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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Mechanical Low Back Pain
 Other: Resonant oscillation
Other: column exercise group
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Effectiveness of Resonant Oscillation, According to the Pold Concept in Chronic Nonspecific Low Back Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Omphis Foundation:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: January 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: POLD TREATMENT
Patients who applies the treatment of resonant oscillation according to the Pold Concept
 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
Active Comparator: CONVENCIONAL
Patients who applied the conventional treatment of hospital
 Other: column exercise group
  • paraspinal muscle stretching exercises
  • postural correction
  • mobilization exercises thoracic and lumbar
  • Motor control exercises
Other Name: motor control

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01591824

Contacts
Contact: Juan V. López, Physiotherapy 0034-609724888 juanlopez@pold.es
Contact: Alejandra P. Aros, Physiotherapy 0034-679901990 alex@omphis.es

Locations
Spain
Esperanza Hospital Recruiting
Barcelona, Spain, 08024
Contact: Juan V. López, Physiotherapy     0034-609724888     juanlopez@pold.es    
Principal Investigator: Juan V. López, physiotherapy            
Sponsors and Collaborators
Omphis Foundation
Investigators
Study Director: José M. Muniesa, physiatrist Esperanza Hospital (Barcelona)
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: JUAN V. LOPEZ DIAZ, Degree in physiotherapy kinesiology and physiatry, Omphis Foundation
ClinicalTrials.gov Identifier: NCT01591824     History of Changes
Other Study ID Numbers: Pold-LBP
Study First Received: May 1, 2012
Last Updated: May 2, 2012
Health Authority: Spain: Clinical Research Ethics Committee Parc de Salut MAR
Spain: Rehabilitation Department of Esperanza Hospital (Barcelona)

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013