Clinical trial NCT04023162: Therapy Exercises and Physiotherapy Delivered Operant Conditioning in the Treatment Chronic Low Back Pain
Official title: Controlled, Randomized, Blind Trial Therapy Exercises and Operant Conditioning for Chronic Nonspecific Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Nonspecific Low Back Pain
Keywords: Low Back Pain
Nonspecific
Operant Conditioning
Graded Activity
Therapy Exercise
Lead sponsor: University of Mostar
Sponsor class: OTHER
First posted: 2019-07-17
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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:

1. Determine the effectiveness of a biomedical model of physiotherapy in the treatment of chronic nonspecific low back pain,
2. Determine the effectiveness of the biopsychosocial model of physiotherapy in the treatment of chronic nonspecific low back pain, and
3. Compare the effectiveness of these interventions.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Visual Analog Scale (VAS) Pain Score
timeFrame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Secondary outcomes:
measure: Change in Roland Morris Disability Questionnaire (RMDQ) Score
timeFrame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
measure: Change in Goniometry of spine (ROM) Score
timeFrame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
measure: Change in Finger to Floor Test (FTF)
timeFrame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
measure: Change in Prone Double Straight Leg Raise Test (PDSLRT) Score
timeFrame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
measure: Change in Hospital Anxiety and Depression Scale (HAD) Score
timeFrame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
measure: Change in Fear-Avoidance Beliefs Questionnaire (FABQ) Score
timeFrame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
measure: Change in Short Form Health Survey 12 (SF-12) core
timeFrame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
measure: Questionnaire assessment of satisfaction with treatment
timeFrame: 6 month post-randomization
Other outcomes:
Locations:
city: Mostar
country: Bosnia and Herzegovina
facility: Dom zdravlja Mostar
city: Mostar
country: Bosnia and Herzegovina
facility: Rehabilitacijski centar "Život"
Study officials:
affiliation: Faculty of Health Science
name: Antonija Hrkać
role: PRINCIPAL_INVESTIGATOR
References:
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