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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05878509
Other study ID # 60116787-020/81396
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 29, 2018
Est. completion date March 1, 2023

Study information

Verified date May 2023
Source Pamukkale University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 170
Est. completion date March 1, 2023
Est. primary completion date March 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - patients who had traumatic hand and forearm injuries - being 18-65 years old Exclusion Criteria: - patients who have neurological, orthopedic, rheumatological disease or surgery history in the relevant extremity - patients who have communication problems

Study Design


Intervention

Other:
conducting questionnaires
The patients were administered TSK, Pain Catastrophizing Scale (PCS), Beck Anxiety Inventory (BAI) by face to face interview technique.
assesment of the severity and pain
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.

Locations

Country Name City State
Turkey Pamukkale University Denizli Kinikli

Sponsors (1)

Lead Sponsor Collaborator
Pamukkale University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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.

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

Outcome

Type Measure Description Time frame Safety issue
Primary 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, & Ulug, 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
Primary 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.
Primary 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 Modified Hand Injury Scoring System MHISS is a scoring system developed to determine injury severity in hand and forearm injuries in 4 components: integument (skin and nail), skeletal (bone and ligament), motor (tendon) and neurovascular (nerve and vascular). Each component includes absolute scores and weighted scores considering the functional importance of the affected ray. If there are additional factors such as wound contamination, a compound fracture, crush, or avulsion, the total score for each component is doubled. All anatomical structures missing due to amputation are scored as damaged. The total MHISS is obtained by summing up the scores of all components and divided into four categories as minor (<20), moderate (21-50), severe (51-100) and major (> 101) injuries (Urso-Baiarda et al., 2008). 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 Visual Analogue Scale The pain severity of the patients was evaluated using the Visual Analogue Scale (VAS). "0" indicates no pain, and "10" indicates the most severe pain perceived. Perceived pain levels were questioned during sleeping, resting and activity. 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.
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