Symphysiolysis: Acupuncture Therapeutic Benefits: a Randomized Placebo Controlled Study.

NCT04471285 | Completed

• 1 other identifier: 0115-18-SZMC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

a randomized, observer blind and placebo-controlled cross-over study in which true acupuncture (Verum)(V) was compared to "placebo" acupuncture (P). the investigators evaluate the effect of the acupuncture on the pain and the ability of the pregnant patient.

Conditions

Single Embryo Pregnancy; Gestational Weeks 24-42; Pain/Sensitivity >5 on Numeric Rating Scale (NRS)

Outcome Measures

Primary Outcomes (1)

• pain improvement

  improvement of 1.5 marks on the Numeric Rating Scale (NRS) ( 0-10 , 0=no pain, 10=worst pain) as describe by the patient.

  30 minutes

Secondary Outcomes (1)

• improvement in the ability by using Modified Oswestry Disability Questionnaire (MODQ) - Questionnaire

  48-72 hours

Study Arms (2)

true acupuncture

ACTIVE COMPARATOR

patient will get treatment according to the point the will help the symphysiolysis according to the Alternative medicine

Procedure: acupuncture

Sham acupuncture

SHAM COMPARATOR

patient will get treatment according to the point the will NOT help the symphysiolysis according to the Alternative medicine

Procedure: Sham acupuncture

Interventions

acupuncture PROCEDURE

acupuncture

true acupuncture

Sham acupuncture PROCEDURE

Sham acupuncture

Sham acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women \> 18 years
• Single embryo pregnancy in week 24-42
• was diagnosed with symphysiolisis according to written above
• Pain/sensitivity \>5 on NRS scale in symphysis pubis area for more than two weeks

You may not qualify if:

• Lack of proficiency in Hebrew or English
• Pain from a different source
• pelvic bone disease or history of severe pelvic bone injury
• Thrombocytopenia (plt\<50.000)
• Acupuncture treatment is contraindicated
• High risk pregnancy

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shari Zedek Medical Center

Jerusalem, Israel

Location

MeSH Terms

Interventions

Acupuncture Therapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Menachem Oberbaum, MD

  head of alternative medicine

  PRINCIPAL INVESTIGATOR

• Sorina Grisaro, MD PhD

  head of OBGYN department

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: OBGYN resident, MD MPH

Model Details: The trial doctor will mark the woman's chart with a continuous number that will become her number in the trial, and she will then be referred to the acupuncturist. , she will receive an acupuncture treatment according to the randomized numbers for acupuncture V or acupuncture P. Approximately 30 minutes after the acupuncture treatment began, the woman will be asked once again to assess her level of pain. An improvement of 1.5 marks on the NRS scale is considered a positive response. Women whose response after 30 minutes of acupuncture is less than this will be given the opposite acupuncture treatment. Those who received V acupuncture will receive P acupuncture and those who received P acupuncture will receive V acupuncture. A woman will be called again if her pain is significantly worse. She will then receive the treatment that has been found most effective between the two acupuncture treatments she received previously.

Study Record Dates

• First Submitted: July 2, 2020
• First Posted: July 15, 2020
• Study Start: July 1, 2018
• Primary Completion: January 30, 2021
• Study Completion: January 30, 2021
• Last Updated: May 4, 2022

Record last verified: 2022-05

Locations

IL (1)