Study of Effectiveness of Pold in Chronic Nonspecific Low Back Pain (Pold-LBP)
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|ClinicalTrials.gov Identifier: NCT01591824|
Recruitment Status : Completed
First Posted : May 4, 2012
Last Update Posted : April 9, 2019
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|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|
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
Other Name: oscillatory movement
Active Comparator: CONVENCIONAL: column exercise group
Patients who applied the conventional treatment of hospital
Other: column exercise group
Other Name: motor control
- 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.
- 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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01591824
|Barcelona, Spain, 08024|
|Study Director:||José M. Muniesa, physiatrist||Esperanza Hospital (Barcelona)|