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NCT Number: NCT06635109

Investigating the Effect of Carpal Tunnel Syndrome on Activity and Participation

The aim of our study was to examine the effect of different severities of Carpal Tunnel Syndrome on activity and participation within the framework of the International Classification of Functioning, Disability and Health (ICF).

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kutahya Health Science University

Kütahya, Turkey (Türkiye)

About this study

Individuals between the ages of 18-65 who were diagnosed with CTS in the dominant hand and who volunteered to participate in the study were included. SF-36, Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH), Michigan Hand Outcomes Questionnaire and Boston Carpal Tunnel Questionnaire - Functional Status Scale will be used to assess activity and participation. The questionnaires will be filled out via Google Forms. Shapiro-Wilk test will be performed to determine the distribution of the data. Whether the dependent variables differ between groups will be analysed by One-way ANOVA (continuous). For significant F-test, an additional investigation of differences between groups will be performed with Gabriel's post hoc procedure.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of CTS in the dominant hand
  • Being between the ages of 18-65
  • Volunteering to participate in the study

Exclusion criteria

  • Having systemic inflammatory disease
  • Having a disease that may cause polyneuropathy such as diabetes mellitus
  • Having a pacemaker
  • Having a disease affecting the central nervous system
  • Having cervical radiculopathy
  • History of previous operation or local steroid injection due to CTS

Treatment and study plan

Primary outcomes

  1. Short Form - 36 Quality of Life Questionnaire (SF-36)

    Time frame: 15 minutes

    SF-36 is a health-related quality of life questionnaire consisting of 8 scales (physical functioning, role limitations due to physical health problems, pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, mental health). Responses to items are converted into scale scores from 0 (worst health) to 100 (best health).

  2. Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH)

    Time frame: 10 minutes

    Each question in the scale is scored between 1 and 5. The results range from 0 (no difficulty or symptoms) to 100 (no activity or very severe symptoms).

  3. Michigan Hand Questionnaire (MHQ)

    Time frame: 15 minutes

    The Michigan Hand Questionnaire (MHQ) is a hand-specific questionnaire that measures the health status of patients with acute and chronic hand disorders. The MHQ is an outcome tool consisting of 37 questions and 6 domains: (1) overall hand function, (2) activities of daily living, (3) pain, (4) work performance, (5) aesthetics, and (6) patient satisfaction with function. Each domain is scored using an unweighted method by summing the responses on each scale (1 to 5) and normalising the scores to a scale from 0 to 100. A lower score indicates more severe disability, other than pain. The final score is obtained by averaging the six scores after inverting the pain score.

  4. Boston Carpal Tunnel Questionnaire - Functional Status Scale

    Time frame: 5 minutes

    It is an 8-item questionnaire used to assess the functional status of patients with CTS. Each item is scored from 1 to 5. Scores range from 1 (no functional deficit) to 5 (worst possible function). The patient's functional status score is the average of all 8 items.

Sponsors and collaborators

Lead sponsor

Kutahya Health Sciences University

Other

Registry information

Official study title

Investigation of the Effect of Different Severities of Carpal Tunnel Syndrome on Activity and Participation

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 10, 2024
Registry last updated
Mar 27, 2026

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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