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

NCT ID: NCT02027038

Last Updated: 2014-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-01-31

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.

Conditions

Sacroiliac Joint Pain; Helath Related Quality of Life; Electromuscular Activation of the Pelis and Limbs; Ground Reaction Force Data

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with sacroiliac joint pain

Patients suffering from sacroiliac joint pain

Group Type: EXPERIMENTAL

Pelvic belt application

Intervention Type: DEVICE

Controls

healthy controls

Group Type: ACTIVE_COMPARATOR

Pelvic belt application

Intervention Type: DEVICE

Interventions

Pelvic belt application

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bauerfeind AG, Zeulenroda-Triebes

UNKNOWN

Sponsor Role: collaborator

University of Leipzig

OTHER

Sponsor Role: lead

Responsible Party

Niels Hammer

Dr. Niels Hammer, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Niels Hammer, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Leipzig

References

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.

Reference Type: DERIVED

PMID: 26305790 (View on PubMed)

Other Identifiers

063/11/07032011

Identifier Type: -

Identifier Source: org_study_id