A Suggested Functional Exercises Program For Patients With Chronic Mechanical Low Back Pain

The aim of this study will be to investigate the effect of functional exercise on pain, functional disability and core strength in patients with chronic mechanical low back pain .

Study Overview

• Status: Recruiting
• Conditions: Chronic Mechanical Low Back Pain
• Intervention / Treatment: Other: advices; Other: exercises plus advices

Detailed Description

To our knowledge, there has been not enough studies that investigated the effect of core strengthening by functional exercise on pain, functional disability and core muscle strength in patients with chronic mechanical low back pain. Therefore, this study may open up ways to other researchers to investigate and build up on this effect if present and address such an important issue.

the finding of this proposed work may help patients with chronic mechanical low back pain by addressing their pain, functional limitation, and/or participation restrictions. Consequently, this can speed up their recovery, return to work, decrease cost of treatment, improve psychological status, decrease level of irritability, and improve overall quality of life.

Patients with chronic mechanical low back pain will be recruited after approval of ethical committee of the faculty of physical therapy, Cairo University. All participants will sign a written informed consent form.

The subjects will be randomly assigned into one of two groups:

• Group I (control) will receive advices only.
• Group II (experimental) will receive a suggested functional exercise program plus advises.

the measurments will take before and after treatment programe .

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Doha Ali, master; Phone Number: 01019734952; Email: prinessoflight@gmail.com
• Study Contact Backup: Name: Mohamed Ahmed, Lecturer; Phone Number: 01223631604

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Cairo University
    • Contact: Doha Ali, master; Phone Number: 01019734952; Email: prinessoflight@gmail.com
    • Contact: Mohamed Ahmed, Lecturer; Phone Number: 01223631604

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Chronic mechanical low back pain and their age will be ranged from 20 -45 years.
• History of chronic low back pain (≥3 months).
• Patients with Body Mass Index (BMI) between 18-28

Exclusion Criteria:

• Age younger than 20 or older than 45 years of age.
• History of any surgical procedure in the back or the lower extremities
• Back pain secondary to known specific pathology (e.g. infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder (e.g. ankylosing spondylitis) or cauda equine syndrome).
• Patient with lumbar instability including spondylolisthesis.
• Red flags (e.g. fever, unexplained weight loss, progressive weakness, radiation to lower limb, bowel and bladder dysfunction).
• Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: advices; • Group I (control) will receive advices only.	Other: advices; The following advice will be given to the patients : Walking as flexibly (normally) as possible; Advise when lifting ;avoid twisting and bending.for heavy objects use thighs with a vertical back.at other times, use the back and flex it.; Heat application for 20 mins twice /day .; Avoid sitting or standing for prolonged period and change position every 15 mins.; Sitting: Sit with a back support; Driving: Use a back support (lumbar roll) at the curve of your back.; Sleeping and lying down: Select a firm mattress and box spring set that does not sag. If necessary, place a board under your mattress. You can also place the mattress on the floor temporarily if necessary.
Experimental: exercises plus advices; • Group II (experimental) will receive a suggested functional exercise program plus advises	Other: advices; The following advice will be given to the patients : Walking as flexibly (normally) as possible; Advise when lifting ;avoid twisting and bending.for heavy objects use thighs with a vertical back.at other times, use the back and flex it.; Heat application for 20 mins twice /day .; Avoid sitting or standing for prolonged period and change position every 15 mins.; Sitting: Sit with a back support; Driving: Use a back support (lumbar roll) at the curve of your back.; Sleeping and lying down: Select a firm mattress and box spring set that does not sag. If necessary, place a board under your mattress. You can also place the mattress on the floor temporarily if necessary.; Other: exercises plus advices; In addition to the same advice of group A, a suggested functional exercise will be performed for this group.; Sidestepping against band resistance:; The quadriped opposite arm leg aganist resistance .; Squat row on a balance board with band resistance:; Front raise single leg support with band resistance:; The Advanced Prone Bridge:; Side sliding on a fitter board (lateral lunge with band): Other Names: a suggested functional exercise program plus advises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain in lower back	will be measured by The Numeric Pain Rating Scale (NPRS). it consists of The 11-point numeric scale ranges from '0' representing one pain extreme (e.g., "no pain") to '10' representing the other pain extreme (e.g., "pain as bad as you can imagine" or "worst pain imaginable .patients are asked to indicate the point along the line that best reflect their pain intensity .	change from max pain point in 1 month
functional disability	will be measured by Arabic version of Oswestry Disability Index (ODI) is a self-reported questionnaire consisting of 10 questions related to back function . Each question is answered on a 6-item Likert scale and is scored from 0 (minimum degree of difficulty in that activity) to 5 (maximum degree of difficulty). These questions assess the activities of daily living in patients with LBP. The questions in the index include pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life and travelling. The validity of Arabic version of ODI is good intra-observer reliability was excellent . The correlations of the ODI with the VAS pain scale, the Roland-Morris Low Back Pain Disability and the Quebec Back Pain Disability.	change in 1 month
core muscles stability	The researcher will conduct a series of core stability tests before and after the core training program. Core stability tests has been reported to be highly reliable (ICC ≥ 0.98) and showed moderate to high correlation with one another (correation coefficient ranged from 0.4 to 0.8) , The following core tests will be used: trunk flexion test (McGill's test) , Trunk extension (Sorenson Test) , Side plank test and prone plank test .	change in 1 month
lower limb function	will measured by Functional assessment using one legged hops test The most commonly used functional tests are a series of one-legged hops described by Noyes et al. (1991). The sensitivity of the single (49%), triple (50%), crossover (58%), and timed (52%) hop tests were reported by Noyes et al. (1991). The specificity was 97% and 94% for the timed and single hops, respectively	change in 1 month

Collaborators and Investigators

• Sponsor: Doha Ali Amin Ahmed
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): November 1, 2024

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 7, 2023
• First Posted (Actual): May 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 16, 2023
• Last Update Submitted That Met QC Criteria: May 7, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: mechanical low back pain

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No