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Chronic Nonspecific Low Back PainNCT04023162

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

A study testing Graded Activity, Group-based Therapy Exercise and Back School in people with Chronic Nonspecific Low Back Pain, run by Antonija Hrkać at 2 sites in Bosnia and Herzegovina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Chronic Nonspecific Low Back Pain
What is being tested?
Graded Activity, Group-based Therapy Exercise and Back School
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
2 sitesBosnia and Herzegovina
Study dates
22 Jul 2019to 30 Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Bosnia and Herzegovina2 sites

  • Dom zdravlja Mostar

    Mostar, 88000

  • Rehabilitacijski centar "Život"

    Mostar, 88000

Other trials in Bosnia and Herzegovina

About this study

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

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.

Read the 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.
Being tested
Graded Activity, Group-based Therapy Exercise, Back School
Keywords
Low Back Pain, Nonspecific, Operant Conditioning, Graded Activity, Therapy Exercise
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Graded ActivityBehavioural

    Also called Physiotherapy - Provided Operant Conditioning

    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 ExerciseBehavioural

    Also called Exercises Therapy, Kinesitherapy

    Aerobic exercise, Stretching exercise and flexibility, Range of motion, Balance and coordination, Breathing exercises Stabilization exercise Muscle strength training exercise

  • Back SchoolBehavioural

    Basic information of Low Back Pain - anatomy, physiology, causes, treatment. Correct postures - standing, sitting, driving, sleeping, Correct body movements - lifting, pushing, walking.

Study groups in NCT04023162
Study groupRoleWhat they receive
Biomedical (Physiotherapy) groupExperimentalTherapy Exercise and Back School; 8 sessions during 4 weeks (2 times a week), with one session lasting 60 min.
Receives: Behavioral: Group-based Therapy Exercise; Behavioral: Back School
Biopsychosocial (Graded Activity) groupExperimentalOperant Conditioning implement in Physiotherapy, Therapy Exercises and Back School; 8 sessions during 4 weeks (2 times a week), with one session lasting 60 min.
Receives: Behavioral: Graded Activity; Behavioral: Group-based Therapy Exercise; Behavioral: Back School
Usual careNo interventionUsual care and written instructions on Therapy Exercise and Back School for self-care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization

Secondary outcomes (8)

  1. 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.

    Measured: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization

  2. 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;

    Measured: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization

  3. 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.

    Measured: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization

  4. Change in Prone Double Straight Leg Raise Test (PDSLRT) Score

    Assessment of muscle strength back extensors, measures are in seconds.

    Measured: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization

  5. 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.

    Measured: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization

  6. 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.

    Measured: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization

  7. 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).

    Measured: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization

  8. 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.

    Measured: 6 month post-randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2019
  2. Study start22 Jul 2019
  3. Primary completion28 Feb 2020
  4. Study completion30 Apr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04023162
Sponsor's protocol ID
Studija I
Status last verified
Jul 2019
First submitted
14 Jul 2019
Last updated
7 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of individual participant data collected during the trial, after deidentification.

Publications

  • 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.

    PubMed 24462839

  • 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.

    PubMed 27712027

  • 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.

    PubMed 20614428

  • 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.

    PubMed 27871193

  • 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.

    PubMed 20189241

  • 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.

    PubMed 27417610

  • 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/

    PubMed 20704057

  • 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.

    PubMed 25681408

  • 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.

    PubMed 21982256

  • 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.

    PubMed 36348309

Questions about this trial

What is this clinical trial studying?

A study testing Graded Activity, Group-based Therapy Exercise and Back School in people with Chronic Nonspecific Low Back Pain, run by Antonija Hrkać at 2 sites in Bosnia and Herzegovina.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Bosnia and Herzegovina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Visual Analog Scale (VAS) Pain Score (time frame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04023162, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.

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