Validity and Reliability of the Turkish Version of the Revised Bath CRPS Body Perception Disturbance Scale

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIzmir Democracy University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

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.

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

42 Participants
are grouped into 1 trial group
Group A: Group 1

Trial outcomes

Primary outcomes

1

Construct Validity of the Turkish Revised Bath Complex Regional Pain Syndrome Body Perception Disturbance Scale

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.

Time frame
Day 1
2

Internal Consistency of the Turkish r-B-CRPS-BPDS

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.

Time frame
Day 1
3

Test-Retest Reliability of the Turkish r-B-CRPS-BPDS

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).

Time frame
Baseline and 7-10 days after baseline

Secondary outcomes

1

Tampa Scale for Kinesiophobia

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.

Time frame
Day 1
2

EQ-5D-5L

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.

Time frame
Day 1
3

Numeric Rating Scale for Pain

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.

Time frame
Day 1
4

Complex Regional Pain Syndrome Severity Score

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.

Time frame
Day 1

Other outcomes

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