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

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mat Pilates
General Exercises
Sponsored by
Ahram Canadian University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Outpatient clinic of faculty of physical therapy, Ahram Canadian UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mat Pilates

General Exercises

Arm Description

Mat Pilates exercises targeting core strength, flexibility, and muscle control

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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.

Full Information

First Posted
June 15, 2023
Last Updated
June 15, 2023
Sponsor
Ahram Canadian University
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1. Study Identification

Unique Protocol Identification Number
NCT05917743
Brief Title
Mat Pilates Versus General Exercises for Patients With Nonspecific Acute Low Back Pain
Official Title
Mat Pilates vs. General Exercises for Acute Nonspecific Low Back Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2023 (Anticipated)
Primary Completion Date
June 10, 2024 (Anticipated)
Study Completion Date
June 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ahram Canadian University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mat Pilates
Arm Type
Experimental
Arm Description
Mat Pilates exercises targeting core strength, flexibility, and muscle control
Arm Title
General Exercises
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Mat Pilates
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
General Exercises
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Pain Intensity
Description
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.
Time Frame
Change from baseline to 4 weeks and 3 months
Secondary Outcome Measure Information:
Title
Change in Disability
Description
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.
Time Frame
Change from baseline to 4 weeks and 3 months
Title
Change in Pain Pressure Threshold
Description
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.
Time Frame
Change from baseline to 4 weeks and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed M ElMeligie, Ph.d
Phone
+201064442032
Email
mohamed.elmeligie@acu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amal Fawzy, Ph.d
Organizational Affiliation
Faculty of Physical Therapy, Ahram Canadian University
Official's Role
Study Director
Facility Information:
Facility Name
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
City
Al Ḩayy Ath Thāmin
State/Province
Giza
ZIP/Postal Code
3221405
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed M ElMeligie, Ph.d
Phone
01064442032
Email
mohamed.elmeligie@acu.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

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

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