Mat Pilates Versus General Exercises for Patients With Nonspecific Acute Low Back Pain

Mat Pilates vs. General Exercises for Acute Nonspecific Low Back Pain: A Randomized Controlled Trial

Aim: To compare the effectiveness of Mat Pilates with General Exercises in treating patients with nonspecific acute low back pain.

Novelty: Pilates, typically performed with specific equipment, has shown clinically significant treatment effects in people with chronic low back pain. Recent guidelines recommend patients remain active during episodes of low back pain; however, evidence regarding the type of exercise to perform is limited. Mat Pilates is a type of Pilates exercise that does not require complex equipment. Evaluating the effectiveness of two simple exercise methods (Mat Pilates and General Exercises) can help expand intervention options for patients with acute low back pain, enabling them to choose an exercise they enjoy most.

Study Overview

• Status: Recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Mat Pilates; Other: General Exercises

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed M ElMeligie, Ph.d; Phone Number: +201064442032; Email: mohamed.elmeligie@acu.edu.eg

Study Locations

• Egypt
  • Giza
    • Al Ḩayy Ath Thāmin, Giza, Egypt, 3221405
      • Recruiting
      • Outpatient clinic of faculty of physical therapy, Ahram Canadian University
      • Contact: Mohamed M ElMeligie, Ph.d; Phone Number: 01064442032; Email: mohamed.elmeligie@acu.edu.eg

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Aged between 18 and 50 years old
• Acute nonspecific low back pain with at least 3 points on the Visual Analog Scale (VAS)
• Willing and able to provide informed consent
• Able to comply with the study protocol and attend all treatment sessions and follow-up assessments

Exclusion Criteria:

• Presence of specific low back pain causes, such as lumbar radiculopathy, spinal stenosis, or spondylolisthesis
• Previous spinal surgery
• Contraindications to exercise, such as severe cardiovascular or respiratory conditions
• Currently pregnant or planning to become pregnant during the study period
• Participation in another clinical trial or receiving concurrent experimental treatment for low back pain

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mat Pilates; Mat Pilates exercises targeting core strength, flexibility, and muscle control	Other: Mat Pilates; Duration: 50 minutes per session Repetitions: 8-12 repetitions per exercise Sets: 2-3 sets per exercise Rests: 30-60 seconds rest between sets Frequency: 3 times per week for 4 weeks Exercises: A series of Mat Pilates exercises targeting core strength, flexibility, and muscle control
Active Comparator: General Exercises	Other: General Exercises; General exercise is a structured exercise program designed to help individuals with back pain improve their fitness levels. The program comprises of a series of exercise classes that are led by a physiotherapist. The classes involve a combination of aerobic, strength, and flexibility exercises, and aim to improve overall physical fitness, reduce pain, and improve function. The program is specifically designed for individuals with back pain, and the exercises are tailored to meet the needs of each participant. The Back to Fitness Program is based on the principles of exercise prescription and is intended to be a safe and effective way to manage back pain through exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity	Pain intensity will be assessed using the Visual Analog Scale (VAS) at baseline (pre-treatment), 4 weeks after randomization (post-treatment), 3 months after discharge (follow-up 1). The VAS is a continuous scale comprising a horizontal line, anchored by two verbal descriptors, one for each symptom extreme.	Change from baseline to 4 weeks and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Disability	Disability will be assessed using the Roland-Morris Disability Questionnaire (RMDQ) at baseline (pre-treatment), 10 weeks after randomization (post-treatment), 3 months after discharge (follow-up 1), and 6 months after discharge (follow-up 2). The RMDQ is a 24-item self-report questionnaire measuring level of disability/function in people with low back pain. Higher scores indicate higher disability.	Change from baseline to 4 weeks and 3 months
Change in Pain Pressure Threshold	Pain pressure threshold will be assessed using a pressure algometer at baseline (pre-treatment), 10 weeks after randomization (post-treatment), 3 months after discharge (follow-up 1), and 6 months after discharge (follow-up 2). A pressure algometer objectively evaluates pain sensitivity levels by measuring the minimum stimulus intensity perceived as painful.	Change from baseline to 4 weeks and 3 months

Collaborators and Investigators

• Sponsor: Ahram Canadian University
• Investigators: Study Director: Amal Fawzy, Ph.d, Faculty of Physical Therapy, Ahram Canadian University

Study record dates

Study Major Dates

• Study Start (Estimated): June 30, 2023
• Primary Completion (Estimated): June 10, 2024
• Study Completion (Estimated): June 10, 2024

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 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: 012/00Z001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The researchers of this study are committed to promoting open science and collaboration among researchers. As part of this commitment, we will share de-identified individual participant data (IPD) with other qualified researchers, upon request and in accordance with applicable regulations and ethical guidelines.
• IPD Sharing Time Frame: De-identified IPD will be available for sharing with other researchers starting six months after the publication of the primary study results and will remain accessible for a period of 2 years.
• IPD Sharing Access Criteria: via mohamed.elmeligie@acu.edu.eg
• IPD Sharing Supporting Information Type: SAP; ICF

Drug and device information, study documents

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