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Clinical Trials/NCT02027038
NCT02027038CompletedNot Applicable

Pelvic Belt Effects on Osseous Anatomy, Muscule Activation and Ground Reaction Forces

University of Leipzig0 sites42 target enrollmentStarted: August 1, 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
42
Primary Endpoint
Change in pelvic bone alignment by pelvic belt, electromuscular activation, ground reaction force and in health outcome

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • Health related quality of life due to pelvic belt application(6 weeks)

Investigators

Sponsor
University of Leipzig
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Niels Hammer

Dr. Niels Hammer, M.D.

University of Leipzig

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