Low Back PainNCT05917743
Mat Pilates Versus General Exercises for Patients With Nonspecific Acute Low Back Pain
A study testing Mat Pilates and General Exercises in people with Low Back Pain, run by Ahram Canadian University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Mat Pilates and General Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Jun 2023to 10 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Outpatient clinic of faculty of physical therapy, Ahram Canadian University
Al Ḩayy Ath Thāmin, Giza Governorate, 3221405
Mohamed M ElMeligie, Ph.d, 01064442032, mohamed.elmeligie@acu.edu.eg
About this study
Official title: 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.
- Conditions
- Low Back Pain
- Being tested
- Mat Pilates, General Exercises
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mat PilatesOther
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 ExercisesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Mat Pilates | Experimental | Mat Pilates exercises targeting core strength, flexibility, and muscle control Receives: Other: Mat Pilates |
| General Exercises | Active comparator | Not described Receives: Other: General Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 4 weeks and 3 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: Change from baseline to 4 weeks and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2023
- Study start30 Jun 2023 (estimated)
- Primary completion10 Jun 2024 (estimated)
- Study completion10 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ahram Canadian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Magdy ElMeligie, Ahram Canadian University
- Investigators
- Amal Fawzy, Ph.d, Study director, Faculty of Physical Therapy, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917743
- Sponsor's protocol ID
- 012/00Z001
- Status last verified
- Jun 2023
- First submitted
- 15 Jun 2023
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mat Pilates vs. General Exercises for Acute Nonspecific Low Back Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05917743
- Acronym / sponsor ID
- 012/00Z001
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ahram Canadian UniversityUniversity, hospital or other
- Study start
- 30 Jun 2023 (estimated)
- Primary completion
- 10 Jun 2024 (estimated)
- Study completion
- 10 Jun 2024 (estimated)
- First posted
- 26 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mat Pilates | Experimental | Other: Mat PilatesMat Pilates exercises targeting core strength, flexibility, and muscle control |
| General Exercises | Active comparator | Other: General Exercises |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mat PilatesDuration: 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 | Other | Mat Pilates |
| General ExercisesGeneral 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. | Other | General Exercises |
Primary outcome
Change in Pain Intensity
Time frame: 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.
2 secondary outcomes
Change in Disability
Time frame: Change from baseline to 4 weeks and 3 months
Change in Pain Pressure Threshold
Time frame: Change from baseline to 4 weeks and 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2023.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amal Fawzy, Ph.d study director
Faculty of Physical Therapy, Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mat Pilates and General Exercises in people with Low Back Pain, run by Ahram Canadian University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed M ElMeligie, Ph.d (+201064442032, mohamed.elmeligie@acu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity (time frame: Change from baseline to 4 weeks and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2023.