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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01591824
Recruitment Status : Completed
First Posted : May 4, 2012
Last Update Posted : April 9, 2019
Information provided by (Responsible Party):
JUAN V. LOPEZ DIAZ, Omphis Foundation

Brief Summary:

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 or disease Intervention/treatment Phase
Mechanical Low Back Pain Other: Resonant oscillation Other: column exercise group Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Resonant Oscillation, According to the Pold Concept in Chronic Nonspecific Low Back Pain
Study Start Date : May 2012
Actual Primary Completion Date : July 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
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: column exercise group
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

Primary Outcome Measures :
  1. VAS pain measurement [ Time Frame: Participants will be followed for the duration of treatment application, an expected average of 3 weeks. ]
    Visual analog scale of pain measurement, with values between zero and ten where zero is total absence of pain and 10 the maximum pain imaginable by the patient, distributed in a horizontal line, without intermediate numerical or graphic references.

Secondary Outcome Measures :
  1. SF-12 Health Survey [ Time Frame: Participants will be followed for the duration of treatment application, an expected average of 3 weeks. ]

    The Health Questionnaire SF-12 is the adaptation made for Spain of the SF-12 Health Survey. The SF-12 is a reduced version of the SF-36 Health Questionnaire.

    This instrument provides a profile of the state of health and is one of the most widely used generic scales in the evaluation of clinical outcomes, being applicable both for the general population and for patients with a minimum age of 14 years and both in descriptive studies and in evaluation.

    It consists of 12 items from the 8 dimensions of SF-36: Physical Function (2), Social Function (1), Physical Role (2), Emotional Role (2), Mental Health (2), Vitality (1), Pain body (1), General Health (1). Response options form Likert-type scales that evaluate intensity or frequency.

    The number of response options ranges from three to six, depending on the item

  2. Oswestry Disability Index [ Time Frame: Participants will be followed for the duration of treatment application, an expected average of 3 weeks. ]

    The self-completed questionnaire contains ten topics concerning intensity of pain, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel.

    Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.

    The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01591824

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Esperanza Hospital
Barcelona, Spain, 08024
Sponsors and Collaborators
Omphis Foundation
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Study Director: José M. Muniesa, physiatrist Esperanza Hospital (Barcelona)

Additional Information:
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Responsible Party: JUAN V. LOPEZ DIAZ, Degree in physiotherapy kinesiology and physiatry, Omphis Foundation Identifier: NCT01591824     History of Changes
Other Study ID Numbers: Pold-LBP
First Posted: May 4, 2012    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms