Pelvic Belt Effects on Osseous Anatomy, Muscule Activation and Ground Reaction Forces
Primary Purpose
Sacroiliac Joint Pain, Helath Related Quality of Life, Electromuscular Activation of the Pelis and Limbs
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Pelvic belt application
Sponsored by
About this trial
This is an interventional treatment trial for Sacroiliac Joint Pain
Eligibility Criteria
Inclusion Criteria:
- patients with diagnostically confirmed sacroiliac joint pain
- controls without any history of musculoskeletal disorders
Exclusion Criteria:
- endoprostheses, metallic implants
- somatoform disorders, claustrophobia, pregnancy
- surgical interventions on the spine, degenerative joint diseases elsewhere
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with sacroiliac joint pain
Controls
Arm Description
Patients suffering from sacroiliac joint pain
healthy controls
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Health related quality of life due to pelvic belt application
starting point: end of primary outcome measure ending point: 6 weeks
Full Information
NCT ID
NCT02027038
First Posted
January 1, 2014
Last Updated
January 1, 2014
Sponsor
University of Leipzig
Collaborators
Bauerfeind AG, Zeulenroda-Triebes
1. Study Identification
Unique Protocol Identification Number
NCT02027038
Brief Title
Pelvic Belt Effects on Osseous Anatomy, Muscule Activation and Ground Reaction Forces
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
Collaborators
Bauerfeind AG, Zeulenroda-Triebes
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sacroiliac Joint Pain, Helath Related Quality of Life, Electromuscular Activation of the Pelis and Limbs, Ground Reaction Force Data
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with sacroiliac joint pain
Arm Type
Experimental
Arm Description
Patients suffering from sacroiliac joint pain
Arm Title
Controls
Arm Type
Active Comparator
Arm Description
healthy controls
Intervention Type
Device
Intervention Name(s)
Pelvic belt application
Primary Outcome Measure Information:
Title
Change in pelvic bone alignment by pelvic belt, electromuscular activation, ground reaction force and in health outcome
Description
First application of pelvic belt = starting point No compression, moderate and maximum compression Health survey completion = end point
Time Frame
3-5 hours
Secondary Outcome Measure Information:
Title
Health related quality of life due to pelvic belt application
Description
starting point: end of primary outcome measure ending point: 6 weeks
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with diagnostically confirmed sacroiliac joint pain
controls without any history of musculoskeletal disorders
Exclusion Criteria:
endoprostheses, metallic implants
somatoform disorders, claustrophobia, pregnancy
surgical interventions on the spine, degenerative joint diseases elsewhere
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Hammer, M.D.
Organizational Affiliation
University of Leipzig
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
26305790
Citation
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. Erratum In: PLoS One. 2015;10(10):e0140090.
Results Reference
derived
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Pelvic Belt Effects on Osseous Anatomy, Muscule Activation and Ground Reaction Forces
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