- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01843517
Endogenous Pain Facilitation and Inhibition in Postpartum Women
December 15, 2017 updated by: Wake Forest University
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.
Study Overview
Status
Completed
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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North Carolina
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Winston-Salem, North Carolina, United States, 27157
- Wake Forest Baptist Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Healthy women 10-14 days postpartum following term vaginal delivery, who are breast feeding and age- and race- matched healthy, nonpregnant women, either nulliparous or at least 1 year beyond delivery.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Area of hyperalgesia will be the primary outcome measure
Time Frame: 40 minutes post capsaicin application
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Hyperalgesia and allodynia on the skin of the forearm will be established by heating the forearm with a 4 cm2 Peltier controlled thermode (TSA®) to 45 degrees Celsius for 5 minutes.
The investigators will then apply topical capsaicin (0.075% cream, Bioglan Pharmaceuticals) under an occlusive dressing at the same site as the thermal probe for 30 minutes.
40 minutes after removal of the capsaicin cream the site will be heated to 40 degrees Celsius for 5 minutes (rekindling) following the end of capsaicin application.
The investigators will test skin sensations with the filament and cotton wisp after this heating.
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40 minutes post capsaicin application
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Percent reduction in degree of pain to the 49 degrees Celsius stimulus during the time the foot is immersed in the cold water
Time Frame: 15 minutes
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Conditioned pain modulation will be induced by placing a foot in a container of circulating water maintained at 10 degrees Celsius for 90 seconds.
Thirty seconds after the foot is placed into container of circulating water, the stimulus response to heat on the contralateral forearm will be measured using a 49 degrees Celsius stimulus for 5 seconds.
The foot will then be withdrawn and warmed with warm blankets.
The stimulus response to heat stimuli on the arm will be measured 5 and 15 min thereafter.
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15 minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James C. Eisenach, MD, Wake Forest University Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
December 5, 2017
Study Completion (Actual)
December 5, 2017
Study Registration Dates
First Submitted
April 25, 2013
First Submitted That Met QC Criteria
April 25, 2013
First Posted (Estimate)
April 30, 2013
Study Record Updates
Last Update Posted (Actual)
December 19, 2017
Last Update Submitted That Met QC Criteria
December 15, 2017
Last Verified
December 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00022603
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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