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

Sponsor
Ahram Canadian University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05917743
Collaborator
(none)
60
1
2
11.4
5.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mat Pilates
  • Other: General Exercises
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Mat Pilates vs. General Exercises for Acute Nonspecific Low Back Pain: A Randomized Controlled Trial
Anticipated Study Start Date :
Jun 30, 2023
Anticipated Primary Completion Date :
Jun 10, 2024
Anticipated Study Completion Date :
Jun 10, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in Pain Intensity [Change from baseline to 4 weeks and 3 months]

    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

  1. Change in Disability [Change from baseline to 4 weeks and 3 months]

    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.

  2. Change in Pain Pressure Threshold [Change from baseline to 4 weeks and 3 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Outpatient clinic of faculty of physical therapy, Ahram Canadian University Al Ḩayy Ath Thāmin Giza Egypt 3221405

Sponsors and Collaborators

  • Ahram Canadian University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mohamed Magdy ElMeligie, Lecturer of Physical Therapy and Director of Electromyography Lab, Ahram Canadian University
ClinicalTrials.gov Identifier:
NCT05917743
Other Study ID Numbers:
  • 012/00Z001
First Posted:
Jun 26, 2023
Last Update Posted:
Jun 26, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 26, 2023