Condition or disease | Intervention/treatment | Phase |
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Low Back Pain | Behavioral: Operant conditioning Behavioral: Therapy Exercises in Group Behavioral: Back School | Not Applicable |
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 affects the outcome of treatment. The multidisciplinary approach to 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 treatment of chronic low back pain. Physiotherapy is an unavoidable method of treating this painful condition, and changes in treatment approach are most evident in this medical profession. Recently, physiotherapy includes two models in the treatment chronic low back pain. 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. Therapeutic exercise as a effective method indispensable part in both models of physiotherapy.
The reason of changes in physiotherapy is a varied clinical picture of chronic low back pain. The proven effect of therapeutic exercises has been determined to reduce 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 a number of 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 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 therapeutic exercise. Research to determine the effect of biopsychosocial physiotherapy models is scarce and insufficiently clear.
The aims of this research are:
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | By randomization, the subjects will be divided into three groups, two trial groups and a control group. In the first experimental group, the investigated interventions will consist of therapeutic exercises and back school. In the second experimental group, in addition to the therapeutic exercises and the back school, operative conditioning will be performed by the magister physiotherapy. The subjects in the control group will be exposed to the usual treatment. |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Due to the nature of interventions that will be applied in this study, blinding of therapists who will carry out the intervention regarding therapeutic exercises will not be possible to implement, but physiotherapists (apart creators of research) will not know the research hypothesis. Fully blinding of the examinees is also impossible to implement, but partially blinding will occur, as the patients in the biopsychosocial group will not explain the applied behavioral therapy. Blinding will be applied to researchers who will collect data (measure outcomes) and statisticians. |
Primary Purpose: | Treatment |
Official Title: | Controlled, Randomized, Blind Trial Therapy Exercises and Operant Conditioning for Chronic Nonspecific Low Back Pain |
Actual Study Start Date : | May 1, 2019 |
Actual Primary Completion Date : | November 30, 2019 |
Actual Study Completion Date : | December 30, 2019 |
Arm | Intervention/treatment |
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Experimental: Biomedical group
Therapy Exercises and Back School by month, 2 times a week for 60 minutes.
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Behavioral: Therapy Exercises in Group
Aerobic exercises, Stretching exercises and flexibility, Range of motion, Balance and coordination, Breathing exercises Stabilization exercises Muscle strength training exercises
Other Name: Exercises Therapy, Kinesitherapy
Behavioral: Back School Basic information on low back pain - anatomy, physiology, causes, treatment. Correct postures - standing, sitting, driving, sleeping, Correct body movements - lifting, pushing, walking.
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Experimental: Biopsychosocial group
Operant Conditioning implement in physiotherapy, Therapy Exercises and Back School by month, 2 times a week for 60 minutes.
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Behavioral: Operant conditioning
Active participation of respondents, Overcoming and eliminating negative behaviors, Encouraging positive behavior in pain, Overcoming the fear of the movement, Motivation to implementation pre-set specific goals.
Behavioral: Therapy Exercises in Group Aerobic exercises, Stretching exercises and flexibility, Range of motion, Balance and coordination, Breathing exercises Stabilization exercises Muscle strength training exercises
Other Name: Exercises Therapy, Kinesitherapy
Behavioral: Back School Basic information on low back pain - anatomy, physiology, causes, treatment. Correct postures - standing, sitting, driving, sleeping, Correct body movements - lifting, pushing, walking.
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No Intervention: Usual care
Usual care and written instructions on Therapeutic Exercises and Back School for home work.
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Assessment to avoid movement due to fear of pain, before and after the intervention, 3. i 6. after randomization.
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.
Assessment quality of life, before and after the intervention, 3. i 6. month after randomization.
