Clinical trial NCT05921032: Comparison of Biomechanics, Function and Pain and Effects of Exercise Intervention Among Nurses
Official title: Low Back Pain Among Nurses: Comparison of Biomechanics, Function and Pain Across Subtypes and Effects of Exercise Intervention.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nurses
Keywords: Kinematics
Kinetics
Human health
Spine
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 54
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: * 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in lumbar angle from baseline to post-intervention
timeFrame: through study completion, an average of 4 months
measure: Change in pelvic tilt angle from baseline to post-intervention
timeFrame: through study completion, an average of 4 months
measure: Change in hip angle from baseline to post-intervention
timeFrame: through study completion, an average of 4 months
measure: Change in knee angle from baseline to post-intervention
timeFrame: through study completion, an average of 4 months
measure: Change in ankle angle from baseline to post-intervention
timeFrame: through study completion, an average of 4 months
measure: Change in back extensor muscle power from baseline to post-intervention
timeFrame: through study completion, an average of 4 months
measure: Change in functional disability from baseline to post-intervention
timeFrame: through study completion, an average of 4 months
measure: Change in pain intensity from baseline to post-intervention
timeFrame: through study completion, an average of 4 months
measure: Change in endurance of trunk muscles from baseline to post-intervention
timeFrame: through study completion, an average of 4 months
measure: Change in hamstrings flexibility from baseline to post-intervention
timeFrame: through study completion, an average of 4 months
measure: Change in full body gravitational reaction force from baseline to post-intervention
timeFrame: through study completion, an average of 4 months
measure: Change in full body moment from baseline to post-intervention
timeFrame: through study completion, an average of 4 months
measure: Change in full body center of pressure from baseline to post-intervention
timeFrame: through study completion, an average of 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kubang Kerian
country: Malaysia
facility: Universiti Sains Malaysia Kampus Kesihatan
state: Kelantan
Study officials:
affiliation: Universiti Sains Malaysia
name: Shazlin Shaharudin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moon HJ, Choi KH, Kim DH, Kim HJ, Cho YK, Lee KH, Kim JH, Choi YJ. Effect of lumbar stabilization and dynamic lumbar strengthening exercises in patients with chronic low back pain. Ann Rehabil Med. 2013 Feb;37(1):110-7. doi: 10.5535/arm.2013.37.1.110. Epub 2013 Feb 28.
citation: Sipaviciene S, Kliziene I. Effect of different exercise programs on non-specific chronic low back pain and disability in people who perform sedentary work. Clin Biomech (Bristol). 2020 Mar;73:17-27. doi: 10.1016/j.clinbiomech.2019.12.028. Epub 2020 Jan 3.