Pelvic Girdle PainNCT01098136
Pelvic Girdle Pain in a Pregnant Population in Western Norway.
A study testing Chiropractic, Conventional medical intervention and Conventional and alternative intervention in people with Pelvic Girdle Pain, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
The objectives in this study are 1. to explore the incidence and cumulative prevalence of pelvic girdle pain (PGP) and its subgroups in a prospective longitudinal study during pregnancy, from 18 weeks until 6 weeks after delivery. 2. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Girdle Pain
- What is being tested?
- Chiropractic, Conventional medical intervention and Conventional and alternative intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2010to Dec 2011
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Lumbopelvic pain
- Pelvic pain
- Performed ultrasound examination at 18th pregnancy week
- Expected normal pregnancy without complications
- Good competency in Norwegian language
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Norway1 site
Stavanger University Hospital, Department of Obstetrics and Gynaecology
Stavanger, 4068
About this study
Official title: A Study of Pelvic Girdle Pain in a Pregnant Population in Western Norway - Incidence, Cumulative Prevalence, Course and Intervention.
The objectives in this study are
- to explore the incidence and cumulative prevalence of pelvic girdle pain (PGP) and its subgroups in a prospective longitudinal study during pregnancy, from 18 weeks until 6 weeks after delivery.
- to examine the outcome of chiropractic management for a dominating one-sided PGP subgroup of pregnant women in a single-blinded controlled study, and to use efficacy measures that include pain, functional impairment, and sick-leave frequency.
- to investigate possible predictors for treatment outcome in one-sided PGP in pregnant women.
- Conditions
- Pelvic Girdle Pain
- Being tested
- Chiropractic, Conventional medical intervention, Conventional and alternative intervention
- Keywords
- Pelvic girdle pain, Chiropractic, Single-blinded, Outcome study
- Medical subject headings
- Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChiropracticOther
Manual treatment of musculoskeletal complaints
Conventional medical interventionOther
Medical, physiotherapy
Conventional and alternative interventionOther
Medical and alternative methods for treatment of pelvic pain syndromes
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic treatment | Active comparator | Management for one-sided pelvic pain, as decided by the chiropractor Receives: Other: Chiropractic |
| Conventional health care | Active comparator | Conventional health care for one-sided pelvic pain Receives: Other: Conventional medical intervention |
| Conventional and alternative treatment | Active comparator | Treament of pregnant women with other pelvic pain syndromes. Receives: Other: Conventional and alternative intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
P4/thigh thrust
As outcome measures we are using pain provocation tests (P4/thigh thrust, Patrick's Faber, Gaenslen's test, and modified Trendelenburg's test), pain palpation tests (long dorsal ligament test and palpation of the symphysis), and a functional test, the active straight leg raise (ASLR) test. All tests are published and described in European guidelines on pelvic girdle pain (PGP). Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. Epub 2008 Feb 8.
Measured: Outcome is assessed at follow-up examination 6 weeks post-partum
Secondary outcomes (1)
Oswestry Disability Index
The Oswestry Disability Index is one of the principal condition-specific outcome measures the last 30 years for management of disabling effects from spinal disorders
Measured: Outcome is assessed at follow-up examination 6 weeks post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Girdle PainStudies 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
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- University of Stavanger
- Responsible party
- Sponsor
- Investigators
- Stefan Malmquist, DC MSc, Principal investigator, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01098136
- Sponsor's protocol ID
- 2010/174-4
- Status last verified
- Aug 2012
- First submitted
- 22 Mar 2010
- Last updated
- 31 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Gausel AM, Kjaermann I, Malmqvist S, Andersen K, Dalen I, Larsen JP, Okland I. Chiropractic management of dominating one-sided pelvic girdle pain in pregnant women; a randomized controlled trial. BMC Pregnancy Childbirth. 2017 Sep 29;17(1):331. doi: 10.1186/s12884-017-1528-9.
