Clinical trial NCT02027038: Pelvic Belt Effects on Osseous Anatomy, Muscule Activation and Ground Reaction Forces
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliac Joint Pain
Helath Related Quality of Life
Electromuscular Activation of the Pelis and Limbs
Ground Reaction Force Data
Lead sponsor: University of Leipzig
Sponsor class: OTHER
Collaborators: name: Bauerfeind AG, Zeulenroda-Triebes
First posted: 2014-01-03
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in pelvic bone alignment by pelvic belt, electromuscular activation, ground reaction force and in health outcome
timeFrame: 3-5 hours
Secondary outcomes:
measure: Health related quality of life due to pelvic belt application
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: University of Leipzig
name: Niels Hammer, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.