Lumbopelvic Stabilization Versus Pilates Exercises On Gait Phases And Peak Pressure On Foot In Low Back Pain (LBP)

Lumbopelvic Stabilization Versus Pilates Exercises On Gait Cycle Phases And Maximum Peak Pressure On Foot In Chronic Nonspecific Low Back Pain: Randomized Controlled Trial

the purpose of this trial is to investigate and compare between lumbopelvic stabilization and pilates exercises on gait cycle phases and maximum peak pressure on the foot in chronic nonspecific low back pain?

Study Overview

• Status: Not yet recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: lumbopelvic stabilization exercises; Other: conventional therapy; Other: pilates exercise

Detailed Description

LBP is the leading cause of activity limitation, results in significant losses in productivity at work, and incurs billions of dollars in medical expenditure annually So, the aim of physical therapy treatment in the patient with chronic nonspecific low back pain is more effective in improving gait cycle phases and maximum peak pressure on the foot and help LBP patients to walk normally as much as possible, also this will improve our body of knowledge about the best modalities for treating LBP. The finding of this study may help LBP patients avoid exposure to complications due to altered gait cycle phases and maximum peak pressure on the foot. Also, it will help physiotherapists to know which treatment will be effective in improving gait cycle phases and maximum peak pressure on the foot. one hundred patients with mechanical low back pain will be allocated randomly to three groups; group A will receive pilates, group B will receive lumbopelvic stabilization exercise and group C will receive strengthening exercises for the abdominals, back, and hip muscles

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Their age between 20 and 40 years
2. patients is required to have chronic nonspecific LBP (more than12 weeks), defined as Pain in the lumbar and/or buttock region (defined as pain reported below the level of T12 and no lower than the buttock line).
3. Patients will be excluded if they have signs of serious spinal pathology (red flags) including significant trauma, unexplained weight loss, and widespread neurologic changes

Exclusion Criteria:

1. subjects with specific back pain (fracture, osteoporosis or degenerative changes, prolapse intervertebral disc, bone disorders, arthritis, tumour),
2. subjects with neurological involvement (radiculopathy, myelopathy),
3. subjects with previous spinal surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: lumbopelvic stabilization exercises; the patients will receive trunk stabilization exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months	Other: lumbopelvic stabilization exercises; the patients will receive lumbopelvic stabilization in the form of three parts: 1 Segmental control over primary stabilizers (mainly TrA, deep multifidus, pelvic floor and diaphragm) 2-Exercises in closed chain, with low velocity and low load 3-Exercises in open chain, with high velocity and load; Other: conventional therapy; Patients will received strengthening exercises for the abdominal, back, and hip muscles. The patients performed an average of three series of ten repetitions of each exercise. Increases in the number of exercises performed in each session (or load progression) occurred according to individual tolerance
Experimental: Pilates exercises; the patients will receive trunk pilates exercise +strengthening exercises for the abdominal, back, and hip muscles three times/ week for three months	Other: conventional therapy; Patients will received strengthening exercises for the abdominal, back, and hip muscles. The patients performed an average of three series of ten repetitions of each exercise. Increases in the number of exercises performed in each session (or load progression) occurred according to individual tolerance; Other: pilates exercise; the patient will receive pilates exercise in the form of Breast stroke prep, Side leg lift series, One leg circle, Hundreds, Shoulder bridge, and Spine stretch forward
Active Comparator: conventional therapy; the patients will receive trunk stabilization exercise three times/ week for three months	Other: conventional therapy; Patients will received strengthening exercises for the abdominal, back, and hip muscles. The patients performed an average of three series of ten repetitions of each exercise. Increases in the number of exercises performed in each session (or load progression) occurred according to individual tolerance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
gait cycle phases and maximum peak pressure on foot	gait cycle phases and peak pressure will be measure by Tekscan walkway	up to twelve weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	visual analogue scale will be used for measuring pain level	up to twelve weeks
disability	Functional disability of each patient was assessed by Modified Oswestry Disability Questionnaire	up to twelve weeks
muscle endurance	Sorensen test (low back fatigue test) and Trunk flexion endurance test will be used for measuring the level of endurance	up to twelve weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2021
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: June 24, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): June 28, 2021

Study Record Updates

• Last Update Posted (Actual): June 28, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: lumbopelvaic stabilization exercise; pilates exercise; gait cycle phases; peak pressure
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: p.t.REC/012/003225

Drug and device information, study documents

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