection only

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Clínico La Florida: lead

Study Sites (2)

Hospital Provincia Cordillera

Santiago, 8320000., Chile

Location

Hospital Clínico la Florida

Santiago, 8320000, Chile

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Median Neuropathy; Chronic Pain

Condition Hierarchy (Ancestors)

Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: August 26, 2021
• Study Start: October 25, 2021
• Primary Completion: June 28, 2022
• Study Completion: June 28, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

CL (2)