search
Back to results

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
University of Leipzig
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sacroiliac Joint Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    January 1, 2014
    Last Updated
    January 1, 2014
    Sponsor
    University of Leipzig
    Collaborators
    Bauerfeind AG, Zeulenroda-Triebes
    search

    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

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs