Pregnancy Related Low Back PainNCT00571480
Use Ear Acupuncture as Treatment for Low Back Pain During Pregnancy
A study testing acupuncture in people with Pregnancy Related Low Back Pain, run by Yale University at 1 site in United States.
Trial summary
Ear acupuncture can be used as a treatment for pregnancy induced low back pain. Read more about this study
- Who is it for?
- Ages 13 to 46 years, women only
- Conditions the study is for
- Pregnancy Related Low Back Pain
- What is being tested?
- acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jan 2008
- 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 13 to 46 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- English speaking, healthy pregnant women in at least 25 weeks of gestational age who suffered from low back pain related to pregnancy.
- No obstetric complications during pregnancy or neurological complications that require immediate medical/surgical intervention.
Who cannot join
- Non-English speaking
- Mentally challenged
- State of pregnancy less than 25 weeks but suffer from pregnancy related low back pain
- Pregnant women without low back pain
- The pregnancy is complicated by obstetrical problems, or low back pain requiring immediate surgical/medical intervention.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acupuncture and Low Back Pain During Pregnancy
Ear acupuncture can be used as a treatment for pregnancy induced low back pain.
Read the detailed description
Ear acupuncture has been used as treatment for various pain symptoms. Pregnancy related low back pain can be debilitating for pregnant women but there is lack of effective treatment. Owing to the unique circulation system between mother and fetus, prenatal care providers and gravidae are reluctant to prescribe or accept the pharmacological intervention. Thus the goal of this clinical investigation is to determine whether ear acupuncture can be used as treatment for this special clinical entity. The participants are randomized into one of the three interventions based on a computer generated randomization table. These three interventions groups are: (1) True acupuncture (2) Sham acupuncture and (3) no acupuncture. All participants are allowed to use standard of care (SOC) as a rescue treatment and the SOC consists of acetaminophen 650 mg every 6 hours no more than 4 times per day, frequent rest and topical warm/cold compress. The participants in group 1 \& 2 received a total of three continuous retained ear acupuncture needles at three sites ipsilateral to the dominant hand in preselected ear acupuncture points for one week then after day 7. All participants are followed/observed for a total 2 weeks after the initiation of the study.
- Conditions
- Pregnancy Related Low Back Pain
- Being tested
- acupuncture, Sham acupuncture, standard of care
- Keywords
- auricular acupuncture, pregnancy related low back pain, acupuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
Also called retained ear acupuncture treatment
ear acupuncture needles will be inserted into three preselected acupuncture points which are thought to be specific for low back pain
Sham acupunctureOther
Also called retained ear acupuncture treatment
ear acupuncture needles are inserted into three preselected acupuncture points which are thought not specific to low back pain
standard of careOther
participants can take acetaminophen 650 mg no more than every 6 hours and frequent rest and topical warm/cold compress
| Study group | Role | What they receive |
|---|---|---|
| 1 true acupuncture | Experimental | acupuncture needles are inserted into three preselected ear acupuncture points which are thought to be specific for low back pain Receives: Other: acupuncture |
| 2 | Sham comparator | three acupuncture needles are inserted to three ear acupuncture points which are not specific for low back pain during pregnancy Receives: Other: Sham acupuncture |
| 3 | Other | standard of care Receives: Other: standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
severity pain
Measured: two weeks
Secondary outcomes (1)
daily disability index
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2007 (estimated)
- Study startFeb 2005
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy Related Low Back PainStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Investigators
- Shu-Ming Wang, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00571480
- Sponsor's protocol ID
- HIC 12291
- Other IDs
- 5R21AT001613-03
- Status last verified
- Jul 2009
- First submitted
- 10 Dec 2007
- Last updated
- 21 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture and Low Back Pain During Pregnancy
- ClinicalTrials.gov ID
- NCT00571480
- Acronym / sponsor ID
- HIC 12291
- Conditions
- Pregnancy Related Low Back Pain
- Keywords
- auricular acupuncture, pregnancy related low back pain, acupuncture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Feb 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 12 Dec 2007 (estimated)
- 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.
Ear acupuncture can be used as a treatment for pregnancy induced low back pain.
Detailed description
Ear acupuncture has been used as treatment for various pain symptoms. Pregnancy related low back pain can be debilitating for pregnant women but there is lack of effective treatment. Owing to the unique circulation system between mother and fetus, prenatal care providers and gravidae are reluctant to prescribe or accept the pharmacological intervention. Thus the goal of this clinical investigation is to determine whether ear acupuncture can be used as treatment for this special clinical entity. The participants are randomized into one of the three interventions based on a computer generated randomization table. These three interventions groups are: (1) True acupuncture (2) Sham acupuncture and (3) no acupuncture. All participants are allowed to use standard of care (SOC) as a rescue treatment and the SOC consists of acetaminophen 650 mg every 6 hours no more than 4 times per day, frequent rest and topical warm/cold compress. The participants in group 1 \& 2 received a total of three continuous retained ear acupuncture needles at three sites ipsilateral to the dominant hand in preselected ear acupuncture points for one week then after day 7. All participants are followed/observed for a total 2 weeks after the initiation of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 true acupuncture | Experimental | Other: acupunctureacupuncture needles are inserted into three preselected ear acupuncture points which are thought to be specific for low back pain |
| 2 | Sham comparator | Other: Sham acupuncturethree acupuncture needles are inserted to three ear acupuncture points which are not specific for low back pain during pregnancy |
| 3 | Other | Other: standard of carestandard of care |
Who may qualify
- Ages
- 13 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- English speaking, healthy pregnant women in at least 25 weeks of gestational age who suffered from low back pain related to pregnancy.
- No obstetric complications during pregnancy or neurological complications that require immediate medical/surgical intervention.
Key exclusion criteria (5 listed)
- Non-English speaking
- Mentally challenged
- State of pregnancy less than 25 weeks but suffer from pregnancy related low back pain
- Pregnant women without low back pain
- The pregnancy is complicated by obstetrical problems, or low back pain requiring immediate surgical/medical intervention.
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 |
|---|---|---|
| acupunctureAlso: retained ear acupuncture treatmentear acupuncture needles will be inserted into three preselected acupuncture points which are thought to be specific for low back pain | Other | 1 true acupuncture |
| Sham acupunctureAlso: retained ear acupuncture treatmentear acupuncture needles are inserted into three preselected acupuncture points which are thought not specific to low back pain | Other | 2 |
| standard of careparticipants can take acetaminophen 650 mg no more than every 6 hours and frequent rest and topical warm/cold compress | Other | 3 |
Primary outcome
severity pain
Time frame: two weeks
1 secondary outcome
daily disability index
Time frame: 2 weeks
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 21 Jul 2009.
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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.
Shu-Ming Wang, MD principal investigator
Yale University
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 Pregnancy Related Low Back Pain, run by Yale University at 1 site in United States.
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 2 inclusion and 5 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 21 Jul 2009. 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 United States. 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?
severity pain (time frame: two weeks). 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 21 Jul 2009.