Effectiveness of Resonant Oscillation, According to the Pold Concept in Chronic Nonspecific Low Back Pain
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- VAS pain measurement
Study Overview
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.
Detailed Description
Type of study:
This is an analytical study, the experimental group clinical trial type, controlled, randomized with complete randomization and single blind.
Two groups, the study to which the POLD treatment shall apply, and the control group with conventional treatment will be formed by complete randomization system as they arrive for consultation, with a total of 50 patients or more if they were needed for each group have a minimum of 25 having offset dropouts. The number of 25 patients per group is determined considering accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, are required at least 21 subjects in each group to detect a minimum difference of 15 percentage points between the two groups, therefore two groups of 25 assuming a standard deviation of 15 points and a loss rate of 0% tracking form.
We will study both the effectiveness and efficiency individually and comparatively between groups.
- Study population:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 70 Years (Adult, Older Adult)
- Sex
- 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
- •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.
Arms & Interventions
POLD TREATMENT
Patients who applies the treatment of resonant oscillation according to the Pold Concept
Intervention: Resonant oscillation (Other)
CONVENCIONAL: column exercise group
Patients who applied the conventional treatment of hospital
Intervention: column exercise group (Other)
Outcomes
Primary Outcomes
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 Outcomes
- SF-12 Health Survey(Participants will be followed for the duration of treatment application, an expected average of 3 weeks.)
- Oswestry Disability Index(Participants will be followed for the duration of treatment application, an expected average of 3 weeks.)
Investigators
JUAN V. LOPEZ DIAZ
Degree in physiotherapy kinesiology and physiatry
Omphis Foundation