Single Embryo PregnancyNCT04471285
Symphysiolysis: Acupuncture Therapeutic Benefits: a Randomized Placebo Controlled Study.
A study testing acupuncture in people with Single Embryo Pregnancy and Gestational Weeks 24-42, run by Shaare Zedek Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Single Embryo Pregnancy, Gestational Weeks 24-42, Pain/Sensitivity >5 on Numeric Rating Scale (NRS)
- What is being tested?
- acupuncture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jul 2018to 30 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Being tested
- acupuncture, Sham acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureProcedure or surgery
acupuncture
Sham acupunctureProcedure or surgery
Sham acupuncture
| Study group | Role | What they receive |
|---|---|---|
| true acupuncture | Active comparator | patient will get treatment according to the point the will help the symphysiolysis according to the Alternative medicine Receives: 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 Receives: Procedure: Sham acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes
Secondary outcomes (1)
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%
Measured: 48-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start1 Jul 2018
- Primary completion30 Jan 2021
- Study completion30 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Embryo PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, jaffea, Shaare Zedek Medical Center
- Investigators
- Menachem Oberbaum, MD, Principal investigator, head of alternative medicineSorina Grisaro, MD PhD, Study director, head of OBGYN department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471285
- Sponsor's protocol ID
- 0115-18-SZMC
- Status last verified
- May 2022
- First submitted
- 2 Jul 2020
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture as a Treatment for Symphysiolysis Pain and Ability in Pregnant Women.
- ClinicalTrials.gov ID
- NCT04471285
- Acronym / sponsor ID
- 0115-18-SZMC
- Conditions
- Single Embryo Pregnancy, Gestational Weeks 24-42, Pain/Sensitivity >5 on Numeric Rating Scale (NRS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| true acupuncture | Active comparator | Procedure: acupuncturepatient will get treatment according to the point the will help the symphysiolysis according to the Alternative medicine |
| Sham acupuncture | Sham comparator | Procedure: Sham acupuncturepatient will get treatment according to the point the will NOT help the symphysiolysis according to the Alternative medicine |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureacupuncture | Procedure or surgery | true acupuncture |
| Sham acupunctureSham acupuncture | Procedure or surgery | Sham acupuncture |
Primary outcome
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.
1 secondary outcome
improvement in the ability by using Modified Oswestry Disability Questionnaire (MODQ) - Questionnaire
Time frame: 48-72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Menachem Oberbaum, MD principal investigator
head of alternative medicine
Sorina Grisaro, MD PhD study director
head of OBGYN department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture in people with Single Embryo Pregnancy and Gestational Weeks 24-42, run by Shaare Zedek Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain improvement (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2022.