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Active Break Intervention on Low Back Pain and Musculoskeletal Discomfort During Prolonged Sitting Among Young People

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Active break with the proposed lumbar and hip extension exercises
Self-care recommendations
Sponsored by
Józef Piłsudski University of Physical Education
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring non-specific low back pain, young people, sitting position, break, active break

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 18 to 25 years of age; participants with non-specific low back pain (defined as pain and discomfort localized below the costal margin and above the inferior gluteal folds), pain of at least 3 months' duration, without radiation to legs; participants who did not have a surgical history due to spinal problems; participants who did not have radiculopathy or other injuries such as fractures, stenosis or tumors in the spine; participants who had not received any treatment related to low back within the last six months; participants who had not used medication for low back pain in the last three months. Exclusion Criteria: spinal pathology (eg, tumor, infection, fracture, inflammatory disease), patients with disc herniation and leg length discrepancy; pregnancy, nerve root compromise, previous spinal surgery, major surgery scheduled during treatment or follow-up period, presence of any contraindication to exercise.

Sites / Locations

  • Jozef Pilsudski University of Physical Education in Warsaw, Faculty of Physical Education and Heath in Biala Podlaska

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

Participants assigned to the experimental group will receive recommendation to take an active break with the proposed lumbar and hip extension exercises for every 30 minutes of sitting.

Participants assigned to the control group will receive an self-care recommendations book.

Outcomes

Primary Outcome Measures

Pain Intensity
Pain will be measured through Visual Analogue Scale (VAS, in centimeters). 0 represents "no pain" and 10 "worst pain possible".
Disability
Level of functional disabilities of participants resulting from LBP would be measured using Revised Oswestry Low Back Pain Disability Index
Perceived musculoskeletal discomfort during prolonged sitting
Perceived musculoskeletal discomfort during prolonged sitting will be measured using the Borg CR-10 scale during the 1 hour of sitting. Participants will indicate which parts of their body experienced musculoskeletal discomfort and how much discomfort was felt (on a scale of 0-10; 0 denotes no discomfort and 10 denotes extreme discomfort).
The Global Perceived Effect
The global perceived improvement will be assessed using The Global Perceived Effect Scale (GPE, 7-point numerical scale). The participants will be asked: 'Since the start of treatment, my current overall status is: 1 = completely recovered, 2 = much improved, 3 = slightly improved, 4 = not changed, 5 = slightly worsened, 6 = much worsened and 7 = worse than ever. These ratings will be dichotomized into "improved" (GPE scores 1-2) and "not improved" (GPE scores 3 to 7).

Secondary Outcome Measures

Post-Intervention Questionnaire
The postIQ will be focused on the subjective opinions of the participants in relation to the Active Break Program. The items will be presented in the form of statements to which students will be asked to respond using a 1-5 Likert scale ("strongly agree", "agree", "not sure", "disagree", and strongly disagree").

Full Information

First Posted
March 31, 2023
Last Updated
September 27, 2023
Sponsor
Józef Piłsudski University of Physical Education
Collaborators
University of Tehran
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1. Study Identification

Unique Protocol Identification Number
NCT05810519
Brief Title
Active Break Intervention on Low Back Pain and Musculoskeletal Discomfort During Prolonged Sitting Among Young People
Official Title
The Effect of an Active Break Intervention on Nonspecific Low Back Pain and Musculoskeletal Discomfort During Prolonged Sitting Among Young People (SPINE-have&Care)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
April 4, 2023 (Actual)
Primary Completion Date
July 1, 2023 (Actual)
Study Completion Date
July 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Józef Piłsudski University of Physical Education
Collaborators
University of Tehran

