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

Universiti Sains Malaysia

Status: Completed

Conditions: Nurses

Treatments: Other: Exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05921032

USM/JEPeM/19100637

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: Female

Ages: 20 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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54 participants in 3 patient groups

Lumbar stabilisation exercise (LSE)

Other group

Description:

Lumbar stabilisation exercise (LSE) group will perform eight weeks exercise intervention for two sessions in a week. Each session took about 45 minutes to complete. The total exercise sessions were 16 sessions. LSE group will be focused on strengthening the deep trunk stabilising muscles (i.e., transverse abdominal, internal oblique and lumbar multifidus) and control pelvis muscles.

Treatment:

Other: Exercise intervention

Lumbar muscle strengthening exercise (LMSE)

Other group

Description:

Lumbar muscle strengthening exercise (LMSE) group will perform eight weeks exercise intervention for two sessions in a week. Each session took about 45 minutes to complete. The total exercise sessions were 16 sessions. LMSE group aims to strengthen the trunk flexor and extensor muscles.

Treatment:

Other: Exercise intervention

Control group

No Intervention group

Description:

The 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. This diary will be collected during follow up (1 month after post-intervention). Upon completion of the trial, participants in the control group will receive either LSE or LMSE or combination of both exercises depending on their preference.