NCT06634511

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

October 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 8, 2024

Last Update Submit

October 8, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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,

    1 month

  • 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

    1 month

  • 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.

    1 month

Secondary Outcomes (1)

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

    1 month

Study Arms (3)

Core stability exercise group

EXPERIMENTAL

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

aerobic exercise group

EXPERIMENTAL

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

traditional physical therapy group

EXPERIMENTAL

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

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
Core stability exercise groupaerobic exercise grouptraditional physical therapy group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jouf university

Qurayyat, Jouf, Saudi Arabia

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor of physical therapy

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 10, 2024

Study Start

October 15, 2024

Primary Completion

December 30, 2024

Study Completion

April 30, 2025

Last Updated

October 10, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations