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

February 18, 2022 updated by: Antonija Hrkać

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bosnia and Herzegovina
      • Mostar, Bosnia and Herzegovina, 88000
        • Dom zdravlja Mostar
      • Mostar, Bosnia and Herzegovina, 88000
        • Rehabilitacijski centar "Život"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biomedical (Physiotherapy) group
Therapy Exercise and Back School; 8 sessions during 4 weeks (2 times a week), with one session lasting 60 min.
Behavioral: Group-based Therapy Exercise
Aerobic exercise, Stretching exercise and flexibility, Range of motion, Balance and coordination, Breathing exercises Stabilization exercise Muscle strength training exercise
Other Names:
  • Exercises Therapy, Kinesitherapy
Behavioral: Back School
Basic information of Low Back Pain - anatomy, physiology, causes, treatment. Correct postures - standing, sitting, driving, sleeping, Correct body movements - lifting, pushing, walking.
Experimental: 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.
Behavioral: Group-based Therapy Exercise
Aerobic exercise, Stretching exercise and flexibility, Range of motion, Balance and coordination, Breathing exercises Stabilization exercise Muscle strength training exercise
Other Names:
  • Exercises Therapy, Kinesitherapy
Behavioral: Back School
Basic information of Low Back Pain - anatomy, physiology, causes, treatment. Correct postures - standing, sitting, driving, sleeping, Correct body movements - lifting, pushing, walking.
Behavioral: 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.
Other Names:
  • Physiotherapy - Provided Operant Conditioning
No Intervention: Usual care
Usual care and written instructions on Therapy Exercise and Back School for self-care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Analog Scale (VAS) Pain Score
Time Frame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Self-reported pain intensity, Each item scored 0-100 mm (0=No pain; 100=Pain as bad as can be).
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Roland Morris Disability Questionnaire (RMDQ) Score
Time Frame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
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.
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Change in Goniometry of spine (ROM) Score
Time Frame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Functional assessment of range of motion in lumbal spine with goniometer - flexion, extension and latero-flexion right and left;
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Change in Finger to Floor Test (FTF)
Time Frame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Functional assessment of lumbar spine flexion; with a centimeters band the distance between the middle finger and the floor is measured.
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Change in Prone Double Straight Leg Raise Test (PDSLRT) Score
Time Frame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Assessment of muscle strength back extensors, measures are in seconds.
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Change in Hospital Anxiety and Depression Scale (HAD) Score
Time Frame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
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.
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Change in Fear-Avoidance Beliefs Questionnaire (FABQ) Score
Time Frame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
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.
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Change in Short Form Health Survey 12 (SF-12) core
Time Frame: Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
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).
Baseline, 4 week (post-treatment), 3 month i 6 month post-randomization
Questionnaire assessment of satisfaction with treatment
Time Frame: 6 month post-randomization
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.
6 month post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Antonija Hrkać

Investigators

  • Principal Investigator: Antonija Hrkać, Faculty of Health Science

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2019

Primary Completion (Actual)

February 28, 2020

Study Completion (Actual)

April 30, 2020

Study Registration Dates

First Submitted

July 14, 2019

First Submitted That Met QC Criteria

July 16, 2019

First Posted (Actual)

July 17, 2019

Study Record Updates

Last Update Posted (Actual)

March 7, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Studija I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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