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Not yet recruitingNCT06634511Updated Oct 10, 2024

Core Stability Exercise Versus Aerobic Exercise on Pain, Range of Motion and Function in Patients With Chronic Mechanical Low Back Pain: Randomized Controlled Trial

An interventional study of core stability exercises in Patients With Chronic Mechanical LBP, sponsored by Cairo University. Not yet recruiting at 1 site in Saudi Arabia. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-10-10.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
Female
01

Study summary

Chronic mechanical low back pain (CMLBP) is a prevalent musculoskeletal condition characterized by persistent pain originating from the spine, muscles, ligaments, or intervertebral discs. It is one of the leading causes of disability worldwide. (CMLBP) have significantly affected the individual's physical, emotional, and social well-being, as well as their overall quality of life, functional capacity, and productivity of individuals. Unlike acute low back pain, which typically resolves within a few weeks, CMLBP persists for more than three months and often fluctuates in intensity, leading to recurrent episodes of pain and discomfort [1]. Chronic mechanical low back pain (LBP) has been the subject of extensive research, with numerous studies highlighting its multifactorial nature and varied treatment outcomes. Previous research has established that chronic mechanical LBP often results from prolonged strain on the lumbar spine due to poor posture, repetitive stress, or underlying musculoskeletal imbalances. Studies have consistently shown that interventions such as physical therapy, which includes strengthening exercises and ergonomic adjustments, can be effective in alleviating symptoms and improving functional outcomes.

However, evidence also suggests that the efficacy of these treatments can be limited by factors such as patient adherence and the presence of psychological components like anxiety and depression.

Furthermore, recent research emphasizes the importance of a multidisciplinary approach that integrates both physical and psychological therapies to address the complex nature of chronic mechanical LBP more comprehensively [2]. Aerobic exercise involves activities that increase the heart rate and improve cardiovascular endurance. The rationale for using aerobic exercise in the management of CMLBP is based on several physiological mechanisms. Firstly, aerobic exercise enhances blood ow and nutrient delivery to the spine and surrounding musculature, which can promote healing and reduce muscle stiffness.

Secondly, regular aerobic activity has been shown to reduce systemic inflammation and increase endorphin production, both of which can lower pain perception. Additionally, aerobic exercise can improve psychological well-being, which is an important factor given the strong association between chronic pain and mental health conditions like depression and anxiety [1]. Core stability training focuses on strengthening the muscles that support the spine, including the transversus abdominis, multifidus, pelvic floor muscles, and other muscles of the abdomen, lower back, and pelvis. These muscles play a critical role in maintaining spinal stability and proper alignment, which is essential for preventing and managing back pain. Core stability exercises, such as planks, bridges, and lumbar stabilization exercises, aim to enhance the endurance and coordination of these muscles, thereby reducing excessive spinal movements and mechanical strain that can exacerbate pain [3] Aerobic exercise and core stability training are commonly recommended for chronic mechanical low back pain (CMLBP). but to our knowledge, there is insufficient evidence comparing the relative effectiveness of aerobic exercise and core stability training, leaving a gap in understanding which approach provides superior outcomes for CMLBP. So the aim of our study is to compare between the effectiveness of aerobic exercise and core stability training on pain, range of motion, flexibility, and functional abilities in patients of CMLBP.

Read the detailed description

Study Design:

Randomized control trail study. 2.2. Study Area: Faculty of applied medical sciences, physiotherapy department at Jouf University 2.3. Study Population: We will include studies that evaluated patients over 18years of age and below 50 years with chronic non-specific low back pain defined as pain or discomfort lasting more than 12weeks in the region below the last costal margins and above the lower gluteal folds, without symptoms in the lower limbs [4].. 2.3.1. Inclusion Criteria: All females between 18-50 years have mechanical LBP more than 3 months 2.3.2. Exclusion Criteria: Patients will be excluded if they evaluated patients with nerve root compromise, metabolic or serious spinal pathologies (e.g., fractures, tumors, inflammatory, and infectious diseases), previous spinal surgery, postpartum low back pain or pelvic pain due to pregnancy, and pain unrelated to the lower back.

Assessment tools:

Numerical rating scale:

Pain Numeric Rating Scale (PNRS): The PNRS is a straightforward tool where patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain).

It provides a subjective measure of pain intensity and is widely used due to its simplicity and effectiveness in capturing a patient's perceived pain level, Pain scores were classified as follows: 0 (no pain), 1-3 (mild), 4-7 (moderate), and 8-10 (high) [5].

