Evaluation of Central Sensitization, Fear-Avoidance, and Pain-Pressure Threshold With Chronic Pain After Hysterectomy

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.

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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.

Conditions

• Hysterectomy
• Chronic Pain
• Central Sensitisation
• Anxiety Depression

Interventions

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

Hospital Anxiety and Depression Scale

Standardized questionnaire to determine the level of anxiety and depression.

DIAGNOSTIC_TEST

Pain Catastrophizing Scale

Standardized questionnaire to determine the level of pain catastrophizing.

DIAGNOSTIC_TEST

Central Sensitization Inventory

Standardized questionnaire to determine the level of central sensitization.

DIAGNOSTIC_TEST

Fear-Avoidance Component Score

Standardized questionnaire to determine the level of fear and avoidance.

DIAGNOSTIC_TEST

EQ-5D

Standardized questionnaire to assess generic health-related quality of life.

DIAGNOSTIC_TEST

heart rate variability

Heart rate variability will be determined from the R-to-R intervals obtained from a 5-minute ECG recording.

DIAGNOSTIC_TEST

Anxiety, anticipated pain, anticipated analgesia

Preoperative anxiety (0 to 100), anticipated pain (0 to 100), and anticipated analgesia requirement (0 to 5).

DIAGNOSTIC_TEST

State-trait anxiety inventory

Standardized questionnaire to assess anxiety.

DIAGNOSTIC_TEST

Beck's Depression Inventory

Standardized questionnaire to assess depressive symptoms.

Sponsors & Collaborators

• KK Women's and Children's Hospital

  lead OTHER_GOV

Principal Investigators

• Farida Ithnin, MBBS · KK Women's and Children's Hospital

Eligibility

Min Age

21 Years

Max Age

80 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-07-23

Primary Completion

2025-12-31

Completion

2027-12-31

Countries

• Singapore

Study Locations