Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 10 of 11 for:    pelvic pain AND NICHD

Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04685343
Recruitment Status : Recruiting
First Posted : December 28, 2020
Last Update Posted : June 10, 2021
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Laura Payne, Mclean Hospital

Brief Summary:
The study will use primary dysmenorrhea (PD; menstrual pain without an identified organic cause) as a model to examine biomarkers associated with menstrual and non-menstrual bodily pain in adolescent girls, ages 14-18. Participants will undergo extensive phenotyping including pain inhibition testing and multimodal neuroimaging to obtain indices brain structure and function at baseline and 12 months later. Menstrual pain severity and non-menstrual bodily pain will be assessed monthly for 24 months. Aims of the study are: 1) to identify the central mechanisms of PD using measures of pain inhibition and brain structure and connectivity of sensorimotor, default, emotional arousal, and salience networks, 2) to determine deficits in pain inhibition and alterations in brain structure and network connectivity that predict the one-year developmental trajectories of menstrual pain and non-menstrual bodily pain, and 3) to identify the dynamic relationship between alterations in pain inhibition and brain structure and connectivity with symptom change in menstrual pain and non-menstrual bodily pain. We hypothesize that deficits in endogenous pain inhibition and alterations in brain structure, connectivity, and function of regional networks will be positively associated with menstrual pain severity ratings at baseline and predict the trajectory of menstrual and non-menstrual bodily pain over 2 years. The results are expected to identify specific mechanisms and characteristics that predict the transition from acute/cyclical pain to persistent or chronic pain, which will support the development of therapies to prevent the transition from recurrent to chronic pain in adulthood.

Condition or disease Intervention/treatment Phase
Primary Dysmenorrhea Behavioral: Quantitative Sensory Testing Other: fMRI Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 212 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Behavioral and Neural Phenotypes of Primary Dysmenorrhea in Adolescents
Actual Study Start Date : December 14, 2020
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arm Intervention/treatment
Experimental: fMRI and laboratory pain induction Behavioral: Quantitative Sensory Testing
Quantitative sensory testing (QST) consisting of 4 pain induction and sensory sensitivity tasks (i.e., pressure applied to the thumbnail, arms, shoulders, and lower abdomen, a cold water task, and one video-watching task).

Other: fMRI
Functional magnetic resonance imaging (fMRI) session consisting of structural and functional brain scans.




Primary Outcome Measures :
  1. Menstrual pain [ Time Frame: Baseline ]
    Rating of average pain during the first two days of the most recent menstrual period on a 0 (no pain) to 10 (worst pain possible) numeric rating scale.

  2. Change in menstrual pain from baseline to 12-months post baseline [ Time Frame: At baseline and 12 months after baseline ]
    Change in the rating of average pain during the first two days of the most recent menstrual period on a 0 (no pain) to 10 (worst pain possible) numeric rating scale.

  3. Change in bodily pain from baseline to 12-months post baseline [ Time Frame: At baseline and 12 months after baseline ]
    Change in the number of bodily locations endorsed as painful during the prior month.

  4. Pressure pain sensitivity (PPS) [ Time Frame: At baseline ]
    The pain rating [on a 0 (no pain) to 100 (worst pain possible) numeric rating scale] of a 5-second, 2.0 kg/cm2 application of pressure to the right thumbnail bed.

  5. Pressure pain tolerance (PPT) [ Time Frame: At baseline ]
    The last rated pressure delivered in a series of increasing pressure applications to the right thumbnail bed. Each application of pressure lasts for 5 seconds. The pressure sequence is terminated when the participant reaches their individual tolerance and decides to stop, when the participant reaches the safety maximum amount of pressure, or when the participant rates the pressure >=80 on a 0 (no pain) to 100 (worst pain possible) numeric rating scale.

  6. Trapezius pressure pain threshold (TPPTh) [ Time Frame: At baseline ]
    The amount of pressure, applied by a pressure algometer to the participant's trapezius muscle, needed for the pressure stimulus to first feel painful to the participant.

  7. Conditioned pain modulation (CPM) [ Time Frame: At baseline ]
    Conditioned pain modulation (CPM) assesses pain inhibition. CPM is calculated as the change in the TPPTh between when the pressure is applied by itself (test stimulus) and when it is applied while the participant's hand is submerged in cold water (conditioning stimulus).

  8. Gray matter volume [ Time Frame: At baseline ]
    Gray matter regional volume and surface area will be measured from images obtained during the fMRI session.

  9. White matter fiber tract values [ Time Frame: At baseline ]
    Obtained from fiber tracking using images obtained during diffusion tensor imaging (DTI). Values represent anatomical connectivity of cortical and subcortical brain regions.

  10. Resting state networks [ Time Frame: At baseline ]
    Calculated from images obtained during resting state fMRI. Region-to-region connectivity indices are obtained by correlating fMRI time series corrected for physiological noise and motion. Region-to-region connectivity strength of the regions of interest (i.e., salience, sensorimotor, emotional arousal, and default mode networks) will be assessed for each participant.


Secondary Outcome Measures :
  1. Change in menstrual pain from 12-months post baseline to 24-months post baseline [ Time Frame: 12 months after baseline and 24 months after baseline ]
    Change in the rating of average pain during the first two days of the most recent menstrual period on a 0 (no pain) to 10 (worst pain possible) numeric rating scale.