Range of Motion (ROM):

Lumber ROM will be assessed by A standard gravity-based inclinometer (model A-300; Vertex Co., Taiwan) for assessing flexion, extension and lateral bending

Modified modified schober test for assessment of lumber flexibility: Modified Modified Schober Test (MMST)is a modification of Modified Schober Test(MST) by Van Adrichen and Van der Korst(1973). It uses two marks one over the spine connecting two PSIS and other over 15 cm superior to first mark. It eliminates the errors in identification of lumbosacral junction and make sure that entire lumbarspine was included. [6]

The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluatorsFAIRS \& RESEARCH CENTER use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools [7].

02

Conditions studied

  • Patients With Chronic Mechanical LBP
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's planned enrollment of 45 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • All females between 18-45 years have mechanical LBP more than 3 months

Exclusion criteria

Exclusion Criteria:

  • Patients will be excluded if they evaluated patients with nerve root compromise, metabolic or serious spinal pathologies (e.g., fractures, tumors, inflammatory, and infectious diseases), previous spinal surgery, postpartum low back pain or pelvic pain due to pregnancy, and pain unrelated to the lower back.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Core stability exercise group

    Group A: core stability exercise group:15 Patients assigned to this group will undergo a core stability exercises.2times per week /8weeks.in addition to traditional physical therapy program

    Other: core stability exercises

  • Experimental
    aerobic exercise group

    Group B:(aerobic exercise group) 15 patients will receive aerobic exercise in the form of treadmill for 30 minutes2 session per week/8 weeks

    Other: core stability exercises

  • Experimental
    traditional physical therapy group

    Group C(conventional group): 15 patients will receive Infrared radiation (using BL 220 Infrared lamp, MT03009201 model) for 15 minutes, Transcutaneous Electrical Nerve stimulation (using model DX66053, pain modulation mode) for 10 minutes, Participants were treated twice weekly

    Other: core stability exercises

Interventions

  • Othercore stability exercises

    Group A: core stability exercise group:15 Patients assigned to this group will undergo a core stability exercises" ts.2times per week /8weeksin addition to conventional therapy (Infrared radiation (using BL 220 Infrared lamp, MT03009201 model) for 15 minutes, Transcutaneous Electrical Nerve stimulation (using model DX66053, pain modulation mode) for 10 minutes Group B:(aerobic exercise group) 15 patients will receive aerobic exercise in the form of treadmill for 30 minutes2 session per week/8 weeks Group C(conventional group): 15 patients will receive Infrared radiation (using BL 220 Infrared lamp, MT03009201 model) for 15 minutes, Transcutaneous Electrical Nerve stimulation (using model DX66053, pain modulation mode) for 10 minutes, Participants were treated twice weekly

    Also known as: aerobic exercise

06

What researchers measure

Primary outcomes

  1. Numerical rating scale:

    ain Numeric Rating Scale (PNRS): The PNRS is a straightforward tool where patients rate their pain on a scale from 0 (no pain) to 10 (worst possible pain). It provides a subjective measure of pain intensity and is widely used due to its simplicity and effectiveness in capturing a patient's perceived pain level,

    Time frame: 1 month

  2. Range of motion Range of Motion (ROM): Range of Motion (ROM):

    Lumber ROM will be assessed by A standard gravity-based inclinometer (model A-300; Vertex Co., Taiwan) for assessing flexion, extension and lateral bending

    Time frame: 1 month

  3. Modified modified schober test for assessment of lumber flexibility:

    Modified Modified Schober Test (MMST)is a modification of Modified Schober Test(MST) by Van Adrichen and Van der Korst(1973). It uses two marks one over the spine connecting two PSIS and other over 15 cm superior to first mark. It eliminates the errors in identification of lumbosacral junction and make sure that entire lumbarspine was included.

    Time frame: 1 month

Secondary outcomes

  1. The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire)

    The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools .

    Time frame: 1 month

07

Study locations

1 site
  • Jouf university
    Qurayyat, Jouf, Saudi Arabia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06634511
Lead sponsor
Cairo University
Responsible party
Zeinab Abd el fattah Ali (assistant professor of physical therapy, Cairo University) — Principal investigator
First posted
Oct 10, 2024
Start date
Oct 15, 2024 (estimated)
Primary completion
Dec 30, 2024 (estimated)
Completion
Apr 30, 2025 (estimated)
Last update
Oct 10, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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