Completed

Endogenous Pain Facilitation and Inhibition in Postpartum Women

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Behavior+3

+ Neurologic Manifestations

+ Signs and Symptoms

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2013
See protocol details

Summary

Principal SponsorWake Forest University
Last updated: December 19, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

Nearly half of the world's population experiences labor and delivery processes which are associated with microscopic or gross tissue injury to the mother. Since this experience is widespread and occurs relatively early in life, the psychosocial, medical, and financial consequences of chronic pain following childbirth could be enormous. Surprisingly, previous studies with long term follow up of new mothers have included pain as a secondary measure and / or have focused on prevalence of pain without determining whether pain predated delivery or even pregnancy itself. The investigators recently performed a long term follow up study of over 1,200 women, and noted that pain which began during the childbirth itself was surprisingly rare in comparison to other physical injuries. Additionally, two central factors hypothesized to confer risk of chronic pain after other injuries including surgery, pre-dating chronic pain and degree of tissue and nerve injury, contributed minimally to the acute and sub-acute pain after childbirth. These two observations, low incidence of chronic pain and minimal effect of degree of tissue injury and history of chronic pain on sub-acute pain, point towards a potential protective effect of pregnancy or delivery on the response to physical injury.

Principal SponsorWake Forest University
Last updated: December 19, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInhibition, PsychologicalPain

Criteria

4 inclusion criteria required to participate
10-14 days postpartum, term vaginal delivery

breastfeeding (postpartum women)

female

health non-pregnant female (nulliparous or at least 1 year beyond delivery)

3 exclusion criteria prevent from participating
Allergy to chili peppers

pain medication (narcotic or non-narcotic) within 4 hours of study visit Average pain in the 24 hours preceding the study visit > 3. Postpartum women that score > 13 on the Edinburgh Postnatal Depression Scale

pregnant

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Wake Forest Baptist Medical Center

Winston-Salem, United StatesOpen Wake Forest Baptist Medical Center in Google Maps
CompletedOne Study Center