- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07858812
Validity and Reliability of the Turkish Version of the Revised Bath CRPS Body Perception Disturbance Scale
Cross-Cultural Adaptation and Evaluation of the Validity and Reliability of the Turkish Version of the Revised Bath CRPS Body Perception Disturbance Scale
This study aims to perform the cross-cultural adaptation of the Revised Bath Complex Regional Pain Syndrome Body Perception Disturbance Scale (r-B-CRPS-BPDS) into Turkish and to evaluate the validity and reliability of the Turkish version in adults with Complex Regional Pain Syndrome (CRPS). Adult participants diagnosed with CRPS according to the Budapest clinical diagnostic criteria will be included. Participants will complete the Turkish r-B-CRPS-BPDS together with measures of kinesiophobia, health-related quality of life, and pain intensity. CRPS clinical severity will also be assessed. Construct validity, internal consistency, test-retest reliability, measurement error, and floor and ceiling effects of the Turkish r-B-CRPS-BPDS will be evaluated. For test-retest reliability, clinically stable participants will complete the r-B-CRPS-BPDS again after 7-10 days. The study is intended to provide a culturally adapted, valid, and reliable Turkish version of the r-B-CRPS-BPDS for assessing body perception disturbance in individuals with CRPS.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Kadir Songür, Assoc. Prof.
- Telefonní číslo: +905054529231
- E-mail: kadir.93@gmail.com
Studijní místa
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İzmir
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Cordaleo, İzmir, Turecko (Türkiye), 35570
- Izmir Democracy University
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Kontakt:
- Kadir Songür
- Telefonní číslo: +905054529231
- E-mail: kadir.93@gmail.com
-
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
This study will include patients aged 18 years and older who have been diagnosed with complex regional pain syndrome based on Budapest clinical diagnosis criteria and who have applied to the Physical Medicine and Rehabilitation Outpatient Clinic at İzmir Democracy University Buca Seyfi Demirsoy Education and Research Hospital.
Popis
Inclusion Criteria:
- Meet the criteria for a diagnosis of CRPS based on the Budapest clinical diagnostic criteria following clinical evaluation
- Have complex regional pain syndrome affecting the upper or lower extremity
- Be able to provide written informed consent to participate in the study
- Have the cognitive ability to understand the forms and scales in Turkish
Exclusion Criteria:
- The presence of cognitive impairment or communication difficulties severe enough to prevent understanding of the scales or providing reliable responses
- The presence of a central neurological disorder that could significantly affect body perception, somatosensory function, or limb function (e.g., stroke, multiple sclerosis, spinal cord injury)
- The presence of a serious additional neurological or musculoskeletal disorder in the evaluated extremity, other than CRPS, that could significantly affect body perception and function
- The presence of a severe psychiatric disorder severe enough to prevent reliable clinical evaluation and administration of the scales
- Inability to complete the scales or demonstrate sufficient cooperation during the data collection process.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: CASE_ONLY
- Časové perspektivy: CROSS_SECTIONAL
Kohorty a intervence
Skupina / kohorta |
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Group 1
complex regional pain syndrome |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Construct Validity of the Turkish Revised Bath Complex Regional Pain Syndrome Body Perception Disturbance Scale
Časové okno: Day 1
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The construct validity of the Turkish version of the Revised Bath Complex Regional Pain Syndrome Body Perception Disturbance Scale (r-B-CRPS-BPDS) will be evaluated in adults with Complex Regional Pain Syndrome. The r-B-CRPS-BPDS assesses disturbances in body perception related to the affected limb, including feelings of ownership, awareness of limb position, emotional feelings toward the limb, perceived differences in size, temperature, pressure, and weight, desire for amputation, and mental representation of the affected limb. The total score ranges from 0 to 47, with higher scores indicating greater body perception disturbance. Construct validity will primarily be examined by assessing the association between the r-B-CRPS-BPDS total score and the Tampa Scale for Kinesiophobia total score. Associations with pain intensity, health-related quality of life, and clinical CRPS severity will also be examined. |
Day 1
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Internal Consistency of the Turkish r-B-CRPS-BPDS
Časové okno: Day 1
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The internal consistency of the Turkish r-B-CRPS-BPDS will be evaluated using Cronbach's alpha coefficient and corrected item-total correlations. The analysis will determine the degree to which the items of the Turkish version consistently assess the construct of body perception disturbance in individuals with Complex Regional Pain Syndrome. |
Day 1
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Test-Retest Reliability of the Turkish r-B-CRPS-BPDS
Časové okno: Baseline and 7-10 days after baseline
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Test-retest reliability will be evaluated in clinically stable participants by administering the Turkish r-B-CRPS-BPDS twice, with an interval of 7-10 days. Reliability will be assessed using the intraclass correlation coefficient (ICC), based on a two-way random-effects model, single measurement, and absolute agreement [ICC(2,1)]. Measurement error will additionally be evaluated using the standard error of measurement (SEM) and smallest detectable change (SDC). |
Baseline and 7-10 days after baseline
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Tampa Scale for Kinesiophobia
Časové okno: Day 1
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The Tampa Scale for Kinesiophobia (TSK) is a 17-item self-report questionnaire used to assess fear of movement and reinjury. Each item is rated on a 4-point Likert scale. Higher total scores indicate greater levels of kinesiophobia. The Turkish version of the scale has demonstrated validity and reliability. The TSK total score will be used primarily to examine the construct validity of the Turkish r-B-CRPS-BPDS. |
Day 1
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EQ-5D-5L
Časové okno: Day 1
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The EQ-5D-5L will be used to assess health-related quality of life. It evaluates five dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with five response levels for each dimension. Participants will also rate their current overall health using the EQ Visual Analogue Scale (EQ VAS), ranging from 0 to 100, with higher scores representing better self-rated health. EQ-5D-5L outcomes will be examined in relation to body perception disturbance. |
Day 1
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Numeric Rating Scale for Pain
Časové okno: Day 1
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Pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS) ranging from 0 to 10. A score of 0 represents no pain, whereas a score of 10 represents the worst imaginable pain. Higher scores indicate greater pain intensity. The NRS score will be examined in relation to the r-B-CRPS-BPDS total score. |
Day 1
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Complex Regional Pain Syndrome Severity Score
Časové okno: Day 1
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Clinical severity of Complex Regional Pain Syndrome will be assessed using the Complex Regional Pain Syndrome Severity Score (CSS). The 17-item score incorporates patient-reported symptoms and signs identified during clinical examination across sensory, vasomotor, sudomotor/edema, motor, and trophic domains. Each item is scored as absent or present, producing a total score ranging from 0 to 17. Higher scores indicate greater clinical severity of Complex Regional Pain Syndrome. |
Day 1
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026/27
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Individual participant data (IPD) will not be shared because the data contain potentially identifiable sensitive clinical information, and sharing was not covered in the original informed consent provided to participants. Additionally, institutional and national data protection regulations limit the transfer of raw, de-identified individual-level data outside the research team.
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