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

Acupuncture as a Treatment for Symphysiolysis Pain and Ability in Pregnant Women.

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.

Study Overview

• Status: Completed
• Conditions: Single Embryo Pregnancy; Gestational Weeks 24-42; Pain/Sensitivity >5 on Numeric Rating Scale (NRS)
• Intervention / Treatment: Procedure: acupuncture; Procedure: Sham acupuncture

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Shari Zedek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: true acupuncture; patient will get treatment according to the point the will help the symphysiolysis according to the Alternative medicine	Procedure: acupuncture; acupuncture
Sham Comparator: Sham acupuncture; patient will get treatment according to the point the will NOT help the symphysiolysis according to the Alternative medicine	Procedure: Sham acupuncture; Sham acupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement in the ability by using Modified Oswestry Disability Questionnaire (MODQ) - Questionnaire	To compare the functional effects of true and Sham acupuncture on the daily activities/ ability of women with symphysiolysis. the Questionnaire check the daily function of 10 daily activity's ( Pain Intensity ,Personal Care (e.g., Washing, Dressing) Lifting,Walking,Sitting,Standing,Sleeping,Social Life,Traveling,Employment / Homemaking). For each section the total possible score is 5: if the first statement - witch represent no restriction -is marked the section score = 0, if the last statement is marked-witch represen severe disability the score is 5. the total score number is calculated by : Score: /50 x 100 = ____% points Example: 16 (total scored-by the patient answers)/ 50 (total possible score) x 100 = 32%	48-72 hours

Collaborators and Investigators

• Sponsor: Shaare Zedek Medical Center
• Investigators: Principal Investigator: Menachem Oberbaum, MD, head of alternative medicine; Study Director: Sorina Grisaro, MD PhD, head of OBGYN department

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): January 30, 2021
• Study Completion (Actual): January 30, 2021

Study Registration Dates

• First Submitted: July 2, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Pregnancy Complications; Puerperal Disorders; Joint Dislocations; Diastasis, Bone; Pubic Symphysis Diastasis
• Other Study ID Numbers: 0115-18-SZMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No