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Pilot Study - Impact of Traditional Acupuncture on Menopause

8. april 2019 oppdatert av: Noel Bairey Merz, Cedars-Sinai Medical Center

Pilot Study - The Impact of Traditional Acupuncture on Menopausal Vasomotor Symptoms, Psychological Stress and the Hypothalamic Pituitary Adrenal (HPA) - Sympathetic Nervous System (SNS) Axis: A Randomized, Controlled Trial

This pilot project is a randomized research study to examine the effects of acupuncture on menopausal symptoms. The investigators will recruit up to 45 Cedars employees (excluding Dr Bairey Merz's employees) with menopausal symptoms by posting a study flyer on Exchange. If a patient is interested in this study, she may contact the research team for further information. Once a patient is identified as being eligible for the study, she will be contacted to schedule the screening visit. They will receive an explanation of the study. They will be sent the consent form to review prior to the initial visit. At the initial visit, prior to any study-related procedures, the consent will be reviewed with the patient. After all questions have been answered and the patient appears to fully understand the study, the patient will be asked to provide written consent.

This pilot project will collect data from three study groups as stated in the NIH application proposal. The first research study group will undergo traditional acupuncture (TA). The second research study group will receive alternative acupuncture (AA). The third group will be a waiting control group (WC) that will receive four weeks of acupuncture following completion of the study duration.

Traditional acupuncture means that the needle is inserted in true acupuncture point locations. Alternative acupuncture is a technique that varies slightly from traditional acupuncture and is used to assess which technique, if any, produces the best therapeutic results. Waiting control is a group of subjects who get neither traditional nor alternative acupuncture during the duration of treatment, which in this case, is 3 months.

Patients will be randomized into one of the three study groups, and will have one in three chance of being placed in one of the three groups. Neither patients nor the investigators can choose which group patients are assigned to. Patients from TA and AA groups will be asked to come to Cedars-Sinai a total of 39 times (36 sessions and 3 clinic visits) over a three-four month period. It will compare the effects (good or bad) of traditional acupuncture (TA) with alternative acupuncture (AA) on the menopausal symptoms to be studied in this research. Patients from WC group will be asked to come to Cedars-Siani a total of 15 times. Other study procedures include physical exam, blood and urine collection for hormone tests, questionnaire interview, etc.

During the pilot phase of this study subjects will record the number of mild, moderate, severe and/or very severe hot flashes that occur each day in a hot flash diary. There is also an option for patients to record other symptoms they may experience during that week other then hot flashes as well as a place for additional comments. Subjects will complete the diary for seven consecutive days. It is a simple form that takes very little time to complete each day (only 5-10 minutes) and will not impact the duration of the study participation.

No genetic study will be conducted in this pilot project.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

This pilot project is a randomized research study to examine the effects of acupuncture on menopausal symptoms. The investigators will recruit up to 45 Cedars employees (excluding Dr Bairey Merz's employees) with menopausal symptoms by posting a study flyer on Exchange. If a patient is interested in this study, she may contact the research team for further information. Once a patient is identified as being eligible for the study, she will be contacted to schedule the screening visit. They will receive an explanation of the study. They will be sent the consent form to review prior to the initial visit. At the initial visit, prior to any study-related procedures, the consent will be reviewed with the patient. After all questions have been answered and the patient appears to fully understand the study, the patient will be asked to provide written consent.

This pilot project will collect data from three study groups as stated in the NIH application proposal. The first research study group will undergo traditional acupuncture (TA). The second research study group will receive alternative acupuncture (AA). The third group will be a waiting control group (WC) that will receive four weeks of acupuncture following completion of the study duration.

Traditional acupuncture means that the needle is inserted in true acupuncture point locations. Alternative acupuncture is a technique that varies slightly from traditional acupuncture and is used to assess which technique, if any, produces the best therapeutic results. Waiting control is a group of subjects who get neither traditional nor alternative acupuncture during the duration of treatment, which in this case, is 3 months.

