Therapy Exercises and Physiotherapy Delivered Operant Conditioning in the Treatment Chronic Low Back Pain

Study Overview
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Brief Summary
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This study investigates the effect of two physiotherapy models in the treatment of chronic nonspecific low back pain. Participants will be divided into three groups, two experimental and one control. In both experimental groups, the participants will be included in the intensive program of Therapy Exercises, under the supervision and guidance of the physiotherapist, and the group will differ in implemented behavioral therapy (which he will implement by a physiotherapist). In the control group, subjects will receive the usual treatment. The Back School will be applied in all groups.

Detailed Description
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Low back pain is a global public health problem, one of the main causes of disability of the population, as well as enormous economic costs in the health system. This claim specifically relates to chronic low back pain. The clinical picture of chronic low back pain in addition to pain, muscle spasm, and functional disability dominate psychological problems, which significantly affect the outcome of treatment. The multidisciplinary approach to the treatment of chronic low back pain has proven to be the most effective, bad economically unacceptable, and unavailable in many countries. Therefore, it is necessary to find the most effective and economically most acceptable approach to the treatment of chronic low back pain. Physiotherapy is an unavoidable method of treating this painful condition, and changes in treatment approaches are most evident in this medical profession. Recently, physiotherapy includes two models in the treatment of chronic low back pain. A biomedical model consisting of well-known physiotherapy methods and a Biopsychosocial model that, in addition to known physiotherapy methods, includes a part of cognitive-behavioral therapy associated with motion and behavior, operative conditioning. Therapy exercise is an effective method indispensable part of both models of physiotherapy. The reason for changes in physiotherapy is a varied clinical picture of chronic low back pain. Evidence-based effectiveness of therapy exercise has been determined on reduction of the body's symptoms, pain, and functional disabilities. The effect of reducing psychological symptoms has been poorly investigated. Also, the use of therapeutic exercises in the practice creates several concerns related to the intensity of exercise, mode and time-frame of their application, and the type or method of exercise. Because it's already a known effect of operant conditioning through a multidisciplinary approach to reducing the psychological symptoms of chronic low back pain, it is suggested that this part of cognitive-behavioral therapy be implemented in physiotherapy, namely therapy exercise. Studies aimed to determine the effect of biopsychosocial physiotherapy models are scarce and insufficiently clear. The aims of this study are: Determine the effectiveness of a biomedical model of physiotherapy in the treatment of chronic nonspecific low back pain, Determine the effectiveness of the biopsychosocial model of physiotherapy in the treatment of chronic nonspecific low back pain, and Compare the effectiveness of these interventions.

Official Title
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Controlled, Randomized, Blind Trial Therapy Exercises and Operant Conditioning for Chronic Nonspecific Low Back Pain

Conditions
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Chronic Nonspecific Low Back Pain

Intervention / Treatment
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* Behavioral: Graded Activity
* Behavioral: Group-based Therapy Exercise
* Behavioral: Back School


