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

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ClinicalTrials.gov Identifier: NCT05921032
Recruitment Status : Active, not recruiting
First Posted : June 27, 2023
Last Update Posted : June 27, 2023
Sponsor:
Information provided by (Responsible Party):
Shazlin Shaharudin, Universiti Sains Malaysia

Study Description
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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.


Condition or disease Intervention/treatment Phase
Nurses Other: Exercise intervention Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Low Back Pain Among Nurses: Comparison of Biomechanics, Function and Pain Across Subtypes and Effects of Exercise Intervention.
Actual Study Start Date : January 17, 2021
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : September 30, 2023
Arms and Interventions
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Arm Intervention/treatment
Lumbar stabilisation exercise (LSE)
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.
 Other: Exercise intervention
8 weeks of exercise with two session in a week
Lumbar muscle strengthening exercise (LMSE)
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.
 Other: Exercise intervention
8 weeks of exercise with two session in a week
No Intervention: Control group
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.


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05921032


Locations
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Malaysia
Universiti Sains Malaysia Kampus Kesihatan
Kubang Kerian, Kelantan, Malaysia, 16150
Sponsors and Collaborators
Universiti Sains Malaysia
Investigators
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Principal Investigator: Shazlin Shaharudin, PhD Universiti Sains Malaysia
More Information
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Publications:

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Responsible Party: Shazlin Shaharudin, Principal Iinvestigator, Universiti Sains Malaysia
ClinicalTrials.gov Identifier: NCT05921032    
Other Study ID Numbers: USM/JEPeM/19100637
First Posted: June 27, 2023    Key Record Dates
Last Update Posted: June 27, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shazlin Shaharudin, Universiti Sains Malaysia:
Kinematics
Kinetics
Human health
Spine