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

NCT ID: NCT04471285

Last Updated: 2022-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-01
• Study Completion Date: 2021-01-30

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.

Detailed Description

the investigators recruit women who diagnose with symphysiolisis by having 2 out of 3 of the follow:

• Examine for pain or sensitivity to touch on pubic symphysis joint.
• Modified Trendelenburg's test
• Active straight leg raise test 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.

Women will be randomly divided at a 1:1 ratio, according to the randomized number chart prepared by the trial's statistician. The list of random numbers will be delivered to the head of the acupuncturist team and it will be the only copy in existence aside from the one belonging to the statistician. According to that list of numbers, the head acupuncturist will instruct the acupuncturist on call as to the type of acupuncture to be performed, true (V) vs. placebo (P) on the participant . The type of acupuncture (V or P) will be recorded in the woman's chart.

The treatment will be conducted by one of the acupuncturists on staff at the integrative medical center. All the acupuncturists have many years of experience in treating pregnant women with Chinese medicine. The acupuncture will be carried out with 0.18/40mm single use needles. Point selection and numbers of points used will be determined following the evaluation of the acupuncturist according to the accepted standards of in Chinese medicine. They will not, however, deviate from the list of true acupuncture points in the list of possible true paints . Placebo acupuncture will be three to four points selected at random from the list of placebo points . The acupuncturist's evaluation in the placebo group will be the same as in the evaluation in the treatment group and the true acupuncture points selected during that time will be the ones used in case of failure and continued pain following the first (placebo) treatment, after cross over.

It should be noted that the woman's assessment and the exam will take place before the acupuncture treatment begins, whether it is the true or placebo group.

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 our team 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

true acupuncture

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

Group Type: ACTIVE_COMPARATOR

acupuncture

Intervention Type: PROCEDURE

acupuncture

Sham acupuncture

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

Group Type: SHAM_COMPARATOR

Sham acupuncture

Intervention Type: PROCEDURE

Sham acupuncture

Interventions

acupuncture

acupuncture

Intervention Type: PROCEDURE

Sham acupuncture

Sham acupuncture

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shaare Zedek Medical Center

OTHER

Sponsor Role: lead

Responsible Party

jaffea

OBGYN resident, MD MPH

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Menachem Oberbaum, MD

Role: PRINCIPAL_INVESTIGATOR

head of alternative medicine

Sorina Grisaro, MD PhD

Role: STUDY_DIRECTOR

head of OBGYN department

Locations

Shari Zedek Medical Center

Jerusalem, , Israel

Countries

Israel

Other Identifiers

0115-18-SZMC

Identifier Type: -

Identifier Source: org_study_id