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

NCT05810519 | Completed

• 1 other identifier: 3/BN/UPB/2023
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

non-specific low back pain; young people; sitting position; break; active break

Outcome Measures

Primary Outcomes (4)

• Pain Intensity

  Pain will be measured through Visual Analogue Scale (VAS, in centimeters). 0 represents "no pain" and 10 "worst pain possible".

  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

  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).

  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).

  Completion of 12 week intervention

Secondary Outcomes (1)

• Post-Intervention Questionnaire

  Completion of 12 week intervention

Study Arms (2)

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.

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.

Behavioral: Self-care recommendations

Interventions

Active break with the proposed lumbar and hip extension exercises BEHAVIORAL

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.

Experimental group

Self-care recommendations BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Józef Piłsudski University of Physical Education: lead
• University of Tehran: collaborator

Study Sites (1)

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

Biała Podlaska, 21-500, Poland

Location

Related Publications (2)

• 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.

  PMID: 38276118 BACKGROUND

• Labecka 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.

  PMID: 39707287 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: March 31, 2023
• First Posted: April 12, 2023
• Study Start: April 4, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 3, 2023
• Last Updated: January 30, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)