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

NCT05921032 | Completed

• 1 other identifier: USM/JEPeM/19100637
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Nurses

Keywords

Kinematics; Kinetics; Human health; Spine

Outcome Measures

Primary Outcomes (13)

• Change in lumbar angle from baseline to post-intervention

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

  through study completion, an average of 4 months

• 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

  through study completion, an average of 4 months

• Change in hip angle from baseline to post-intervention

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

  through study completion, an average of 4 months

• Change in knee angle from baseline to post-intervention

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

  through study completion, an average of 4 months

• Change in ankle angle from baseline to post-intervention

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

  through study completion, an average of 4 months

• 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

  through study completion, an average of 4 months

• 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).

  through study completion, an average of 4 months

• 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.

  through study completion, an average of 4 months

• 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.

  through study completion, an average of 4 months

• 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.

  through study completion, an average of 4 months

• 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

  through study completion, an average of 4 months

• 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

  through study completion, an average of 4 months

• 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

  through study completion, an average of 4 months

Study Arms (3)

Lumbar stabilisation exercise (LSE)

OTHER

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

Lumbar muscle strengthening exercise (LMSE)

OTHER

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

Control group

NO INTERVENTION

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.

Interventions

Exercise intervention OTHER

8 weeks of exercise with two session in a week

Lumbar muscle strengthening exercise (LMSE); Lumbar stabilisation exercise (LSE)

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Sains Malaysia: lead

Study Sites (1)

Universiti Sains Malaysia Kampus Kesihatan

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Related Publications (2)

• 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.

  PMID: 23525973 BACKGROUND

• 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.

  PMID: 31923778 BACKGROUND

Study Officials

• Shazlin Shaharudin, PhD

  Universiti Sains Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Iinvestigator

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: June 27, 2023
• Study Start: May 1, 2023
• Primary Completion: August 31, 2023
• Study Completion: September 30, 2023
• Last Updated: December 24, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)