Patients will be randomized into one of the three study groups, and will have one in three chance of being placed in one of the three groups. Neither patients nor the investigators can choose which group patients are assigned to. Patients from TA and AA groups will be asked to come to Cedars-Sinai a total of 39 times (36 sessions and 3 clinic visits) over a three-four month period. It will compare the effects (good or bad) of traditional acupuncture (TA) with alternative acupuncture (AA) on the menopausal symptoms to be studied in this research. Patients from WC group will be asked to come to Cedars-Siani a total of 15 times. Other study procedures include physical exam, blood and urine collection for hormone tests, questionnaire interview, etc.

During the pilot phase of this study subjects will record the number of mild, moderate, severe and/or very severe hot flashes that occur each day in a hot flash diary. There is also an option for patients to record other symptoms they may experience during that week other then hot flashes as well as a place for additional comments. Subjects will complete the diary for seven consecutive days. It is a simple form that takes very little time to complete each day (only 5-10 minutes) and will not impact the duration of the study participation.

No genetic study will be conducted in this pilot project.

Studietype

Intervensjonell

Registrering (Faktiske)

45

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • California
      • Los Angeles, California, Forente stater, 90048
        • Cedars-Sinai Women's Heart Center

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

40 år til 70 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  1. Women with menopausal Vasomotor symptoms (VMS) bothersome enough to warrant treatment;
  2. Minimum of 7 hot flashes per day (on average);
  3. Age limits: women ages 40-70 who have had at least one missed menstrual cycle or have undergone spontaneous menopause, women of any age who have medically induced menopause, women of any age who have had oophorectomy;
  4. Informed written consent;
  5. Ability to follow treatment protocols

Exclusion Criteria:

Exclusion Criteria (cohort):

  1. Concomitant illness with reasonable likelihood of limiting survival to less than one year;
  2. Current substance abuse (alcohol or drug);
  3. Pregnancy known, suspected or planned in next year;
  4. Non-English speaking patients
  5. Men

Exclusion Criteria (TA intervention):

  1. Other concomitant menopause treatment;
  2. Participating in acupuncture treatment or formal psychological stress management program within the last year;
  3. Participating in another treatment for VMS, unless willing to stop it 4 weeks in advance of participation;
  4. HIV infection, chronic or active hepatitis or other blood-borne illness.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: TA
Aktiv TA
In Traditional acupuncture (TA), in which eight acupuncture points are selected, subjects will undergo three 30-minute sessions weekly for 12 weeks. Disposable acupuncture needles (1-1.5 inch sterilized stainless steel)will be inserted up to one inch deep through a plastic needle tube that is secured with adhesive tape to the skin.
Andre navn:
  • Traditional Acupuncture
Aktiv komparator: AA
Alternative Acupuncture
In Alternative acupuncture (AA), in which eight acupuncture points are selected, subjects will undergo three 30-minute sessions weekly for 12 weeks. Disposable acupuncture needles (1-1.5 inch sterilized stainless steel)will be inserted up to one inch deep through a plastic needle tube that is secured with adhesive tape to the skin.
Andre navn:
  • Alternativ akupunktur
Aktiv komparator: WC
Waiting Group
Waiting Group
Andre navn:
  • Waiting Group

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
vasomotor symptoms (VMS) frequency and severity
Tidsramme: 3 months
vasomotor symptoms (VMS) frequency and severity
3 months

Sekundære resultatmål

Resultatmål
Tidsramme
The Pittsburgh Sleep Diary (PghSD)
Tidsramme: 60 minutes
60 minutes
Pittsburgh Sleep Quality Index (PSQI)
Tidsramme: 30minutes
30minutes
Beck Depression Inventory (BDI)
Tidsramme: 30 minutes
30 minutes

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. januar 2009

Primær fullføring (Faktiske)

1. februar 2010

Studiet fullført (Faktiske)

1. februar 2010

Datoer for studieregistrering

Først innsendt

30. juli 2009

Først innsendt som oppfylte QC-kriteriene

30. juli 2009

Først lagt ut (Anslag)

31. juli 2009

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. april 2019

Sist bekreftet

1. april 2019

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • IRB# 16997

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Ja

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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