Hand InjuriesNCT05878509
Reliability and Validity of the Tampa Scale for Kinesiophobia
An observational study of Hand Injuries and Forearm Injuries, run by Pamukkale University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hand Injuries, Forearm Injuries, Trauma
- What is being tested?
- conducting questionnaires and assesment of the severity and pain
- How many people
- 170 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Nov 2018to 1 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- patients who had traumatic hand and forearm injuries
- being 18-65 years old
Who cannot join
- patients who have neurological, orthopedic, rheumatological disease or surgery history in the relevant extremity
- patients who have communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Hand Injuries, Forearm Injuries, Trauma
- Being tested
- conducting questionnaires, assesment of the severity and pain
- Keywords
- hand injuries, forearm injuries, kinesiophobia, psychometrics
- Medical subject headings
- Hand Injuries, Forearm Injuries, Wounds and Injuries, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conducting questionnairesOther
The patients were administered TSK, Pain Catastrophizing Scale (PCS), Beck Anxiety Inventory (BAI) by face to face interview technique.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: conducting questionnaires; Other: assesment of the severity and pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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
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).
Measured: 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 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2023
- Study start29 Nov 2018
- Primary completion1 Mar 2020
- Study completion1 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hand InjuriesStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, UMUT ERASLAN, Pamukkale University
- Investigators
- Ali Kitiş, Professor, Study chair, Pamukkale University Faculty of Physiotherapy and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05878509
- Sponsor's protocol ID
- 60116787-020/81396
- Status last verified
- May 2023
- First submitted
- 8 May 2023
- Last updated
- 26 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data is available to other researchers upon request.
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 at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability and Validity of the Tampa Scale for Kinesiophobia in Patients With Traumatic Hand-forearm Injuries
- ClinicalTrials.gov ID
- NCT05878509
- Acronym / sponsor ID
- 60116787-020/81396
- Conditions
- Hand Injuries, Forearm Injuries, Trauma
- Keywords
- hand injuries, forearm injuries, kinesiophobia, psychometrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 29 Nov 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Mar 2023 (actual)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with traumatic hand-forearm injuries | – | Other: conducting questionnaires, Other: assesment of the severity and painThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- patients who had traumatic hand and forearm injuries
- being 18-65 years old
Key exclusion criteria (2 listed)
- patients who have neurological, orthopedic, rheumatological disease or surgery history in the relevant extremity
- patients who have communication problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conducting questionnairesThe patients were administered TSK, Pain Catastrophizing Scale (PCS), Beck Anxiety Inventory (BAI) by face to face interview technique. | Other | patients with traumatic hand-forearm injuries |
| assesment of the severity and painThe 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. | Other | patients with traumatic hand-forearm injuries |
Primary outcome
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).
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.
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).
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.
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).
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2023.
- BackgroundMiller RP, Kori SH, Todd DD. The Tampa Scale: a Measure of Kinisophobia. The Clinical Journal of Pain.1991;7(1).
- BackgroundLUNDBERG 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.
- Individual participant dataSharing planned: Undecided. Individual participant data is available to other researchers upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Kitiş, Professor study chair
Pamukkale University Faculty of Physiotherapy and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hand Injuries and Forearm Injuries, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05878509, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2023.