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

NCT05860218 | Unknown

• 1 other identifier: mechanical low back pain
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Chronic Mechanical Low Back Pain

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

advices

OTHER

• Group I (control) will receive advices only.

Other: advices

exercises plus advices

EXPERIMENTAL

• Group II (experimental) will receive a suggested functional exercise program plus advises

Other: advices; Other: exercises plus advices

Interventions

advices OTHER

The following advice will be given to the patients : 1. Walking as flexibly (normally) as possible 2. 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. 3. Heat application for 20 mins twice /day . 4. Avoid sitting or standing for prolonged period and change position every 15 mins. 5. Sitting: Sit with a back support 6. Driving: Use a back support (lumbar roll) at the curve of your back. 7. 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.

advices; exercises plus advices

exercises plus advices OTHER

In addition to the same advice of group A, a suggested functional exercise will be performed for this group. 1. Sidestepping against band resistance: 2. The quadriped opposite arm leg aganist resistance . 3. Squat row on a balance board with band resistance: 4. Front raise single leg support with band resistance: 5. The Advanced Prone Bridge: 6. Side sliding on a fitter board (lateral lunge with band):

Also known as: a suggested functional exercise program plus advises.

exercises plus advices

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Doha Ali Amin Ahmed: lead
• Cairo University: collaborator

Study Sites (1)

Cairo university

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Counseling; Exercise

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Doha Ali, master

CONTACT

01019734952; prinessoflight@gmail.com

Mohamed Ahmed, Lecturer

CONTACT

01223631604

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 16, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: November 1, 2024
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)