Skip to main content
OpenTrials
Completed

NCT Number: NCT05921032

Comparison of Biomechanics, Function and Pain and Effects of Exercise Intervention Among Nurses

The goal of this study is to compare the effects of exercise interventions (lumbar stabilisation exercise (LSE) versus lumbar muscles strengthening exercises (LMSE)) on full body mechanics, functional disability outcomes and pain score among female nurses with chronic non-specific low back pain (CNLBP). The main questions are:

* What are the differences in full body mechanics, functional disability outcomes and pain score among female nurses with CNLBP? * How exercise intervention affects full body mechanics, functional disability outcomes and pain score among female nurses with CNLBP?

Participants will be divided into three groups (lumbar stabilisation exercise (LSE), lumbar muscles strengthening exercises (LMSE) and control group). Exercise intervention group will be asked to perform 8 weeks of exercise intervention with :

* 3D kinematics and trunk spinal loads test * Trunk muscle power (extensor) test * Sit-and-reach test * Functional disability (Roland-Morris Low Back Pain and Disability Questionnaire, RMQ) * Pain intensity (Visual analogue scale, VAS) * Endurance of trunk muscle test

Meanwhile control group will be given a diary to record their daily activities which consist of their 24 hours diet recall for 8 weeks and involvement of any physical activity throughout the 8 weeks.

Researchers will compare between two exercise groups to see if there is any differences in full body mechanics, functional disability outcomes and pain score across different among female nurses with CNLBP.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nurses

Age range

20 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universiti Sains Malaysia Kampus Kesihatan

Kubang Kerian, Kelantan, 16150, Malaysia

About this study

  • All participants are female nurses with age range between 20 - 55 years old from Hospital USM and have chronic LBP persisting for longer than three months.
  • Randomisation of participants' selection will be conducted using computer. The allocation numbers will be generated by the computer via excel formulas to get evenly distributed names into three groups.
  • The sample size is calculated using GPower software (v.3.1.9.7, Universität Düsseldorf, German) of Repeated Measure ANOVA with p value set at 0.05 and effect size is 0.75. Based on effect size, it showed that 15 participants per group are sufficient to yield 0.8 power of the study with four times of assessments (i.e., pre-intervention assessment, mid- intervention assessment, post- intervention assessment, and 1 month after intervention). By inclusion of 20% drop out rate a total of 54 participants were recruited with 18 participants per group (n=18).
  • Participants need to attend at least 75% of the training session and their data will not be evaluated if they do not meet this minimum adherence level.
  • All statistical analyses will be performed using Statistical Package for Social Science (SPSS) version 26.0 (IBM Inc., Armonk, New York, United States). The level of significance was set at p<0.05.All data will be tested for normal distribution via the Shapiro Wilk test. Repeated Measure ANOVA will be conducted to compare the lower extremity and trunk kinematics, endurance of trunk flexor and extensor muscles, functional disability, pain intensity values and anthropometric data across two groups at pre, middle, post and one month follow up after exercises intervention.
  • All 3D kinematics and trunk spinal loads test, trunk muscle power (extensor) test, sit-and-reach test, functional disability (Roland-Morris Low Back Pain and Disability Questionnaire, RMQ), pain intensity (Visual analogue scale, VAS) and endurance of trunk muscle test will be assessed during pre assessment, middle assessment (during fourth week of exercise intervention), post assessment and after one month follow up assessment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female nurses from Hospital USM
  • Had chronic non specific LBP persisting for longer than three months.
  • Treated as outpatients of HUSM

Exclusion criteria

  • history of cerebrovascular disease
  • chronic diseases that cause long-term immobilisation
  • history of previous spine surgery
  • diagnosed with spinal cord disease
  • history of rheumatic disease
  • diagnosed with cancer
  • history of neurological deficits
  • history of infectious and systemic disease
  • history of radicular pain due to nerve root involvement
  • history of structural lesion such as spondylosis
  • spondylolisthesis
  • scoliosis
  • kyphosis
  • vertebral bone fracture

Treatment and study plan

Exercise intervention

Other

8 weeks of exercise with two session in a week

Primary outcomes

  1. Change in lumbar angle from baseline to post-intervention

    Time frame: through study completion, an average of 4 months

    Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load

  2. Change in pelvic tilt angle from baseline to post-intervention

    Time frame: through study completion, an average of 4 months

    Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load

  3. Change in hip angle from baseline to post-intervention

    Time frame: through study completion, an average of 4 months

    Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load

  4. Change in knee angle from baseline to post-intervention

    Time frame: through study completion, an average of 4 months

    Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load

  5. Change in ankle angle from baseline to post-intervention

    Time frame: through study completion, an average of 4 months

    Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load

  6. Change in back extensor muscle power from baseline to post-intervention

    Time frame: through study completion, an average of 4 months

    Grading of muscle strength (Oxford Scale) will be used to assess back extensor muscle power. 0/5 = no muscle movement, 1/5 = muscle movement without joint motion, 2/5 = movement with gravity eliminated, 3/5 = movement against gravity but not against resistance, 4/5 = movement against gravity and light resistance and 5/5 represents normal strength

  7. Change in functional disability from baseline to post-intervention

    Time frame: through study completion, an average of 4 months

    Functional disability will be assessed by using the Roland-Morris Low Back Pain and Disability Questionnaire. Greater levels of disability are reflected by higher numbers of 24-point scale which represented 24 questions. Through analysis of serial questionnaire scores, a clinical improvement over time can be graded. For example, at the beginning of test, a participant's score was 10, and after test, her score was 2 (8 points of improvement). Therefore, the improvement percentage was 80% (8/10 x 100).

  8. Change in pain intensity from baseline to post-intervention

    Time frame: through study completion, an average of 4 months

    Visual analogue scale (VAS) will be used to assess the pain intensity. The minimum values "0" referring to no pain and maximum values "10" referring to worst imaginable pain.

  9. Change in endurance of trunk muscles from baseline to post-intervention

    Time frame: through study completion, an average of 4 months

    Trunk flexor muscle and extensor muscle will be tested according to the duration of the muscles contraction. Long time duration (more than 4 minutes) means the participant has no back pain.

  10. Change in hamstrings flexibility from baseline to post-intervention

    Time frame: through study completion, an average of 4 months

    Flexibility of the lower back and hamstrings will be assessed by using sit and reach test. The scale will be referring to The American College of Sports Medicine (ACSM) which range from excellent to poor (in cm) according to their age.

  11. Change in full body gravitational reaction force from baseline to post-intervention

    Time frame: through study completion, an average of 4 months

    Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load

  12. Change in full body moment from baseline to post-intervention

    Time frame: through study completion, an average of 4 months

    Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load

  13. Change in full body center of pressure from baseline to post-intervention

    Time frame: through study completion, an average of 4 months

    Biomechanical data measured during walking, sit-to-stand and carrying and transferring a standard load

Sponsors and collaborators

Lead sponsor

Universiti Sains Malaysia

Other

Registry information

Official study title

Low Back Pain Among Nurses: Comparison of Biomechanics, Function and Pain Across Subtypes and Effects of Exercise Intervention.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 27, 2023
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.