Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Predicting Analgesic Response to Acupuncture: A Practical Approach

21. januar 2021 opdateret af: Jiang-Ti Kong, Stanford University

Predicting Analgesic Response to Acupuncture: A Randomized, Placebo-Controlled, Subject and Assessor Blinded, 100-Subject Clinical Trial of Electro-Acupuncture in the Treatment of Chronic Low Back Pain

In this placebo controlled, patient and assessor blinded clinical trial, the investigators will administer electroacupuncture vs sham electroacupuncture to patients suffering from chronic low back pain, and monitor their symptoms as well as collecting objective outcome measures. The investigators objective is to identify predictors of pain reduction and functional improvement with electroacupuncture vs placebo.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

121

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • California
      • Palo Alto, California, Forenede Stater, 94304
        • Stanford Systems Neuroscience and Pain Lab (SNAPL)

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 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Age 21-65
  2. English Fluency

  3. Chronic LBP for ≥ 6 Months

    1. Chronicity: cLBP "defined as a back pain problem that has persisted at least 3 months and has resulted in pain on at least half the days in the past 6 months."
    2. Location: "between the lower posterior margin of the rib cage and the horizontal gluteal fold
  4. Average pain over the last month ≥ 5/10

Exclusion Criteria:

  1. Radicular low back pain: defined as sharp (or burning) pain, with a defined territory, radiating down the limb, beyond the knee. Radicular pain may be accompanied by sensory and motor deficit along 1 or more dermatomes. Radicular back pain may also be accompanied by MRI evidence of intervertebral disc protrusion and compression of spinal cord and/or nerve roots.
  2. Pending litigation or Worker's compensation related to the low back pain.
  3. Currently pregnant or planning to become pregnant (in next 6 months)
  4. American Society of Anesthesiologist (ASA) class III or above physical status. ASA class III is defined as "a patient with severe systemic disease." Examples would include poorly controlled diabetes, hypertension, COPD or morbid obesity (BMI ≥ 40).
  5. Mental health conditions or treatment for mental health problems that would interfere with study procedures, at the discretion of the study team. For example, psychosis, untreated major depression, ongoing substance abuse, suicidal ideation. These will be assessed by the MINI.
  6. Medications: opioids ≥60mg morphine equivalent units/day, benzodiazepines, corticosteroids.

  7. Prohibited interventions: during the study period, the following are not permitted

    1. Back surgeries
    2. Injections with local anesthetics or steroids to the back
    3. New chiropractic maneuvers
    4. New physical therapy programs
    5. New medications for back pain
  8. Bleeding disorders at the discretion of the study team.
  9. Previous acupuncture treatment in the past 10 years.
  10. Medical conditions that would interfere with study procedures (eg. Heart disease or pacemaker, active infection), per discretion of the team

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Verum Electroacupuncture
Active Intervention
Andet: Real Acupuncture with Electrical Stimulation
Acupuncture is a therapy commonly used in East Asian countries, where the practitioner insert thin needles at specific body sites in order to relieve pain and illnesses. Recent studies found low frequency electricity applied through acupuncture needles can lead to profound pain relief by increasing endorphin levels in the central nervous system. Electroacupuncture will thus be used as the active intervention to treat chronic low back pain in this clinical study.
Andre navne:
  • Verum Electroacupuncture
  • Traditional acupuncture needles
  • ITO® ES-130® electrical stimulator
Placebo komparator: Placebo Electroacupuncture
Validated Control
Andet: Simulated Acupuncture with Electrical Stimulation
This intervention serves as the placebo control of the active intervention. Sterile acupuncture needles and the ITO electrical stimulators will be used in this intervention. But special care will be taken to have this intervention mimic the real treatment yet remaining as physiologically inert as possible.
Andre navne:
  • ITO® ES-130® electrical stimulator
  • Sham Electroacupuncture / Placebo Electroacupuncture
  • Sterile Acupuncture Needles

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean back pain intensity by patient-report
Tidsramme: 7 days
Patient self-reported mean back pain intensity on 11 point (0-10) numerical rating scale (NRS).
7 days
Roland Morris Disability Questionnaire
Tidsramme: 1 day
Validated functional outcome measure in chronic low back pain with 24 yes/no questions regarding physical function.
1 day

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quantitative Sensory Testing
Tidsramme: Tests used are typically stable for 1-2 weeks
Standardized response to noxious thermal and mechanical stimuli up to 120 seconds.
Tests used are typically stable for 1-2 weeks
Physical exam to determine neurological function
Tidsramme: 1 month
Physical exam assessing neurological function (recorded as presence or absence of light touch sensation, and stretch reflexes at the knees and ankles) in up to 5min.
1 month
Physical exam to assess lumbar facet irritation.
Tidsramme: 1 month
Physical exam assessing facet irritation via positive or negative response to lumbar facet maneuver in up to 5 minutes.
1 month
Physical exam to assess lumbar spine range of motion
Tidsramme: 1 month
Physical exam assessing range of motion in lumbar spine (measured in degrees) in up to 5 minutes.
1 month
Blood pressure
Tidsramme: 1 day
Blood pressure collected via OMRON electric blood pressure monitor, in mmHg up to 60 seconds.
1 day
Heart Rate Variability
Tidsramme: 1 month
Heart rate variability (LF/HF) collected via non-invasive, HRVLive! device up to 10 minutes.
1 month
Heart Rate Variability
Tidsramme: 1 month
Heart rate variability (BPM) collected via non-invasive, HRVLive! device up to 10 minutes.
1 month
Heart Rate Variability
Tidsramme: 1 month
Heart rate variability (ECG) collected via non-invasive, HRVLive! device up to 10 minutes.
1 month

Samarbejdspartnere og efterforskere

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

Sponsor

Stanford University

Samarbejdspartnere

National Center for Complementary and Integrative Health (NCCIH)

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

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. juli 2016

Primær færdiggørelse (Faktiske)

31. december 2018

Studieafslutning (Faktiske)

30. juni 2020

Datoer for studieregistrering

Først indsendt

15. juli 2016

Først indsendt, der opfyldte QC-kriterier

31. august 2016

Først opslået (Skøn)

7. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. januar 2021

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. januar 2021

Sidst verificeret

1. januar 2021

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 34754
  • 1K23AT008477-01A1 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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 .

Abonner