4. Oversight

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

5. Study Description

Brief Summary
The most recent evidence showed that the COVID-19 (coronavirus disease 2019, National Institutes of Health) pandemic caused an increase in low back pain (LBP) prevalence and intensity among young people. This may be explained by the prolonged sitting time, next to reduced level of physical activity. Young people spend most of their time in a sitting position while studying (in school class, during homework) and using electronic devices (using the computer, laptop, mobile phone, tablets, or watching TV), and now using e-learning methods. E-learning, and thus prolonged sitting, is a topic that returned to higher education at the beginning of the 2022-2023 academic year because of the current energy crisis. Re-education on sitting posture is a common aspect of LBP management. Physiotherapists recommend many different sitting positions to prevent and treat the negative effects of prolonged sitting. However, there is debate regarding what is an optimal sitting posture. Studies showed that sitting posture with the backrest on the chair induced minimal changes in lumbar lordosis and significantly lesser pain compared to other types of the chair. Even though the sitting posture will be followed by proper ergonomic principles, every position (lordotic or kyphotic) maintained for a prolonged time leads to discomfort and soft tissue symptoms. Studies showed that body perceived discomfort scores increased over time during sitting and after 30 min of sitting is significantly greater than those at baseline. Currently, breaks are recommended for mitigating the adverse of prolonged sitting, but more evidence is needed to verify effectiveness of breaks. The aim of this study is to evaluate the effect of active break on reduce LBP and perceived musculoskeletal discomfort during prolonged sitting in young people with LBP. Optimal combination of sitting and breaks will help to develop ergonomic recommendations for young people. Main research outcomes - exercise protocol and intervention - will be developed to match the needs of young people with LBP and the possibilities of the environment, in order to reduce LBP and musculoskeletal discomfort during prolonged sitting, and consequently, maintain health and quality of life. The intervention will address the social and health needs of a particular social group: young people, with the possibility of extending the recommendations to other groups.
Detailed Description
Background: Young people tend to spend most of their time in sitting position while studying (in the school class, during homework) and using the electronic devices (using the computer, laptop, mobile phone, tablets or watching TV). Moreover, during the COVID-19 (coronavirus disease 2019, National Institutes of Health) pandemic, many countries switched their teaching programs into e-learning, where students spend long hour using electronic devices. Now e-learning methods have been often used, not only during pandemic. The current energy crisis, exacerbated by the war in Ukraine, is causing e-learning back to educational institutions. However this change in learning methods is associated with musculoskeletal dysfunction including low back pain (LBP). Low back pain was one of the most common musculoskeletal disorders and today it is known that the COVID-19 pandemic has increased the prevalence and intensity of LBP. This may be explained by the prolonged sitting time, next to reduced level of physical activity. Most people sit for a long hours in a slumped sitting posture. Prolonged sitting causes changes in the passive structures of the spine and induces a low back compressive load significantly higher than that observed in standing. Physiotherapists recommend many different sitting positions to prevent and treat negative effects of prolonged sitting. However, there is debate regarding what is an optimal sitting posture. Periodic rest breaks have been identified as a way to reduce self-report discomfort at the low back and a standing breaks may be beneficial for the passive tissues of the spine. A combination of sitting and standing is beneficial for reducing musculoskeletal discomfort. Research aim: The aim of this study is to evaluate the effect of active break on reduce LBP and perceived musculoskeletal discomfort during prolonged sitting in young people with LBP. Methods: This will be a randomized controlled study with pre and post-intervention assessment. The participants will be recruited from students. Participants were randomly assigned to the intervention group consisting of an active break (n = 25) or the control group (n = 25). The group with an active break with postural change from sitting to standing will be recommended to take an active break for every 30 minutes of sitting. The primary outcome will be average pain intensity (Visual Analogue Scale, VAS), disability measured using the Oswestry Disability Index and perceived musculoskeletal discomfort during prolonged sitting (Borg scale) and The Global Perceived Effect (7-point Likert scale). Secondary outcome will Post-Intervention Questionnaire (5-item self-completed questionnaire). Expected outcomes: Research outcomes - exercise protocol and intervention - will be developed to match the needs of young people with LBP and the possibilities of the environment, in order to reduce LBP and musculoskeletal discomfort during prolonged sitting, and consequently, maintain health and quality of life. The intervention will address the social and health needs of a particular social group: young people, with the possibility of extending the recommendations to other groups. Research outcomes will build evidence-based practice for students, teachers, health professionals, personal trainers, and family doctors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
non-specific low back pain, young people, sitting position, break, active break

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Participants assigned to the experimental group will receive recommendation to take an active break with the proposed lumbar and hip extension exercises for every 30 minutes of sitting.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Participants assigned to the control group will receive an self-care recommendations book.
Intervention Type
Behavioral
Intervention Name(s)
Active break with the proposed lumbar and hip extension exercises
Intervention Description
Participants assigned to the experimental group will receive recommendation to take an active break with the proposed lumbar and hip extension exercises for every 30 minutes of sitting. In the experimental intervention, the exercise program include exercises and will be based on patient education. The participants will also explain the importance of regular training and receive a booklet with photographed and described exercises.
Intervention Type
Behavioral
Intervention Name(s)
Self-care recommendations
Intervention Description
Participants assigned to the control group will receive an educational self-care book containing information on low back pain, anatomy of the spine and its relation to the muscular chain, care during daily life activities and the importance of regular physical exercises. The control group will perform their regular baseline activities.
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Pain will be measured through Visual Analogue Scale (VAS, in centimeters). 0 represents "no pain" and 10 "worst pain possible".
Time Frame
Change from Pre-Intervention (baseline) compared to Post-Intervention (12 weeks)
Title
Disability
Description
Level of functional disabilities of participants resulting from LBP would be measured using Revised Oswestry Low Back Pain Disability Index
Time Frame
Change from Pre-Intervention (baseline) compared to Post-Intervention (12 weeks)
Title
Perceived musculoskeletal discomfort during prolonged sitting
Description
Perceived musculoskeletal discomfort during prolonged sitting will be measured using the Borg CR-10 scale during the 1 hour of sitting. Participants will indicate which parts of their body experienced musculoskeletal discomfort and how much discomfort was felt (on a scale of 0-10; 0 denotes no discomfort and 10 denotes extreme discomfort).
Time Frame
Change from Pre-Intervention (baseline) compared to Post-Intervention (12 weeks)
Title
The Global Perceived Effect
Description
The global perceived improvement will be assessed using The Global Perceived Effect Scale (GPE, 7-point numerical scale). The participants will be asked: 'Since the start of treatment, my current overall status is: 1 = completely recovered, 2 = much improved, 3 = slightly improved, 4 = not changed, 5 = slightly worsened, 6 = much worsened and 7 = worse than ever. These ratings will be dichotomized into "improved" (GPE scores 1-2) and "not improved" (GPE scores 3 to 7).
Time Frame
Completion of 12 week intervention
Secondary Outcome Measure Information:
Title
Post-Intervention Questionnaire
Description
The postIQ will be focused on the subjective opinions of the participants in relation to the Active Break Program. The items will be presented in the form of statements to which students will be asked to respond using a 1-5 Likert scale ("strongly agree", "agree", "not sure", "disagree", and strongly disagree").
Time Frame
Completion of 12 week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 to 25 years of age; participants with non-specific low back pain (defined as pain and discomfort localized below the costal margin and above the inferior gluteal folds), pain of at least 3 months' duration, without radiation to legs; participants who did not have a surgical history due to spinal problems; participants who did not have radiculopathy or other injuries such as fractures, stenosis or tumors in the spine; participants who had not received any treatment related to low back within the last six months; participants who had not used medication for low back pain in the last three months. Exclusion Criteria: spinal pathology (eg, tumor, infection, fracture, inflammatory disease), patients with disc herniation and leg length discrepancy; pregnancy, nerve root compromise, previous spinal surgery, major surgery scheduled during treatment or follow-up period, presence of any contraindication to exercise.
Facility Information:
Facility Name
Jozef Pilsudski University of Physical Education in Warsaw, Faculty of Physical Education and Heath in Biala Podlaska
City
Biala Podlaska
ZIP/Postal Code
21-500
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Active Break Intervention on Low Back Pain and Musculoskeletal Discomfort During Prolonged Sitting Among Young People

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