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

NCT05917743 | Unknown

• 1 other identifier: 012/00Z001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Disability

  Change from baseline to 4 weeks and 3 months

• Change in Pain Pressure Threshold

  Change from baseline to 4 weeks and 3 months

Study Arms (2)

Mat Pilates

EXPERIMENTAL

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

Other: Mat Pilates

General Exercises

ACTIVE COMPARATOR

Other: General Exercises

Interventions

Mat Pilates OTHER

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

Mat Pilates

General Exercises OTHER

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.

General Exercises

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ahram Canadian University: lead

Study Sites (1)

Outpatient clinic of faculty of physical therapy, Ahram Canadian University

Al Ḩayy Ath Thāmin, Giza Governorate, 3221405, Egypt

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amal Fawzy, Ph.d

  Faculty of Physical Therapy, Ahram Canadian University

  STUDY DIRECTOR

Central Study Contacts

Mohamed M ElMeligie, Ph.d

CONTACT

+201064442032; mohamed.elmeligie@acu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Physical Therapy and Director of Electromyography Lab

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 26, 2023
• Study Start: June 30, 2023
• Primary Completion: June 10, 2024
• Study Completion: June 10, 2024
• Last Updated: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• 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.
• Access Criteria: via mohamed.elmeligie@acu.edu.eg

Locations

EG (1)