PubMed 28962596
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Pelvic Girdle Pain in a Pregnant Population in Western Norway - Incidence, Cumulative Prevalence, Course and Intervention.
- ClinicalTrials.gov ID
- NCT01098136
- Acronym / sponsor ID
- 2010/174-4
- Conditions
- Pelvic Girdle Pain
- Keywords
- Pelvic girdle pain, Chiropractic, Single-blinded, Outcome study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- University of Stavanger
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Apr 2010 (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.
The objectives in this study are
- to explore the incidence and cumulative prevalence of pelvic girdle pain (PGP) and its subgroups in a prospective longitudinal study during pregnancy, from 18 weeks until 6 weeks after delivery.
- to examine the outcome of chiropractic management for a dominating one-sided PGP subgroup of pregnant women in a single-blinded controlled study, and to use efficacy measures that include pain, functional impairment, and sick-leave frequency.
- to investigate possible predictors for treatment outcome in one-sided PGP in pregnant women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chiropractic treatment | Active comparator | Other: ChiropracticManagement for one-sided pelvic pain, as decided by the chiropractor |
| Conventional health care | Active comparator | Other: Conventional medical interventionConventional health care for one-sided pelvic pain |
| Conventional and alternative treatment | Active comparator | Other: Conventional and alternative interventionTreament of pregnant women with other pelvic pain syndromes. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Lumbopelvic pain
- Pelvic pain
- Performed ultrasound examination at 18th pregnancy week
- Expected normal pregnancy without complications
- Good competency in Norwegian language
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| ChiropracticManual treatment of musculoskeletal complaints | Other | Chiropractic treatment |
| Conventional medical interventionMedical, physiotherapy | Other | Conventional health care |
| Conventional and alternative interventionMedical and alternative methods for treatment of pelvic pain syndromes | Other | Conventional and alternative treatment |
Primary outcome
P4/thigh thrust
Time frame: Outcome is assessed at follow-up examination 6 weeks post-partum
As outcome measures we are using pain provocation tests (P4/thigh thrust, Patrick's Faber, Gaenslen's test, and modified Trendelenburg's test), pain palpation tests (long dorsal ligament test and palpation of the symphysis), and a functional test, the active straight leg raise (ASLR) test. All tests are published and described in European guidelines on pelvic girdle pain (PGP). Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. Epub 2008 Feb 8.
1 secondary outcome
Oswestry Disability Index
Time frame: Outcome is assessed at follow-up examination 6 weeks post-partum
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 31 Aug 2012.
- Derived from this study: PubMed 28962596Gausel AM, Kjaermann I, Malmqvist S, Andersen K, Dalen I, Larsen JP, Okland I. Chiropractic management of dominating one-sided pelvic girdle pain in pregnant women; a randomized controlled trial. BMC Pregnancy Childbirth. 2017 Sep 29;17(1):331. doi: 10.1186/s12884-017-1528-9.
Related trials for Pelvic Girdle Pain
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Symphysis Pubis Dysfunction, Pregnancy
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Effects of Rehabilitation on Cesarean Scar Symptoms and Physical Recovery
Cesarean Birth, Massage
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Effects of MET With and Without Lumbopelvic Manipulation
Anterior Pelvic Tilt
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Osteopathy in Postpartum Lumbopelvic Pain
Postpartum Lumbopelvic Pain, Postpartum Pelvic Girdle Pain
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.
Stefan Malmquist, DC MSc principal investigator
Helse Stavanger HF
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic, Conventional medical intervention and Conventional and alternative intervention in people with Pelvic Girdle Pain, run by Helse Stavanger HF at 1 site in Norway.
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 5 inclusion and 0 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 31 Aug 2012. 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 Norway. 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. 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?
P4/thigh thrust (time frame: Outcome is assessed at follow-up examination 6 weeks post-partum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01098136, which also lists 1 linked publication.
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 31 Aug 2012.