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People with a diagnosis of nonspecific pain in the spinal area with symptoms of pain 3 and > months, confirmed by a doctor specialist family medicine, Age from 18 to 75 years of life, Both sexes. Exclusion Criteria: Acute and Subacute low back pain, Specific Low Back Pain, Operative interventions on the spine, Other health problems of the patient: pregnancy or gynecological diseases, blood vessels, elevated blood pressure, malignant and benign tumors in the spine, spinal abnormalities, spinal traumas, urological disorders and psychological disorders, Mental health problems that prevent the verbal expression and understanding of the questionnaire, and People who have been included in the therapeutic exercise program for the past 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: By randomization, the participants will be divided into three groups, two experimental groups, and a control group. In the first experimental group, the investigated interventions will consist of Therapy Exercise and Back School. In the second experimental group, in addition to the Therapy Exercise and the Back School, operative conditioning will be performed by the master of physiotherapy. The participants in the control group will be exposed to the usual treatment.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biomedical (Physiotherapy) group<br>Therapy Exercise and Back School; 8 sessions during 4 weeks (2 times a week), with one session lasting 60 min. | Behavioral: Group-based Therapy Exercise<br>* Aerobic exercise, Stretching exercise and flexibility, Range of motion, Balance and coordination, Breathing exercises Stabilization exercise Muscle strength training exercise<br>* Other names: Exercises Therapy, Kinesitherapy;Behavioral: Back School<br>* Basic information of Low Back Pain - anatomy, physiology, causes, treatment. Correct postures - standing, sitting, driving, sleeping, Correct body movements - lifting, pushing, walking.<br>|
| Experimental: Biopsychosocial (Graded Activity) group<br>Operant Conditioning implement in Physiotherapy, Therapy Exercises and Back School; 8 sessions during 4 weeks (2 times a week), with one session lasting 60 min. | Behavioral: Graded Activity<br>* Active participation of participants, Overcoming and eliminating negative behaviors, Encouraging positive behavior in pain, Overcoming the fear of the movement, Motivation to implementation pre-set specific goals.<br>* Other names: Physiotherapy - Provided Operant Conditioning;Behavioral: Group-based Therapy Exercise<br>* Aerobic exercise, Stretching exercise and flexibility, Range of motion, Balance and coordination, Breathing exercises Stabilization exercise Muscle strength training exercise<br>* Other names: Exercises Therapy, Kinesitherapy;Behavioral: Back School<br>* Basic information of Low Back Pain - anatomy, physiology, causes, treatment. Correct postures - standing, sitting, driving, sleeping, Correct body movements - lifting, pushing, walking.<br>|
| No Intervention: Usual care<br>Usual care and written instructions on Therapy Exercise and Back School for self-care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analog Scale (VAS) Pain Score | Self-reported pain intensity, Each item scored 0-100 mm (0=No pain; 100=Pain as bad as can be). | Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Roland Morris Disability Questionnaire (RMDQ) Score | Self-reported assessment of functional disability in low back pain. It consists of 24 questions that question how crossbreeding affects daily activities, and is calculated by a sum of total answers of 0 to 24. A larger sum indicates greater disability. | Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization | 
| Change in Goniometry of spine (ROM) Score | Functional assessment of range of motion in lumbal spine with goniometer - flexion, extension and latero-flexion right and left; | Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization | 
| Change in Finger to Floor Test (FTF) | Functional assessment of lumbar spine flexion; with a centimeters band the distance between the middle finger and the floor is measured. | Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization | 
| Change in Prone Double Straight Leg Raise Test (PDSLRT) Score | Assessment of muscle strength back extensors, measures are in seconds. | Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization | 
| Change in Hospital Anxiety and Depression Scale (HAD) Score | Self-assessment intensity of depression and anxiety. It consists of 14 questions, 7 questions for assessing depression and 7 for assessing anxiety. Responses are scored at four levels from 0 to 3 (0 = not at all, 3 = all the time) so the results may vary from 0 to 21 for depression or anxiety. Respondents with scores 0-7 are not depressed/anxious, 8-10 indicate a marginal state and 11-21 represent depression/anxiety. | Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization | 
| Change in Fear-Avoidance Beliefs Questionnaire (FABQ) Score | Assessment to avoid movement due to fear of pain. It consists of 16 particles and each question is evaluated from 0 to 6. A higher score indicates a greater presence of fear/avoidance. FABQ is divided into two parts (work and physical activity), one measures the correlation of work with the current feeling of pain in low back pain, and the second connection of physical activity on the current sense of pain in low back pain. | Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization | 
| Change in Short Form Health Survey 12 (SF-12) core | Questionnaire of assessment quality of life. The instrument by which the subjective sense of individual health is measured through 12 questions examines the physical, psychological, and social consequences caused by impaired health. With this questionnaire, it is possible to quantitatively compare each dimension of health, because the score for each question is transformed into standard values and placed on the scale from 0 to 100 (the higher the score the better health) and thus get two major dimensions of health: physical (Physical Common Score-PCS)and mental health (Mental Common Score-MCS). | Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization | 
| Questionnaire assessment of satisfaction with treatment | The assessment of satisfaction with interventions as well as cost-effectiveness was measured using single questions and answers on the 5-item Likert scale, from completely dissatisfied to completely satisfied. | 6 month post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Graded Activity, Low Back Pain, Nonspecific, Operant Conditioning, Therapy Exercise