NCT05878509

Brief Summary

The aim of this study was to investigate the validity and reliability of the Tampa Scale for Kinesiophobia (TSK) in patients with traumatic hand and forearm injuries. A total of 170 patients with traumatic hand-forearm injuries with a mean age of 37.57±11.85 (18-63) years were included in the study. TSK, Pain Catastrophizing Scale (PCS) and Beck Anxiety Inventory (BAI) were applied to the patients in the first session. Tampa Scale for Kinesiophobia was re-administered 15 days after the first session. Test-retest reliability, internal consistency, and construct validity of the TSK were evaluated. In addition, exploratory factor analysis was applied.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 29, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 26, 2023

Completed
Last Updated

May 26, 2023

Status Verified

May 1, 2023

Enrollment Period

1.3 years

First QC Date

May 8, 2023

Last Update Submit

May 18, 2023

Conditions

Hand InjuriesForearm InjuriesTrauma

Keywords

hand injuriesforearm injurieskinesiophobiapsychometrics

Outcome Measures

Primary Outcomes (3)

  • Tampa Scale for Kinesiophobia (change)

    TSK was developed in 1991 (Miller, Kori, \& Todd, 1991), but was not published until 1995 (Liu et al., 2021). It is a 17-item scale and is scored with a 4-point Likert scale (1= Strongly disagree, 4= Strongly agree). A total score ranging from 17 to 68 was obtained after reversing items 4, 8, 12 and 16. The higher the score, the higher the kinesiophobia degree. The Turkish version of the questionnaire has been developed (Yilmaz, Yakut, Uygur, \& Uluğ, 2011). The cut-off score of the TSK has been reported as 37 (Wertli, Rasmussen-Barr, Weiser, Bachmann, \& Brunner, 2014).

    The evaluation were completed in the first session when the patient applied to the hand rehabilitation unit, and it was also repeated 15 days after the first session. The exact time is post-operative/post-injury 2nd week and 4th week. Change

  • Pain Catastrophizing Scale

    PCS is a scale developed to determine the catastrophic thoughts or feelings about pain experience and ineffective coping skills (Sullivan, Bishop, \& Pivik, 1995). It consists of 13 items and three sub-factors: helplessness, magnification and rumination. A Likert-type scale scored between 0-4 is used to obtain a total score ranging from 0 to 52. High score indicates that patients' catastrophizing levels are also high. The Turkish validity-reliability study of the questionnaire was conducted (Ugurlu, Karakas Ugurlu, Erten, \& Caykoylu, 2017).

    The evaluation were completed in the first session for once when the patient applied to the hand rehabilitation unit. The exact time is post-operative/post-injury 2nd week.

  • Beck Anxiety Inventory

    BAI is a self-report scale developed by Beck et al. and used to determine the frequency of anxiety symptoms (Beck, Epstein, Brown, \& Steer, 1988). It is a Likert-type scale consisting of 21 items each scored between 0 and 3. Turkish validity and reliability were performed by Ulusoy et al (Ulusoy, Sahin, \& Erkmen, 1998).

    The evaluation were completed in the first session for once when the patient applied to the hand rehabilitation unit. The exact time is post-operative/post-injury 2nd week.

Secondary Outcomes (2)

  • Modified Hand Injury Scoring System

    The evaluation were completed in the first session for once when the patient applied to the hand rehabilitation unit.The exact time is post-operative/post-injury 2nd week.

  • Visual Analogue Scale

    The evaluation were completed in the first session for once when the patient applied to the hand rehabilitation unit.The exact time is post-operative/post-injury 2nd week.

Study Arms (1)

patients with traumatic hand-forearm injuries

The patients between the ages of 18-65 who were referred to the hand rehabilitation unit due to traumatic hand and forearm injuries, those who did not have any neurological, orthopedic, rheumatological disease or surgery history in the relevant extremity and those who did not have communication problems were eligible to participate in the study.

Other: conducting questionnairesOther: assesment of the severity and pain

Interventions

conducting questionnairesOTHER

The patients were administered TSK, Pain Catastrophizing Scale (PCS), Beck Anxiety Inventory (BAI) by face to face interview technique.

patients with traumatic hand-forearm injuries
assesment of the severity and painOTHER

The Modified Hand Injury Scoring System (MHISS) to determine the severity of the injury, and Visual Analog Scale (VAS) to evaluate perceived pain levels were used.

patients with traumatic hand-forearm injuries

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients between the ages of 18-65 who were referred to the hand rehabilitation unit due to traumatic hand and forearm injuries, those who did not have any neurological, orthopedic, rheumatological disease or surgery history in the relevant extremity and those who did not have communication problems were eligible to participate in the study.

You may qualify if:

  • patients who had traumatic hand and forearm injuries
  • being 18-65 years old

You may not qualify if:

  • patients who have neurological, orthopedic, rheumatological disease or surgery history in the relevant extremity
  • patients who have communication problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Kınıklı, 20070, Turkey (Türkiye)

Location

Related Publications (2)

  • Miller RP, Kori SH, Todd DD. The Tampa Scale: a Measure of Kinisophobia. The Clinical Journal of Pain.1991;7(1).

    BACKGROUND

  • LUNDBERG MKE, STYF Jorma, CARLSSON SG. A psychometric evaluation of the Tampa Scale for Kinesiophobia-from a physiotherapeutic perspective. Physiotherapy theory and practice. 2004; 20(2): 121-133.

    BACKGROUND

MeSH Terms

Conditions

Hand InjuriesForearm InjuriesWounds and InjuriesKinesiophobia

Condition Hierarchy (Ancestors)

Arm InjuriesPhobic DisordersAnxiety DisordersMental Disorders

Study Officials

  • Ali Kitiş, Professor

    Pamukkale University Faculty of Physiotherapy and Rehabilitation

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 8, 2023

First Posted

May 26, 2023

Study Start

November 29, 2018

Primary Completion

March 1, 2020

Study Completion

March 1, 2023

Last Updated

May 26, 2023

Record last verified: 2023-05

Locations

TU(1)