Clinical trial NCT01591824: Study of Effectiveness of Pold in Chronic Nonspecific Low Back Pain
Official title: Effectiveness of Resonant Oscillation, According to the Pold Concept in Chronic Nonspecific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mechanical Low Back Pain
Lead sponsor: Omphis Foundation
Sponsor class: OTHER
First posted: 2012-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

  1. The sample was selected from patients attending the clinic with back pain and after medical diagnosis are referred to the physiotherapist report of diagnosis, prescribing physical therapy and who meet the criteria for inclusion and not exclusion .
  2. A total of 25 patients in the experimental group and 25 for the standard treatment group are selected.
  3. If losses to the sample will be replaced by others to maintain proportions.
* The selection of groups:

RANDOM will be used , he formed the experimental group and control directing patients overall are being incorporated randomly according to the study :

1. Group A ( study ) will apply the technique with an identical protocol POLD them all.

2. Group B (conventional control) was applied average conventional treatment of different physiotherapy centers of reference.

* Study variables to collect:

  1. Subjective assessment of pain intensity using VAS, visual analog pain. ,
  2. Evolution of disability by Oswestry test.
  3. SF-12 on health.
* Statistical analysis:

Computer analysis using "SPSS" 13.0 ® processed program. The study will be processed as follows:

First, an initial analysis was performed to verify that there were no significant differences between groups in baseline values of the dependent variables by Student's t test for independent samples.

Second : For each dependent variable variance analysis is applied using a general linear model with 2x10 between subjects factor we call variable " Treatment " with two categories 1, 2 (experimental group = 1, conventional group = 2 ) and a temporal within-subjects factor we call "SHOOT" ( 10 sessions) .

Third: We analyze to what treatment session the differences between the two groups appear by Student's t test for independent data after the first session

Fourth, the interactions are studied by comparing the two groups after the first, fifth and 10th session using a Student t test for independent data and comparing the results of each group between 1st and 5th session and between 1st and 10th session with a Student t for paired data.

• Ethical Issues: During the study of national and international guidelines (code of ethics, Declaration of Helsinki) will continue, likewise the legal regulations on data privacy (Law 15 /1999 of 13 December on the Protection of Personal Data)

Eligibility 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.

Primary outcomes:
measure: VAS pain measurement
timeFrame: Participants will be followed for the duration of treatment application, an expected average of 3 weeks.
Secondary outcomes:
measure: SF-12 Health Survey
timeFrame: Participants will be followed for the duration of treatment application, an expected average of 3 weeks.
measure: Oswestry Disability Index
timeFrame: Participants will be followed for the duration of treatment application, an expected average of 3 weeks.
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Esperanza Hospital
Study officials:
affiliation: Esperanza Hospital (Barcelona)
name: José M. Muniesa, physiatrist
role: STUDY_DIRECTOR
References: