Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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) ;


Study Design


Related Conditions & MeSH terms


NCT number NCT01591824
Study type Interventional
Source Omphis Foundation
Contact
Status Completed
Phase N/A
Start date May 2012
Completion date September 2015

See also
  Status Clinical Trial Phase
Recruiting NCT06009263 - Effect of Open Chain Versus Closed Chain Segmental Control Exercises on CSA of Lumbar Multifidus Muscle in Chronic MLBP N/A
Completed NCT05052840 - Effects of Back Muscles Endurance Training in Patients With Chronic Mechanical Low Back Pain N/A
Completed NCT04562701 - Relationship Between Hamstring Length and Gluteus Maximums in Mechanical Low Back Pain
Not yet recruiting NCT04542798 - CRF vs WCRF or PRF-DRG in CLBP of FJ Origin and RFA Failure of MBDR: Central Sensitization and Aberrant Nerve Sprouting N/A
Terminated NCT02276794 - Thrust Versus Non-thrust Manipulation in Chronic Low Back Pain N/A
Recruiting NCT01940744 - Prescriptive Mobilization Versus a Pragmatic Mobilization N/A
Completed NCT02226692 - Prognostic Factors of Disabling Low Back Pain in Patients With Chronic Low Back Pain N/A
Recruiting NCT05616702 - Effectiveness of Pressure Biofeedback Therapy and Progressive Muscle Relaxation Technique in Improving Pain and Disability Among Patients With Non-Specific Low Back Pain N/A
Recruiting NCT02622789 - Efficacy and Influence of Pilates Based Physical Therapy Exercises for Low Back Pain N/A
Not yet recruiting NCT05088031 - Shock Wave Therapy Versus Mechanical Traction on Mechanical Low Back Pain
Not yet recruiting NCT06330792 - Effect of Bio-mechanical Awareness and Core Stability Exercises on Mechanical Low Back Pain N/A
Completed NCT03949179 - Optimizing Management of Low Back Pain Through the Pain and Disability Drivers Management Model
Completed NCT03517410 - Association Between the Duration of Smart Phone Use and Back Dysfunction in Patients With Low Back Pain
Completed NCT02239289 - Use of Biofeedback Training to Correct Abnormal Neuromechanical Pattern in Chronic Low Back Pain Patients N/A
Recruiting NCT05404997 - Comparative Effects of SWT and Maitland LM in Mechanical LBP N/A
Completed NCT05475912 - Effect of Talocrural Joint Thrust Manipulation on Mechanical Low Back Pain N/A
Not yet recruiting NCT04726579 - CBD Oil in Mechanical Back Pain
Recruiting NCT02491879 - Ketoprofen Gel vs Placebo in Low Back Pain Phase 4
Completed NCT01557049 - Global Postural Reeducation in Chronic Low Back Pain N/A
Enrolling by invitation NCT05860283 - Core Stability Exercise Versus Diaphragmatic Release on Respiratory Functions on Physical Therapists With Low Back Pain N/A