- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05878509
Reliability and Validity of the Tampa Scale for Kinesiophobia
Reliability and Validity of the Tampa Scale for Kinesiophobia in Patients With Traumatic Hand-forearm Injuries
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Kınıklı
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Denizli, Kınıklı, Turkey, 20070
- Pamukkale University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
The patients were administered TSK, Pain Catastrophizing Scale (PCS), Beck Anxiety Inventory (BAI) by face to face interview technique.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tampa Scale for Kinesiophobia (change)
Time Frame: 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
|
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).
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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
Time Frame: 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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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).
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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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Beck Anxiety Inventory
Time Frame: 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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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).
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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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Modified Hand Injury Scoring System
Time Frame: 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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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).
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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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Visual Analogue Scale
Time Frame: 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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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.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: ALI KITIS, Professor, Pamukkale University Faculty of Physiotherapy and Rehabilitation
Publications and helpful links
General Publications
- Miller RP, Kori SH, Todd DD. The Tampa Scale: a Measure of Kinisophobia. The Clinical Journal of Pain.1991;7(1).
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 60116787-020/81396
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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