Pelvic Girdle Pain Post PartumNCT00974103
Persistent Low Back and Pelvic Pain 3-6 Months Post Partum
A study testing exercise advise and chiropractic treatment and exercises in people with Pelvic Girdle Pain Post Partum and Low Back Pain Post Partum, run by Helse Stavanger HF at 1 site in Norway.
Trial summary
The purpose of this study is to identify how many females have persistent low back pain and/or pelvic pain 3-6 months post partum. The females that have persistent pelvic pain can continue in the study and be examined by a chiropractor. They will then divide the females into Hanne Alberts 5 subgroups of pelvic pain. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Pelvic Girdle Pain Post Partum, Low Back Pain Post Partum
- What is being tested?
- exercise advise and chiropractic treatment and exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2009to Aug 2010
- 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 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Low back and\or pelvic girdle pain during pregnancy
- Fluent understanding of spoken and written Norwegian
Who cannot join
- hospitalisation due to pain or complications post partum
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Persistent Low Back Pain and Pelvic Pain 3-6 Months Post Partum
The purpose of this study is to identify how many females have persistent low back pain and/or pelvic pain 3-6 months post partum. The females that have persistent pelvic pain can continue in the study and be examined by a chiropractor. They will then divide the females into Hanne Alberts 5 subgroups of pelvic pain. The females that have one-sided pelvic pain will be invited to participate in a randomised controlled study where chiropractic intervention is compared to exercises.
Read the detailed description
The study is a follow up study to "Prevalence of low back pain and pelvic pain in the pregnant population in Stavanger".
- Being tested
- exercise advise, chiropractic treatment and exercises
- Keywords
- low back pain, pelvic pain, pelvic girdle pain, post partum
- Medical subject headings
- Low Back Pain, Pelvic Pain, Pelvic Girdle Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise adviseOther
Also called Pregnancy, Back pain, Exercise, Post partum
Exercises
chiropractic treatment and exercisesOther
Also called Manipulation, Pregnancy, Back pain, Exercise
Manipulation, mobilisation, soft tissue work, ergonomic and exercise advise. Maximum 12 treatments
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic treatment, exercise | Experimental | Chiropractic treatment and exercise Receives: Other: chiropractic treatment and exercises |
| Exercises | Experimental | Exercise advise Receives: Other: exercise advise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index
Measured: 20 weeks after the initial assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Girdle Pain Post PartumStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helse Stavanger HF
- Sponsor type
- Other government
- Collaborators
- University of Stavanger
- Responsible party
- Sponsor
- Investigators
- Jan P Larsen, MD Dr med, Study director, Helse Stavanger HF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974103
- Sponsor's protocol ID
- 2009/798
- Other IDs
- 2009/798
- Status last verified
- Aug 2012
- First submitted
- 9 Sep 2009
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Low Back Pain and Pelvic Pain 3-6 Months Post Partum
- ClinicalTrials.gov ID
- NCT00974103
- Acronym / sponsor ID
- 2009/798
- Keywords
- low back pain, pelvic pain, pelvic girdle pain, post partum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Helse Stavanger HFOther government
- Collaborators
- University of Stavanger
- Study start
- Sep 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 10 Sep 2009 (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 purpose of this study is to identify how many females have persistent low back pain and/or pelvic pain 3-6 months post partum. The females that have persistent pelvic pain can continue in the study and be examined by a chiropractor. They will then divide the females into Hanne Alberts 5 subgroups of pelvic pain. The females that have one-sided pelvic pain will be invited to participate in a randomised controlled study where chiropractic intervention is compared to exercises.
Detailed description
The study is a follow up study to "Prevalence of low back pain and pelvic pain in the pregnant population in Stavanger".
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiropractic treatment, exercise | Experimental | Other: chiropractic treatment and exercisesChiropractic treatment and exercise |
| Exercises | Experimental | Other: exercise adviseExercise advise |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Low back and\or pelvic girdle pain during pregnancy
- Fluent understanding of spoken and written Norwegian
Key exclusion criteria (1 listed)
- hospitalisation due to pain or complications post partum
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 |
|---|---|---|
| exercise adviseAlso: Pregnancy, Back pain, Exercise, Post partumExercises | Other | Exercises |
| chiropractic treatment and exercisesAlso: Manipulation, Pregnancy, Back pain, ExerciseManipulation, mobilisation, soft tissue work, ergonomic and exercise advise. Maximum 12 treatments | Other | Chiropractic treatment, exercise |
Primary outcome
Oswestry Disability Index
Time frame: 20 weeks after the initial assessment
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 3 Sep 2012.
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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.
Jan P Larsen, MD Dr med study director
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 exercise advise and chiropractic treatment and exercises in people with Pelvic Girdle Pain Post Partum and Low Back Pain Post Partum, 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 2 inclusion and 1 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 3 Sep 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?
Oswestry Disability Index (time frame: 20 weeks after the initial assessment). 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 3 Sep 2012.