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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917743
• Other study ID #: 012/00Z001
• Status: Recruiting
• Phase: N/A
• Start date: June 30, 2023
• Est. completion date: June 10, 2024

Study information

• Verified date: June 2023
• Source: Ahram Canadian University
• Contact: Mohamed M ElMeligie, Ph.d
• Phone: +201064442032
• Email: mohamed.elmeligie[@]acu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 10, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

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
• 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.

Locations

Country	Name	City	State
Egypt	Outpatient clinic of faculty of physical therapy, Ahram Canadian University	Al ?ayy Ath Thamin	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Ahram Canadian University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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