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Evaluation of Central Sensitization, Fear-Avoidance, and Pain-Pressure Threshold With Chronic Pain After Hysterectomy
Sponsor: KK Women's and Children's Hospital
Summary
Phase 1 (started in July 2019): Central Sensitization Inventory (CSI), Fear-Avoidance Components Scale (FACS), pain-pressure threshold are factors associated with chronic post-hysterectomy pain (CPHP), but a complete understanding on the development of CPHP is lacking. The study aims to identify clinically-relevant factors for CPHP that can be reliably assessed preoperatively. === Phase 2 (anticipated start May 2022): In addition to above factors, the association between heart rate variability (HRV) parameters, anxiety level, anticipated pain, and anticipated analgesia requirement with significant postoperative pain and CPHP will be investigated.
Official title: Evaluation of Central Sensitization, Fear-Avoidance, and Pain-Pressure Threshold With Chronic Pain in Post-Hysterectomy Patients: A Collaborative Cohort Study (EPOCH - Enhancing Post-operative Outcomes in Chronic Pain After Hysterectomy)
Key Details
Gender
FEMALE
Age Range
21 Years - 80 Years
Study Type
OBSERVATIONAL
Enrollment
436
Start Date
2019-07-23
Completion Date
2027-12
Last Updated
2024-11-26
Healthy Volunteers
Yes
Interventions
Pain-Pressure Threshold
Performed on bilateral trapezius muscles. Pressure will be applied at 90 degrees downward with an algometer, with the speed of pressure increase approximately 1kgf/s. Upon the sensation of pain, the patient will vocalize or raise her hand to terminate the test, and the highest reading will be recorded (up to maximum 6kgf). If two values are recorded within 0.2kgf of each other, the mean value will be recorded. If two values are greater than 0.2kgf of each other, a third test will be performed and the mean obtained.
Mechanical Temporal Summation
Pinprick hyperalgesia will be evoked using a Von Frey filament, applied to the volar aspect of the dominant forearm. Participants will report using the numerical rating scale the intensity of pain from the first stimulus. Subsequently, ten repetitive stimuli one second apart will be applied with the same filament within an area of 1cm diameter of the same forearm. Subjects will report the rate the pain intensity of the tenth stimulus. The magnitude of MTS is calculated as the difference between the last to the first pain scores. The investigators will classify the participants according to "evoked MTS" if the last stimulus is rated higher than the first, or "no MTS" if the last stimulus is rated equal or lower than the first. The research team administering the test will follow a set script.
Hospital Anxiety and Depression Scale
Standardized questionnaire to determine the level of anxiety and depression.
Pain Catastrophizing Scale
Standardized questionnaire to determine the level of pain catastrophizing.
Central Sensitization Inventory
Standardized questionnaire to determine the level of central sensitization.
Fear-Avoidance Component Score
Standardized questionnaire to determine the level of fear and avoidance.
EQ-5D
Standardized questionnaire to assess generic health-related quality of life.
heart rate variability
Heart rate variability will be determined from the R-to-R intervals obtained from a 5-minute ECG recording.
Anxiety, anticipated pain, anticipated analgesia
Preoperative anxiety (0 to 100), anticipated pain (0 to 100), and anticipated analgesia requirement (0 to 5).
State-trait anxiety inventory
Standardized questionnaire to assess anxiety.
Beck's Depression Inventory
Standardized questionnaire to assess depressive symptoms.
Locations (1)
KK Women's and Children's Hospital
Singapore, Singapore