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 are 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 and mental health, Physical Common Score-PCS and Mental Common Score-MCS.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Bosnia and Herzegovina | |
Dom zdravlja Mostar | |
Mostar, Bosnia and Herzegovina, 88000 | |
Rehabilitacijski centar "Život" | |
Mostar, Bosnia and Herzegovina, 88000 |
Principal Investigator: | Antonija Hrkać | Faculty of Health Science |
Tracking Information | |||||||||||||||||||
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First Submitted Date ICMJE | July 14, 2019 | ||||||||||||||||||
First Posted Date ICMJE | July 17, 2019 | ||||||||||||||||||
Last Update Posted Date | January 10, 2020 | ||||||||||||||||||
Actual Study Start Date ICMJE | May 1, 2019 | ||||||||||||||||||
Actual Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Current Primary Outcome Measures ICMJE |
VAS - Visual Analog Scale [ Time Frame: < 1 minutes ] Self-reported pain intensity, before randomization, after completion of the intervention, 3 and 6 months after randomization. Each item scored 0-100 mm (0=No pain; 100=Pain as bad as can be).
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Change History | |||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
Descriptive Information | |||||||||||||||||||
Brief Title ICMJE | Therapy Exercises and Physiotherapy Delivered Operant Conditioning in the Treatment Chronic Low Back Pain | ||||||||||||||||||
Official Title ICMJE | Controlled, Randomized, Blind Trial Therapy Exercises and Operant Conditioning for Chronic Nonspecific Low Back Pain | ||||||||||||||||||
Brief Summary | This research 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 therapeutic exercises, under the supervision and guidance of the physiotherapist, and the group will differ in that a group of cognitive-behavioral therapies will be implemented by a physiotherapist, operative conditioning. In the control group, subjects will recive the usual treatment. The Back school will be applied in all groups. | ||||||||||||||||||
Detailed Description |
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 affects the outcome of treatment. The multidisciplinary approach to 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 treatment of chronic low back pain. Physiotherapy is an unavoidable method of treating this painful condition, and changes in treatment approach are most evident in this medical profession. Recently, physiotherapy includes two models in the treatment chronic low back pain. 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. Therapeutic exercise as a effective method indispensable part in both models of physiotherapy. The reason of changes in physiotherapy is a varied clinical picture of chronic low back pain. The proven effect of therapeutic exercises has been determined to reduce 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 a number of 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 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 therapeutic exercise. Research to determine the effect of biopsychosocial physiotherapy models is scarce and insufficiently clear. The aims of this research are:
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Study Type ICMJE | Interventional | ||||||||||||||||||
Study Phase ICMJE | Not Applicable | ||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: By randomization, the subjects will be divided into three groups, two trial groups and a control group. In the first experimental group, the investigated interventions will consist of therapeutic exercises and back school. In the second experimental group, in addition to the therapeutic exercises and the back school, operative conditioning will be performed by the magister physiotherapy. The subjects in the control group will be exposed to the usual treatment. Masking: Single (Outcomes Assessor)Masking Description: Due to the nature of interventions that will be applied in this study, blinding of therapists who will carry out the intervention regarding therapeutic exercises will not be possible to implement, but physiotherapists (apart creators of research) will not know the research hypothesis. Fully blinding of the examinees is also impossible to implement, but partially blinding will occur, as the patients in the biopsychosocial group will not explain the applied behavioral therapy. Blinding will be applied to researchers who will collect data (measure outcomes) and statisticians. Primary Purpose: Treatment
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Condition ICMJE | Low Back Pain | ||||||||||||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||
Recruitment Status ICMJE | Completed | ||||||||||||||||||
Actual Enrollment ICMJE |
180 | ||||||||||||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||
Actual Study Completion Date ICMJE | December 30, 2019 | ||||||||||||||||||
Actual Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||||||||||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||
Listed Location Countries ICMJE | Bosnia and Herzegovina | ||||||||||||||||||
Removed Location Countries | |||||||||||||||||||
Administrative Information | |||||||||||||||||||
NCT Number ICMJE | NCT04023162 | ||||||||||||||||||
Other Study ID Numbers ICMJE | Studija I | ||||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Antonija Hrkać, University of Mostar | ||||||||||||||||||
Study Sponsor ICMJE | Antonija Hrkać | ||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||
Investigators ICMJE |
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PRS Account | University of Mostar | ||||||||||||||||||
Verification Date | July 2019 | ||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |