- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kadir Songür, Assoc. Prof.
- Numéro de téléphone: +905054529231
- E-mail: kadir.93@gmail.com
Lieux d'étude
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İzmir
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Cordaleo, İzmir, Turquie (Türkiye), 35570
- Izmir Democracy University
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Contact:
- Kadir Songür
- Numéro de téléphone: +905054529231
- E-mail: kadir.93@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
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.
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: CASE_ONLY
- Perspectives temporelles: CROSS_SECTIONAL
Cohortes et interventions
Groupe / Cohorte |
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Group 1
complex regional pain syndrome |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Construct Validity of the Turkish Revised Bath Complex Regional Pain Syndrome Body Perception Disturbance Scale
Délai: 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
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Tampa Scale for Kinesiophobia
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026/27
Plan pour les données individuelles des participants (IPD)
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Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
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