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

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ClinicalTrials.gov Identifier: NCT04471285
Recruitment Status : Recruiting
First Posted : July 15, 2020
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
jaffea, Shaare Zedek Medical Center

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.


Condition or disease Intervention/treatment Phase
Single Embryo Pregnancy Gestational Weeks 24-42 Pain/Sensitivity >5 on Numeric Rating Scale (NRS) Procedure: acupuncture Procedure: Sham acupuncture Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acupuncture as a Treatment for Symphysiolysis Pain and Ability in Pregnant Women.
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : January 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

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




Primary Outcome Measures :
  1. pain improvement [ Time Frame: 30 minutes ]
    improvement of 1.5 marks on the Numeric Rating Scale (NRS) ( 0-10 , 0=no pain, 10=worst pain) as describe by the patient.


Secondary Outcome Measures :
  1. improvement in the ability by using Modified Oswestry Disability Questionnaire (MODQ) - Questionnaire [ Time Frame: 48-72 hours ]

    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%




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04471285


Contacts
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Contact: arie Jaffe, MD,MPH 972545365359 jaffea@gmail.com

Locations
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Israel
Shari Zedek Medical Center Recruiting
Jerusalem, Israel
Contact: arie jaffe, MD MPH       jaffea@gmail.com   
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Menachem Oberbaum, MD head of alternative medicine
Study Director: Sorina Grisaro, MD PhD head of OBGYN department
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Responsible Party: jaffea, OBGYN resident, MD MPH, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT04471285    
Other Study ID Numbers: 0115-18-SZMC
First Posted: July 15, 2020    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pubic Symphysis Diastasis
Diastasis, Bone
Joint Dislocations
Joint Diseases
Musculoskeletal Diseases
Puerperal Disorders
Pregnancy Complications
Wounds and Injuries