Endogenous Pain Facilitation and Inhibition in Postpartum Women

NCT ID: NCT01843517

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2017-12-05

Brief Summary

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This study seeks to further understand these three observations - (1) that the time period surrounding childbirth accelerates recovery from pain after injury (2) that this likely reflects dampened facilitating mechanisms and exaggerated inhibitory mechanisms, and (3) that stress may interfere with this protection. In this study the investigators will compare women within 2 weeks of delivery to age matched controls and anticipate that pain inhibition is increased after delivery, pain facilitation is decreased, and that there is a relationship between these pain responses and the degree of pre-existing stress.

Detailed Description

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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.

Conditions

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Pain Inhibition and Facilitation in Post Partum Women

Keywords

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Pain Facilitation Inhibition Oxytocin Postpartum

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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endogenous pain facilitation

Pain facilitation is studied by a simple test of applying over the counter capsaicin cream to the skin for only 30 min, then removing it and heating the skin to a non-noxious temperature.

No interventions assigned to this group

endogenous pain inhibition

Pain inhibition is studied by a simple test of mild pain on one area of the body reducing response to a pain stimulus in another area.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* female
* 10-14 days postpartum, term vaginal delivery
* breastfeeding (postpartum women)
* health non-pregnant female (nulliparous or at least 1 year beyond delivery)

Exclusion Criteria

* Allergy to chili peppers
* pregnant
* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James C. Eisenach, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

References

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Pan PH, Tonidandel AM, Aschenbrenner CA, Houle TT, Harris LC, Eisenach JC. Predicting acute pain after cesarean delivery using three simple questions. Anesthesiology. 2013 May;118(5):1170-9. doi: 10.1097/ALN.0b013e31828e156f.

Reference Type BACKGROUND
PMID: 23485992 (View on PubMed)

Street LM, Harris L, Curry RS, Eisenach JC. Capsaicin-induced pain and sensitisation in the postpartum period. Br J Anaesth. 2019 Jan;122(1):103-110. doi: 10.1016/j.bja.2018.09.026. Epub 2018 Nov 16.

Reference Type DERIVED
PMID: 30579387 (View on PubMed)

Other Identifiers

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IRB00022603

Identifier Type: -

Identifier Source: org_study_id