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NursesNCT05921032

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

A study testing Exercise intervention in people with Nurses, run by Universiti Sains Malaysia at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 20 to 55 years, women only
Conditions the study is for
Nurses
What is being tested?
Exercise intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteMalaysia
Study dates
1 May 2023to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 55 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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
Show all 14Show fewer
  • 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 locations and contacts

1 site in 1 country.

Malaysia1 site

  • Universiti Sains Malaysia Kampus Kesihatan

    Kubang Kerian, Kelantan, 16150

Other trials in Malaysia

About this study

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

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?
Read more

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.

Read the 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.
Conditions
Nurses
Keywords
Kinematics, Kinetics, Human health, Spine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05921032
Study groupRoleWhat they receive
Lumbar stabilisation exercise (LSE)OtherLumbar 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.
Receives: Other: Exercise intervention
Lumbar muscle strengthening exercise (LMSE)OtherLumbar 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.
Receives: Other: Exercise intervention
Control groupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: through study completion, an average of 4 months

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

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

    Measured: through study completion, an average of 4 months

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

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

    Measured: through study completion, an average of 4 months

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

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

    Measured: through study completion, an average of 4 months

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

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

    Measured: through study completion, an average of 4 months

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

    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

    Measured: through study completion, an average of 4 months

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

    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).

    Measured: through study completion, an average of 4 months

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

    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.

    Measured: through study completion, an average of 4 months

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

    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.

    Measured: through study completion, an average of 4 months

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

    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.

    Measured: through study completion, an average of 4 months

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

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

    Measured: through study completion, an average of 4 months

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

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

    Measured: through study completion, an average of 4 months

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

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

    Measured: through study completion, an average of 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2023
  2. Study start1 May 2023
  3. Primary completion31 Aug 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05921032
Sponsor's protocol ID
USM/JEPeM/19100637
Status last verified
Aug 2023
First submitted
3 Apr 2023
Last updated
24 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23525973

  • 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.

    PubMed 31923778

Questions about this trial

What is this clinical trial studying?

A study testing Exercise intervention in people with Nurses, run by Universiti Sains Malaysia at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in lumbar angle from baseline to post-intervention (time frame: through study completion, an average of 4 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05921032, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.

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