Sacroiliac Joint PainNCT02027038
Pelvic Belt Effects on Osseous Anatomy, Muscule Activation and Ground Reaction Forces
A study testing Pelvic belt application in people with Sacroiliac Joint Pain and Helath Related Quality of Life, run by University of Leipzig.
Trial summary
Hypothesis I: The anatomic alignment of the pelvic bones, the electromuscular activation of limb muscles and ground reaction forces are different in patients with sacroiliac joint pain, as compared to healthy controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sacroiliac Joint Pain, Helath Related Quality of Life, Electromuscular Activation of the Pelis and Limbs
- What is being tested?
- Pelvic belt application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Jan 2013
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with diagnostically confirmed sacroiliac joint pain
- controls without any history of musculoskeletal disorders
Who cannot join
- endoprostheses, metallic implants
- somatoform disorders, claustrophobia, pregnancy
- surgical interventions on the spine, degenerative joint diseases elsewhere
About this study
Hypothesis I: The anatomic alignment of the pelvic bones, the electromuscular activation of limb muscles and ground reaction forces are different in patients with sacroiliac joint pain, as compared to healthy controls.
Hypothesis II: The application of pelvic belts alters the alignment of the pelvic bones, the electromuscular activation of the limb muscles or ground reaction forces.
Hypothesis III: The effects proposed in hypothesis II are different in patients with sacroiliac joint pain, as compared to healthy controls.
Read the detailed description
The sacroiliac joint is among the most frequently involved anatomical structure in low back pain. Pelvic belt anatomy makes the sacroiliac joint more vulnerable to be involved in chronic painful conditions. However, the anatomical and functional correlate of sacroiliac joint pain is yet undetermined. According to the guidelines of International Association for the Study of Pain (IASP), painful conditions should primarily be managed conservatively.
However, existing studies fail providing sound evidence on the effects of conservative devices to therapy sacroiliac joint pain. In the study, a total of 17 patients suffering from sacroiliac joint pain and 17 controls were investigated by means of magnetic resonance imaging, EMG, health surveys and ground reaction force measurements.
A pelvic compression belt was administered in two levels of compression and the corresponding magnetic resonance imaging, EMG and ground reaction force data were measured.
- Conditions
- Sacroiliac Joint Pain, Helath Related Quality of Life, Electromuscular Activation of the Pelis and Limbs, Ground Reaction Force Data
- Being tested
- Pelvic belt application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic belt applicationDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients with sacroiliac joint pain | Experimental | Patients suffering from sacroiliac joint pain Receives: Device: Pelvic belt application |
| Controls | Active comparator | healthy controls Receives: Device: Pelvic belt application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pelvic bone alignment by pelvic belt, electromuscular activation, ground reaction force and in health outcome
First application of pelvic belt = starting point No compression, moderate and maximum compression Health survey completion = end point
Measured: 3-5 hours
Secondary outcomes (1)
Health related quality of life due to pelvic belt application
starting point: end of primary outcome measure ending point: 6 weeks
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startAug 2011
- Primary completionDec 2012
- Study completionJan 2013
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 Sacroiliac Joint 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Bauerfeind AG, Zeulenroda-Triebes
- Responsible party
- Principal investigator, Niels Hammer, University of Leipzig
- Investigators
- Niels Hammer, M.D., Principal investigator, University of Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027038
- Sponsor's protocol ID
- 063/11/07032011
- Status last verified
- Jan 2014
- First submitted
- 1 Jan 2014
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hammer N, Mobius R, Schleifenbaum S, Hammer KH, Klima S, Lange JS, Soisson O, Winkler D, Milani TL. Pelvic Belt Effects on Health Outcomes and Functional Parameters of Patients with Sacroiliac Joint Pain. PLoS One. 2015 Aug 25;10(8):e0136375. doi: 10.1371/journal.pone.0136375. eCollection 2015.
PubMed 26305790
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pelvic Belt Effects on Osseous Anatomy, Muscule Activation and Ground Reaction Forces
- ClinicalTrials.gov ID
- NCT02027038
- Acronym / sponsor ID
- 063/11/07032011
- Conditions
- Sacroiliac Joint Pain, Helath Related Quality of Life, Electromuscular Activation of the Pelis and Limbs, Ground Reaction Force Data
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Bauerfeind AG, Zeulenroda-Triebes
- Study start
- Aug 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 3 Jan 2014 (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.
Hypothesis I: The anatomic alignment of the pelvic bones, the electromuscular activation of limb muscles and ground reaction forces are different in patients with sacroiliac joint pain, as compared to healthy controls.
Hypothesis II: The application of pelvic belts alters the alignment of the pelvic bones, the electromuscular activation of the limb muscles or ground reaction forces.
Hypothesis III: The effects proposed in hypothesis II are different in patients with sacroiliac joint pain, as compared to healthy controls.
Detailed description
The sacroiliac joint is among the most frequently involved anatomical structure in low back pain. Pelvic belt anatomy makes the sacroiliac joint more vulnerable to be involved in chronic painful conditions. However, the anatomical and functional correlate of sacroiliac joint pain is yet undetermined. According to the guidelines of International Association for the Study of Pain (IASP), painful conditions should primarily be managed conservatively.
However, existing studies fail providing sound evidence on the effects of conservative devices to therapy sacroiliac joint pain. In the study, a total of 17 patients suffering from sacroiliac joint pain and 17 controls were investigated by means of magnetic resonance imaging, EMG, health surveys and ground reaction force measurements.
A pelvic compression belt was administered in two levels of compression and the corresponding magnetic resonance imaging, EMG and ground reaction force data were measured.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with sacroiliac joint pain | Experimental | Device: Pelvic belt applicationPatients suffering from sacroiliac joint pain |
| Controls | Active comparator | Device: Pelvic belt applicationhealthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients with diagnostically confirmed sacroiliac joint pain
- controls without any history of musculoskeletal disorders
Key exclusion criteria (3 listed)
- endoprostheses, metallic implants
- somatoform disorders, claustrophobia, pregnancy
- surgical interventions on the spine, degenerative joint diseases elsewhere
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 |
|---|---|---|
| Pelvic belt application | Device | Controls, Patients with sacroiliac joint pain |
Primary outcome
Change in pelvic bone alignment by pelvic belt, electromuscular activation, ground reaction force and in health outcome
Time frame: 3-5 hours
First application of pelvic belt = starting point No compression, moderate and maximum compression Health survey completion = end point
1 secondary outcome
Health related quality of life due to pelvic belt application
Time frame: 6 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 3 Jan 2014.
- Derived from this study: PubMed 26305790Hammer N, Mobius R, Schleifenbaum S, Hammer KH, Klima S, Lange JS, Soisson O, Winkler D, Milani TL. Pelvic Belt Effects on Health Outcomes and Functional Parameters of Patients with Sacroiliac Joint Pain. PLoS One. 2015 Aug 25;10(8):e0136375. doi: 10.1371/journal.pone.0136375. eCollection 2015.
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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.
Niels Hammer, M.D. principal investigator
University of Leipzig
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic belt application in people with Sacroiliac Joint Pain and Helath Related Quality of Life, run by University of Leipzig.
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 3 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 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in pelvic bone alignment by pelvic belt, electromuscular activation, ground reaction force and in health outcome (time frame: 3-5 hours). 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 NCT02027038, 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 3 Jan 2014.