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

Primary Purpose

Chronic Nonspecific Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Bosnia and Herzegovina
Study Type
Interventional
Intervention
Graded Activity
Group-based Therapy Exercise
Back School
Sponsored by
Antonija Hrkać
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Nonspecific Low Back Pain focused on measuring Low Back Pain, Nonspecific, Operant Conditioning, Graded Activity, Therapy Exercise

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dom zdravlja Mostar
  • Rehabilitacijski centar "Život"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Biomedical (Physiotherapy) group

Biopsychosocial (Graded Activity) group

Usual care

Arm Description

Therapy Exercise and Back School; 8 sessions during 4 weeks (2 times a week), with one session lasting 60 min.

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.

Usual care and written instructions on Therapy Exercise and Back School for self-care.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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;
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.
Change in Prone Double Straight Leg Raise Test (PDSLRT) Score
Assessment of muscle strength back extensors, measures are in seconds.
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.
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.
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).
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.

Full Information

First Posted
July 14, 2019
Last Updated
February 18, 2022
Sponsor
Antonija Hrkać
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1. Study Identification

Unique Protocol Identification Number
NCT04023162
Brief Title
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

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Antonija Hrkać

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Nonspecific Low Back Pain
Keywords
Low Back Pain, Nonspecific, Operant Conditioning, Graded Activity, Therapy Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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 Therapy Exercise will not be possible to implement, but physiotherapists (apart from the study designer) will not know the study hypothesis. Fully blinding of the examinees is also impossible to implement, but partially blinding will occur, as the participants in the Graded Activity group will not explain the applied behavioral therapy. Blinding will be applied to researchers who will collect data (measure outcomes) and statisticians.
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biomedical (Physiotherapy) group
Arm Type
Experimental
Arm Description
Therapy Exercise and Back School; 8 sessions during 4 weeks (2 times a week), with one session lasting 60 min.
Arm Title
Biopsychosocial (Graded Activity) group
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care and written instructions on Therapy Exercise and Back School for self-care.
Intervention Type
Behavioral
Intervention Name(s)
Graded Activity
Other Intervention Name(s)
Physiotherapy - Provided Operant Conditioning
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group-based Therapy Exercise
Other Intervention Name(s)
Exercises Therapy, Kinesitherapy
Intervention Description
Aerobic exercise, Stretching exercise and flexibility, Range of motion, Balance and coordination, Breathing exercises Stabilization exercise Muscle strength training exercise
Intervention Type
Behavioral
Intervention Name(s)
Back School
Intervention Description
Basic information of Low Back Pain - anatomy, physiology, causes, treatment. Correct postures - standing, sitting, driving, sleeping, Correct body movements - lifting, pushing, walking.
Primary Outcome Measure Information:
Title
Change in Visual Analog Scale (VAS) Pain Score
Description
Self-reported pain intensity, Each item scored 0-100 mm (0=No pain; 100=Pain as bad as can be).
Time Frame
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Secondary Outcome Measure Information:
Title
Change in Roland Morris Disability Questionnaire (RMDQ) Score
Description
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.
Time Frame
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Title
Change in Goniometry of spine (ROM) Score
Description
Functional assessment of range of motion in lumbal spine with goniometer - flexion, extension and latero-flexion right and left;
Time Frame
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Title
Change in Finger to Floor Test (FTF)
Description
Functional assessment of lumbar spine flexion; with a centimeters band the distance between the middle finger and the floor is measured.
Time Frame
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Title
Change in Prone Double Straight Leg Raise Test (PDSLRT) Score
Description
Assessment of muscle strength back extensors, measures are in seconds.
Time Frame
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Title
Change in Hospital Anxiety and Depression Scale (HAD) Score
Description
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.
Time Frame
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Title
Change in Fear-Avoidance Beliefs Questionnaire (FABQ) Score
Description
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.
Time Frame
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Title
Change in Short Form Health Survey 12 (SF-12) core
Description
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).
Time Frame
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Title
Questionnaire assessment of satisfaction with treatment
Description
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.
Time Frame
6 month post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonija Hrkać
Organizational Affiliation
Faculty of Health Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dom zdravlja Mostar
City
Mostar
ZIP/Postal Code
88000
Country
Bosnia and Herzegovina
Facility Name
Rehabilitacijski centar "Život"
City
Mostar
ZIP/Postal Code
88000
Country
Bosnia and Herzegovina

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Anyone who wishes to access the data.
Citations:
PubMed Identifier
24462839
Citation
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Results Reference
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PubMed Identifier
27712027
Citation
Wong JJ, Cote P, Sutton DA, Randhawa K, Yu H, Varatharajan S, Goldgrub R, Nordin M, Gross DP, Shearer HM, Carroll LJ, Stern PJ, Ameis A, Southerst D, Mior S, Stupar M, Varatharajan T, Taylor-Vaisey A. Clinical practice guidelines for the noninvasive management of low back pain: A systematic review by the Ontario Protocol for Traffic Injury Management (OPTIMa) Collaboration. Eur J Pain. 2017 Feb;21(2):201-216. doi: 10.1002/ejp.931. Epub 2016 Oct 6.
Results Reference
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PubMed Identifier
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Henschke N, Ostelo RW, van Tulder MW, Vlaeyen JW, Morley S, Assendelft WJ, Main CJ. Behavioural treatment for chronic low-back pain. Cochrane Database Syst Rev. 2010 Jul 7;2010(7):CD002014. doi: 10.1002/14651858.CD002014.pub3.
Results Reference
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27871193
Citation
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PubMed Identifier
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Citation
Lamb SE, Hansen Z, Lall R, Castelnuovo E, Withers EJ, Nichols V, Potter R, Underwood MR; Back Skills Training Trial investigators. Group cognitive behavioural treatment for low-back pain in primary care: a randomised controlled trial and cost-effectiveness analysis. Lancet. 2010 Mar 13;375(9718):916-23. doi: 10.1016/S0140-6736(09)62164-4. Epub 2010 Feb 25.
Results Reference
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PubMed Identifier
27417610
Citation
Gordon R, Bloxham S. A Systematic Review of the Effects of Exercise and Physical Activity on Non-Specific Chronic Low Back Pain. Healthcare (Basel). 2016 Apr 25;4(2):22. doi: 10.3390/healthcare4020022.
Results Reference
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PubMed Identifier
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Citation
National Collaborating Centre for Primary Care (UK). Low Back Pain: Early Management of Persistent Non-specific Low Back Pain [Internet]. London: Royal College of General Practitioners (UK); 2009 May. Available from http://www.ncbi.nlm.nih.gov/books/NBK11702/
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Citation
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Results Reference
derived

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

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