Therapy Exercises and Physiotherapy Delivered Operant Conditioning in the Treatment Chronic Low Back Pain
NCT ID: NCT04023162
Last Updated: 2022-03-07
Study Results
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Basic Information
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COMPLETED
NA
180 participants
INTERVENTIONAL
2019-07-22
2020-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Biomedical (Physiotherapy) group
Therapy Exercise and Back School; 8 sessions during 4 weeks (2 times a week), with one session lasting 60 min.
Group-based Therapy Exercise
Aerobic exercise, Stretching exercise and flexibility, Range of motion, Balance and coordination, Breathing exercises Stabilization exercise Muscle strength training exercise
Back School
Basic information of Low Back Pain - anatomy, physiology, causes, treatment. Correct postures - standing, sitting, driving, sleeping, Correct body movements - lifting, pushing, walking.
Biopsychosocial (Graded Activity) group
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.
Graded Activity
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.
Group-based Therapy Exercise
Aerobic exercise, Stretching exercise and flexibility, Range of motion, Balance and coordination, Breathing exercises Stabilization exercise Muscle strength training exercise
Back School
Basic information of Low Back Pain - anatomy, physiology, causes, treatment. Correct postures - standing, sitting, driving, sleeping, Correct body movements - lifting, pushing, walking.
Usual care
Usual care and written instructions on Therapy Exercise and Back School for self-care.
No interventions assigned to this group
Interventions
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Graded Activity
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.
Group-based Therapy Exercise
Aerobic exercise, Stretching exercise and flexibility, Range of motion, Balance and coordination, Breathing exercises Stabilization exercise Muscle strength training exercise
Back School
Basic information of Low Back Pain - anatomy, physiology, causes, treatment. Correct postures - standing, sitting, driving, sleeping, Correct body movements - lifting, pushing, walking.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age from 18 to 75 years of life,
* Both sexes.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Antonija Hrkać
OTHER
Responsible Party
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Antonija Hrkać
Master of Physiotherapy, Postgraduate Study in Health Sciences
Principal Investigators
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Antonija Hrkać
Role: PRINCIPAL_INVESTIGATOR
Faculty of Health Science
Locations
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Dom zdravlja Mostar
Mostar, , Bosnia and Herzegovina
Rehabilitacijski centar "Život"
Mostar, , Bosnia and Herzegovina
Countries
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References
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Ma VY, Chan L, Carruthers KJ. Incidence, prevalence, costs, and impact on disability of common conditions requiring rehabilitation in the United States: stroke, spinal cord injury, traumatic brain injury, multiple sclerosis, osteoarthritis, rheumatoid arthritis, limb loss, and back pain. Arch Phys Med Rehabil. 2014 May;95(5):986-995.e1. doi: 10.1016/j.apmr.2013.10.032. Epub 2014 Jan 21.
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.
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.
Hall A, Richmond H, Copsey B, Hansen Z, Williamson E, Jones G, Fordham B, Cooper Z, Lamb S. Physiotherapist-delivered cognitive-behavioural interventions are effective for low back pain, but can they be replicated in clinical practice? A systematic review. Disabil Rehabil. 2018 Jan;40(1):1-9. doi: 10.1080/09638288.2016.1236155. Epub 2016 Nov 21.
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.
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.
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/
Searle A, Spink M, Ho A, Chuter V. Exercise interventions for the treatment of chronic low back pain: a systematic review and meta-analysis of randomised controlled trials. Clin Rehabil. 2015 Dec;29(12):1155-67. doi: 10.1177/0269215515570379. Epub 2015 Feb 13.
Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
Hrkac A, Bilic D, Cerny-Obrdalj E, Baketaric I, Puljak L. Comparison of supervised exercise therapy with or without biopsychosocial approach for chronic nonspecific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2022 Nov 8;23(1):966. doi: 10.1186/s12891-022-05908-3.
Other Identifiers
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Studija I
Identifier Type: -
Identifier Source: org_study_id
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