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Brain Response to Pain Control in People With Chronic Pain

Mechanisms of Pain Control in Chronic Pain Patients

Background:

- Researchers want to look at how the brain responds to painful stimulations. They also want to see if these responses are different in people with and without chronic pain. To test the brain s response, they will use a chemical called naloxone. Naloxone is used to treat overdoses of painkilling drugs like morphine. It may be able to block the effect of a pain-relieving cream. Researchers will apply a pain-relieving cream to a person s lower leg and look at the results of sensitivity tests with either naloxone or a placebo. This study will compare the results from people with chronic pain (like fibromyalgia) to those of people without chronic pain.

Objectives:

- To look at the brain s response to pain in people with and without chronic pain.

Eligibility:

  • Individuals at least 18 years of age who have fibromyalgia.
  • Healthy volunteers at least 18 years of age.

Design:

  • This study will involve a screening visit and two testing visits. The testing visits will be about a week apart.
  • Participants will be screened with a physical exam and medical history. Blood and urine samples will be collected. After the screening participants will be administered several questionnaires about their personality, and their thoughts and feelings.
  • At the first visit, participants will try out the magnetic resonance imaging (MRI) scan before using it at the next visit. They will then have the painkilling cream applied on one part of their lower leg and a normal moisturizing cream on the other part of their lower leg. They will have heat pulses on these skin areas and rate the pain.
  • At the second visit, participants will have tests in the MRI scanner. The heat pulse tests will be repeated after an infusion of either naloxone or a placebo.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

Different pain reducing drugs work in different ways to reduce pain. Many drugs, including morphine and codeine, reduce pain by binding to opiate receptors in the brain. Another chemical, naloxone, can block the effect of these drugs. In this study, we are looking at brain responses to a pain-relieving cream and whether naloxone blocks the effect of the cream. We will compare the results of people with chronic pain (fibromyalgia) to those of people without chronic pain.

Design:

The study compares MRI response to painful stimulation between people with fibromyalgia and healthy volunteers under two conditions: 1) naloxone, 2) placebo.

Outcome measures: Pain ratings and pain-related MRI responses are compared between people with fibromyalgia and healthy volunteers

Studietyp

Observationell

Inskrivning (Faktisk)

92

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

    • Maryland
      • Bethesda, Maryland, Förenta staterna, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

  • INCLUSION CRITERIA:

Inclusion Criteria for Patients:

  1. Patient must be greater than or equal to 18 years of age.
  2. Patient must be able to comprehend English.
  3. Patient must be able to provide written informed consent.
  4. Patient must have had chronic widespread pain for at least one year prior to participation with an average daily intensity at least 4 out of 10.

Inclusion Criteria for Healthy Controls:

  1. Healthy control must be greater than or equal to 18 years of age
  2. Healthy control must be able to comprehend English.
  3. Healthy control must be able to provide written informed consent.

EXCLUSION CRITERIA:

Exclusion criteria for patients:

  1. Patient is unable to comply with study procedures or follow-up visits
  2. Patient smokes more than 10 cigarettes of nicotine per week.
  3. Patient uses recreational drugs.
  4. Female patient consumes more than 7 half-pint beers, 7 6-oz glasses of wine or 7 1-oz shots of spirits (or equivalent) per week, and male patient consumes 14 such drinks per week. Further, patient consumes more than 5 drinks at one time.
  5. Patient is pregnant or breastfeeding.
  6. Patient has a major medical condition, such as kidney, liver, cardiovascular, neurological or current psychiatric condition.
  7. Patient has currently or has had in the past major depression, bipolar disorder, psychosis or suicide attempts.
  8. Patient has metal in his/her body which would make having an MRI scan unsafe, such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments, permanent eye liner or small metal fragments in the eye that welders and other metal workers may have.
  9. Patient is uncomfortable in small closed spaces (has claustrophobia) so that he/she would feel uncomfortable in the MRI machine.
  10. Patient cannot lie comfortably flat on his/her back for up to 75 minutes in the MRI scanner.
  11. Patient has allergies to topical treatment.
  12. Patient has a chronic pain condition other than FM.
  13. Patient has taken within the last two weeks opioids. Other medications used to treat fibromyalgia at the standard doses in the community can be taken. We will not ask participants to stop any medication to participate in the study.
  14. Patient has previously taken opioids for more than one month on a continual basis, within the last 6 months.
  15. Patient had seen study information on clinicaltrials.gov prior to September 23, 2013.
  16. Patients who decline to be audio and/or videotaped will be excluded from the qualitative interview component of the study.

Exclusion criteria for healthy controls:

  1. Healthy control is unable to comply with study procedures or follow-up visits
  2. Healthy control smokes more than 10 cigarettes of nicotine per week.
  3. Healthy control uses recreational drugs.
  4. Female healthy control consumes more than 7 half-pint beers, 7 6-oz glasses of wine or 7 1-oz shots of spirits (or equivalent) per week, and male healthy control consumes 14 such drinks per week. Further, healthy control consumes more than 5 drinks at one time.
  5. Healthy control is pregnant or breastfeeding.
  6. Healthy control has a major medical condition, such as kidney, liver, cardiovascular, neurological or current psychiatric condition.
  7. Healthy control has currently or has had in the past major depression, bipolar disorder, psychosis or suicide attempts.
  8. Healthy control has metal in his/her body which would make having an MRI scan unsafe, such as pacemakers, medication pumps, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves or cochlear implants), shrapnel fragments,

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Vad mäter studien?

Primära resultatmått

Resultatmått
Tidsram
Pain Perception
Tidsram: 3 years
3 years

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Mary C Bushnell, Ph.D., National Center for Complementary and Integrative Health (NCCIH)

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

28 maj 2013

Primärt slutförande (Faktisk)

8 september 2016

Avslutad studie (Faktisk)

8 september 2016

Studieregistreringsdatum

Först inskickad

12 juni 2013

Först inskickad som uppfyllde QC-kriterierna

12 juni 2013

Första postat (Uppskatta)

14 juni 2013

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 december 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

6 december 2019

Senast verifierad

8 september 2016

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 130143
  • 13-AT-0143

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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