Study of Effectiveness of Pold in Chronic Nonspecific Low Back Pain (Pold-LBP)

This study is currently recruiting participants.
Verified May 2012 by Omphis Foundation
Sponsor:
Information provided by (Responsible Party):
JUAN V. LOPEZ DIAZ, Omphis Foundation
ClinicalTrials.gov Identifier:
NCT01591824
First received: May 1, 2012
Last updated: May 2, 2012
Last verified: May 2012

May 1, 2012
May 2, 2012
January 2012
December 2012   (final data collection date for primary outcome measure)
VAS pain measurement [ Time Frame: Participants will be followed for the duration of treatment application, an expected average of 3 weeks. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01591824 on ClinicalTrials.gov Archive Site
  • SF-12 Health Survey [ Time Frame: Participants will be followed for the duration of treatment application, an expected average of 3 weeks. ] [ Designated as safety issue: No ]
  • Oswestry test [ Time Frame: Participants will be followed for the duration of treatment application, an expected average of 3 weeks. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Effectiveness of Pold in Chronic Nonspecific Low Back Pain
Effectiveness of Resonant Oscillation, According to the Pold Concept in Chronic Nonspecific Low Back Pain

Through this research is to conduct a pilot clinical trial in the treatment of chronic nonspecific low back pain (degenerative and mechanical), by comparing two groups, one that will apply a technique of physiotherapy by passive movement of the column with oscillations in axial rotation at a frequency of 1.5 to 2 cps (resonance) of low amplitude (called "Pold Concept"), another group that applies the standard protocol of treatment for this condition, as used in the hospital where performed the study.

It will compare the levels of efficiency and effectiveness of each treatment and the comparison between them. This will measure the perception of pain intensity and disability.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Mechanical Low Back Pain
  • Other: Resonant oscillation

    Resonant sustained oscillations are applied in the following areas

    • general column.
    • lumbar muscles, and paraspinal muscles,
    • sacral decompression oscillatory
    • Opening by lateral vertebral lumbar rhythmic swing.
    • Balancing and pelvic decompression
    • Swing-lumbar vertebral rotation.
    Other Name: oscillatory movement
  • Other: column exercise group
    • paraspinal muscle stretching exercises
    • postural correction
    • mobilization exercises thoracic and lumbar
    • Motor control exercises
    Other Name: motor control
  • Experimental: POLD TREATMENT
    Patients who applies the treatment of resonant oscillation according to the Pold Concept
    Intervention: Other: Resonant oscillation
  • Active Comparator: CONVENCIONAL
    Patients who applied the conventional treatment of hospital
    Intervention: Other: column exercise group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
February 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Having a diagnosis instrumental prior to treatment to rule out pathologies pollutants, neurological or structural malformations.
  • No previous trauma.
  • Age between 25 and 65.
  • With similar clinical characteristics to have a homogenous group:

    • Low back pain (> 3 months) and that at the time the study began have a minimum of 3/10 on VAS scale, following the criteria established in similar studies
    • without component of neurological lower limbs irradiation

Exclusion Criteria:

  • Existence of other recent traumatic structural pathologies in the lumbar region or of another type that could disturb the study.
  • Existence of irradiation metameric to lower limbs
  • Current tumors in the lumbar region
  • Ongoing infectious disease in the lumbar area.
  • Inflammatory rheumatism in the lumbar region.
  • Lumbar surgery complications.
  • Ongoing pregnancy.
  • They have been treated with infiltrations in the last month.
  • Who are following any other treatment, whether manual or physical agents or alternative or complementary therapies.
Both
25 Years to 65 Years
No
Contact: Juan V. López, Physiotherapy 0034-609724888 juanlopez@pold.es
Contact: Alejandra P. Aros, Physiotherapy 0034-679901990 alex@omphis.es
Spain
 
NCT01591824
Pold-LBP
No
JUAN V. LOPEZ DIAZ, Omphis Foundation
Omphis Foundation
Not Provided
Study Director: José M. Muniesa, physiatrist Esperanza Hospital (Barcelona)
Omphis Foundation
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP