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Opioid Treatment for Chronic Low Back Pain and the Impact of Mood Symptoms

14. juni 2017 opdateret af: Ajay D. Wasan,M.D.,M.Sc., Brigham and Women's Hospital
Opioids are frequently prescribed for chronic low back pain (CLBP). Psychiatric illness, such as high levels of depression and anxiety symptoms, is a common co-occurrence in chronic pain patients (and is termed comorbid negative affect [NA]). The purpose of the study is to determine whether CLBP patients with either a high vs. a low or moderate degree of NA have different pain relief responses to oral opioids.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The level of high, moderate or low NA was determined based on the participant's score on the Hospital Anxiety and Depression Scale (HADS). The HADS is a self-reported questionnaire that has 14 questions related to 2 domains: Anxiety subscale (7 questions) and Depression subscale (7 questions). Each item on the questionnaire is scored from 0 (least amount of anxiety/depression) to 3 (greatest amount of anxiety/depression), with total score between 0 and 21 for either anxiety or depression. Participants were assigned to high, moderate or low NA groups using the following HADS score criteria:

  • High NA = HADS score ≥9 on each subscale
  • Moderate NA = HADS score ≥6 to ≤8 on each subscale
  • Low NA = HADS score ≤5 on each subscale

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

81

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Massachusetts
      • Chestnut Hill, Massachusetts, Forenede Stater, 02467
        • Brigham and Women's Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

21 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Low Back Pain > 3/10
  • Pain > 1 year
  • Degenerative disc disease as seen on magnetic resonance imaging (MRI), which must meet minimum disc grading criteria: at least a grade III disc degeneration, a hyperintense zone, or abnormal disc morphology.
  • Patients who may have had back surgery will be included.
  • No epidural steroids or other nerve blocks for back pain either two weeks before or during the study period.
  • No opioids or on short-acting opioids only (max. daily amount=120 mg morphine equivalents). It is not feasible to recruit only opioid naive patients.
  • Must agree to 2-week washout for those on opioids.
  • No active substance abuse.
  • No intention to take new pain or psychiatric treatments during the study, including chiropractic, physical therapy, or complementary or alternative treatments (CAM). It is not feasible to take participants off of any other pain medications, such as nonsteroidal anti-inflammatory drugs (NSAIDS).
  • No pregnancy or the intent to become pregnant during the study, and no nursing mothers.
  • Women, who are able to bear children, must agree to use contraceptives throughout the study.
  • In men, normal baseline testosterone levels.

Exclusion Criteria:

  • Patients with pain due to disorders not including a component of disc degeneration, or those with unknown causes of pain will be excluded.
  • Patients with the intent to undergo back surgery will be excluded.
  • Patients with a history of recent or ongoing alcohol or other drug addiction disorders will be excluded.
  • Patients with any history of substance abuse of opioids will be excluded.
  • Patients whose diagnosis cannot be firmly established according to criteria described above would not be included.
  • Patients whose medical and psychiatric comorbidities are not well controlled, or who are currently experiencing an acute exacerbation of the medical comorbidity, will be excluded.
  • Males with abnormal testosterone levels will be excluded (normal range is 1800-6650 pg/ml).
  • Female patients who nursing will be excluded.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Low Negative Affect (NA)
Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
Medicin: Oxycodone
Daily dosage up to 120 mg
Medicin: Morphine
Daily dosage up to 90 mg immediate release or 180 mg extended release
Andre navne:
  • Morphine sulfate (MS) Contin
  • Morphine sulfate instant release (MSIR)
  • Morphine sulfate extended release (MSER)
Medicin: Placebo
Placebo-matching oxycodone, placebo-matching morphine
Aktiv komparator: Moderate NA
Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
Medicin: Oxycodone
Daily dosage up to 120 mg
Medicin: Morphine
Daily dosage up to 90 mg immediate release or 180 mg extended release
Andre navne:
  • Morphine sulfate (MS) Contin
  • Morphine sulfate instant release (MSIR)
  • Morphine sulfate extended release (MSER)
Medicin: Placebo
Placebo-matching oxycodone, placebo-matching morphine
Aktiv komparator: High NA
Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
Medicin: Oxycodone
Daily dosage up to 120 mg
Medicin: Morphine
Daily dosage up to 90 mg immediate release or 180 mg extended release
Andre navne:
  • Morphine sulfate (MS) Contin
  • Morphine sulfate instant release (MSIR)
  • Morphine sulfate extended release (MSER)
Medicin: Placebo
Placebo-matching oxycodone, placebo-matching morphine

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent Change in Average Daily Pain Score
Tidsramme: Baseline and Week 20
Participants rated their average lower back pain over the past 24 hours using an 11-point scale (0=no pain to 10=worst possible pain) and recorded it in an electronic diary. The percent change in pain score from baseline is calculated using weekly averages for up to 20 weeks. Linear mixed modeling (LMM) analysis was used to allow for inclusion in the analysis of the majority of participants with any missing data. For the LMM model, group, group × week, average baseline pain, and opioid use at baseline (yes/no) were entered as fixed effects using an autoregressive covariance structure. Participant, intercept, and week were entered as random effects, using a compound symmetry covariance structure. A positive change from baseline indicates an improvement.
Baseline and Week 20

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Brigham and Women's Hospital

Samarbejdspartnere

National Institute on Drug Abuse (NIDA)
Arthritis Foundation

Efterforskere

  • Ledende efterforsker: Ajay D Wasan, MD, MSc, Brigham and Women's Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. februar 2009

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først indsendt

28. december 2011

Først indsendt, der opfyldte QC-kriterier

29. december 2011

Først opslået (Skøn)

2. januar 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2007P-001047
  • 5K23DA020681-05 (U.S. NIH-bevilling/kontrakt)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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