  2. Change in bodily pain from 12-months post baseline to 24-months post baseline [ Time Frame: 12 months after baseline and 24 months after baseline ]
    Change in the number of bodily locations endorsed as painful during the prior month.

  3. Salivary pro-inflammatory cytokines [ Time Frame: Three time points during each of two study visits: during questionnaire completion (approx. 20 min. after arrival), immediately after the imaging session (approx. 90 min. after arrival), and following the final pain task (approx. 120 min after arrival) ]
    Assessment of pro-inflammatory cytokines found in the saliva (e.g., IL-1 Beta, IL-6, IL-8, TNF-Alpha)

  4. Trapezius pressure pain threshold (TPPTh) [ Time Frame: 12 months after baseline ]
    The amount of pressure, applied by a pressure algometer to the participant's trapezius muscle, needed for the pressure stimulus to first feel painful to the participant.

  5. Change in conditioned pain modulation (CPM) from baseline to 12-months post baseline [ Time Frame: At baseline and 12 months after baseline ]
    Alterations in pain inhibition will be assessed via the direction of the change (i.e., improvement in pain inhibition, worsening of pain inhibition, and stable pain inhibition) as well as the magnitude of the change.

  6. Change in pressure pain sensitivity (PPS) from baseline to 12-months post baseline [ Time Frame: At baseline and 12 months after baseline ]
    Change in the pain rating [on a 0 (no pain) to 100 (worst pain possible) numeric rating scale] of a 5-second, 2.0 kg/cm2 application of pressure to the right thumbnail bed.

  7. Change in pressure pain tolerance (PPT) from baseline to 12-months post baseline [ Time Frame: At baseline and 12 months after baseline ]
    Change in the PPT described above between baseline and 12-months post baseline.

  8. Change in gray matter volume from baseline to 12-months post baseline [ Time Frame: At baseline and 12 months after baseline ]
    Change in the gray matter regional volume and surface area obtained from images obtained during the fMRI session.

  9. Change in white matter fiber tract values from baseline to 12-months post baseline [ Time Frame: At baseline and 12 months after baseline ]
    Change in the DTI-produced fiber tracking values, which represent anatomical connectivity of cortical and subcortical brain regions.

  10. Change in resting state networks [ Time Frame: At baseline and 12 months after baseline ]
    Change in region-to-region connectivity strength of the regions of interest (i.e., salience, sensorimotor, emotional arousal, and default mode networks).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   14 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Female aged 14-18 years
  2. Self-reported menstrual cycle averaging 22-35 days
  3. Access to a smartphone or email
  4. Right handed
  5. Body Mass Index (BMI) of 35 or less
  6. Able to read and understand English
  7. Ability and willingness to provide written informed assent/consent
  8. Availability of a parent to provide written parental permission (for participants under age 18)

Exclusion Criteria:

  1. Use of oral contraceptives or any exogenous hormones in the previous 3 months prior to participation
  2. Presence of factors indicative of secondary dysmenorrhea (e.g., self-reported presence of persistent pelvic pain throughout the month)
  3. Diagnosis of chronic pain condition (e.g., Irritable bowel syndrome (IBS), functional abdominal pain, interstitial cystitis/painful bladder syndrome)
  4. Current self-reported severe depression, bipolar disorder, panic disorder, or ADHD, or current treatment for these conditions
  5. Diagnosis of an eating disorder within the last 6 months
  6. Current or past diagnosis of any psychotic disorder
  7. Currently pregnant
  8. Self-reported weekly use of alcohol, cannabis, and/or other illegal substances
  9. Use of stimulants (including methamphetamine and/or medications for the treatment of ADHD) or opioids in the previous 3 months. Participants who use other analgesics will be included but will be requested to not take these analgesics within the previous 24 hours of the laboratory session
  10. History of pelvic inflammatory disease or sexually transmitted disease
  11. Acute illness or injury that would potentially impact pain task performance (e.g., fever, flu symptoms) or that affect sensitivity of the extremities (e.g., Reynaud's disease). Potential participants who are being treated for cardiovascular disease(s) will be included pending discussion with the participant's primary physician
  12. Developmental delay, diagnosis of autism, or significant cognitive impairment that may preclude understanding of study procedures
  13. Presence of any ferromagnetic appliance or implants (braces, retainers, spacers, wires, screws, etc.) in the mouth or any other body part, which is a contraindication for the magnetic resonance imaging (MRI) scanner
  14. Significant fear of enclosed places (claustrophobia)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04685343


Contacts
Layout table for location contacts
Contact: Laura Seidman (617) 855-2746 LCSeidman@mclean.harvard.edu

Locations
Layout table for location information
United States, Massachusetts
McLean Hospital Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Laura Seidman    617-855-2746    LCSeidman@mclean.harvard.edu   
Sponsors and Collaborators
Mclean Hospital
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Layout table for investigator information
Principal Investigator: Laura Payne, PhD Mclean Hospital
Layout table for additonal information
Responsible Party: Laura Payne, Assistant Professor, Mclean Hospital
ClinicalTrials.gov Identifier: NCT04685343    
Other Study ID Numbers: 2019P001729
R01HD093680 ( U.S. NIH Grant/Contract )
First Posted: December 28, 2020    Key Record Dates
Last Update Posted: June 10, 2021
Last Verified: June 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations