Clinical trial NCT04471285: Symphysiolysis: Acupuncture Therapeutic Benefits: a Randomized Placebo Controlled Study.
Official title: Acupuncture as a Treatment for Symphysiolysis Pain and Ability in Pregnant Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Single Embryo Pregnancy
Gestational Weeks 24-42
Pain/Sensitivity >5 on Numeric Rating Scale (NRS)
Lead sponsor: Shaare Zedek Medical Center
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: pain improvement
timeFrame: 30 minutes
Secondary outcomes:
measure: improvement in the ability by using Modified Oswestry Disability Questionnaire (MODQ) - Questionnaire
timeFrame: 48-72 hours
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Shari Zedek Medical Center
Study officials:
affiliation: head of alternative medicine
name: Menachem Oberbaum, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: head of OBGYN department
name: Sorina Grisaro, MD PhD
role: STUDY_DIRECTOR
References: