Low Back PainNCT05810519
Active Break Intervention on Low Back Pain and Musculoskeletal Discomfort During Prolonged Sitting Among Young People
A study testing Active break with the proposed lumbar and hip extension exercises and Self-care recommendations in people with Low Back Pain, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Active break with the proposed lumbar and hip extension exercises and Self-care recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 sitePoland
- Study dates
- 4 Apr 2023to 3 Jul 2023
- 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 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Jozef Pilsudski University of Physical Education in Warsaw, Faculty of Physical Education and Heath in Biala Podlaska
Biała Podlaska, 21-500
About this study
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)
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Active break with the proposed lumbar and hip extension exercises, Self-care recommendations
- Keywords
- non-specific low back pain, young people, sitting position, break, active break
- 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.
Active break with the proposed lumbar and hip extension exercisesBehavioural
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.
Self-care recommendationsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Behavioral: Active break with the proposed lumbar and hip extension exercises |
| Control group | Active comparator | Participants assigned to the control group will receive an self-care recommendations book. Receives: Behavioral: Self-care recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Pain will be measured through Visual Analogue Scale (VAS, in centimeters). 0 represents "no pain" and 10 "worst pain possible".
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (12 weeks)
Disability
Level of functional disabilities of participants resulting from LBP would be measured using Revised Oswestry Low Back Pain Disability Index
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (12 weeks)
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).
Measured: Change from Pre-Intervention (baseline) compared to Post-Intervention (12 weeks)
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).
Measured: Completion of 12 week intervention
Secondary outcomes (1)
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").
Measured: Completion of 12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start4 Apr 2023
- Primary completion1 Jul 2023
- Study completion3 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Józef Piłsudski University of Physical Education
- Sponsor type
- University, hospital or other
- Collaborators
- University of Tehran
- Responsible party
- Principal investigator, Magdalena Plandowska, Józef Piłsudski University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810519
- Sponsor's protocol ID
- 3/BN/UPB/2023
- Status last verified
- Sep 2023
- First submitted
- 31 Mar 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Plandowska M, Labecka MK, Truszczynska-Baszak A, Plaszewski M, Rajabi R, Makaruk B, Rozanska D. The Effect of an Active Break Intervention on Nonspecific Low Back Pain and Musculoskeletal Discomfort during Prolonged Sitting among Young People-Protocol for a Randomized Controlled Trial. J Clin Med. 2024 Jan 22;13(2):612. doi: 10.3390/jcm13020612.
PubMed 38276118Labecka MK, Plandowska M, Truszczynska-Baszak A, Rajabi R, Rozanska D, Plaszewski M. Effects of the active break intervention on nonspecific low back pain among young people: a randomized controlled trial. BMC Musculoskelet Disord. 2024 Dec 20;25(1):1055. doi: 10.1186/s12891-024-08186-3.
PubMed 39707287
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05810519
- Acronym / sponsor ID
- 3/BN/UPB/2023
- Conditions
- Low Back Pain
- Keywords
- non-specific low back pain, young people, sitting position, break, active break
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Józef Piłsudski University of Physical EducationUniversity, hospital or other
- Collaborators
- University of Tehran
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 3 Jul 2023 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Active break with the proposed lumbar and hip extension exercisesParticipants 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. |
| Control group | Active comparator | Behavioral: Self-care recommendationsParticipants assigned to the control group will receive an self-care recommendations book. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (7 listed)
- spinal pathology (eg, tumor, infection, fracture, inflammatory disease),
- patients with disc herniation and leg length discrepancy;
- pregnancy,
- nerve root compromise,
- previous spinal surgery,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active break with the proposed lumbar and hip extension exercisesParticipants 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. | Behavioural | Experimental group |
| Self-care recommendationsParticipants 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. | Behavioural | Control group |
Primary outcome
Pain Intensity
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (12 weeks)
Pain will be measured through Visual Analogue Scale (VAS, in centimeters). 0 represents "no pain" and 10 "worst pain possible".
Disability
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (12 weeks)
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
Time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (12 weeks)
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
Time frame: Completion of 12 week intervention
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).
1 secondary outcome
Post-Intervention Questionnaire
Time frame: Completion of 12 week intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 38276118Plandowska M, Labecka MK, Truszczynska-Baszak A, Plaszewski M, Rajabi R, Makaruk B, Rozanska D. The Effect of an Active Break Intervention on Nonspecific Low Back Pain and Musculoskeletal Discomfort during Prolonged Sitting among Young People-Protocol for a Randomized Controlled Trial. J Clin Med. 2024 Jan 22;13(2):612. doi: 10.3390/jcm13020612.
- Derived from this study: PubMed 39707287Labecka MK, Plandowska M, Truszczynska-Baszak A, Rajabi R, Rozanska D, Plaszewski M. Effects of the active break intervention on nonspecific low back pain among young people: a randomized controlled trial. BMC Musculoskelet Disord. 2024 Dec 20;25(1):1055. doi: 10.1186/s12891-024-08186-3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active break with the proposed lumbar and hip extension exercises and Self-care recommendations in people with Low Back Pain, run by Józef Piłsudski University of Physical Education at 1 site in Poland.
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 6 inclusion and 7 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 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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?
Pain Intensity (time frame: Change from Pre-Intervention (baseline) compared to Post-Intervention (12 weeks)). The study lists 4 primary outcomes in all. 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 NCT05810519, which also lists 2 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 30 Jan 2024.