Chronic Non Specific Low Back PainMET-LBPNCT05232435
Pilate Mat Exercise Versus Muscle Energy Technique on Chronic Non Specific Low Back Pain
A study testing pilate mat exercise will be performed and MET in people with Chronic Non Specific Low Back Pain, run by Cairo University.
Trial summary
to investigate the effect of pilat mat exercise versus MET on chronic non specific LBP:Randomized controlled trial Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Non Specific Low Back Pain
- What is being tested?
- pilate mat exercise will be performed and MET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2022to 30 May 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Seventyeight Subjects will be selected from both genders, with age above 18 years.
- Normal body mass index (BMI) will be included.
- Participants diagnosed with chronic nonspecific LBP.
Who cannot join
- The participants will be excluded if they had one of the following criteria:
- Patient with previous back surgery, lumbar disc herniation, spinal deformities.
- Neuromusculoskeletal problems as hip arthrodesis or arthroplasty and spondylolisthesis.
- History of Cardiovascular disease, diabetes mellitus and rheumatoid arthritis
- Pregnant women and Osteoprosis.
- Leg length discrepancy.
Trial locations and contacts
No sites are listed yet.
About this study
to investigate the effect of pilat mat exercise versus MET on chronic non specific LBP:Randomized controlled trial
Read the detailed description
Low back pain (LBP) affects almost everyone at least once per life. Hence,it has been considered one of the most common musculoskeletal problems.The Pilates Method starts by strengthening the core, which is achieved by coordinating breathing with movement. Muscle energy technique is an associate degree of osteopathic manipulation methodology. The muscles of patients were used, on request, to type a singular controlled position, in a very specific direction, and against a distinctly executed therapist-applied counterforce.pilate mat exercise and muscle energy technique play a major role in treatment of patients with chronic non specific LBP so this trial will be conducted to investigate the effect of pilat mat exercise versus MET on chronic non specific LBP:
- Conditions
- Chronic Non Specific Low Back Pain
- Being tested
- pilate mat exercise will be performed, MET, control group receive standard treatment
- Keywords
- LBP, Pilate mat exercise, MET
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pilate mat exercise will be performedOther
pilate group:1- bridging 2- shoulder bridge 3- front support 4- spine stretch forward 5- spine twist plus standard treatment(stretch hamstring -stretch lower back - strength abdominal muscles - electrical heat pad)
METOther
Will receive MET for hamstring and erectorspinae plus standard treatment
control group receive standard treatmentOther
electrical heat pad - stretch hamstring - stretch lower back muscles - stregth abdominal muscles
| Study group | Role | What they receive |
|---|---|---|
| pilate group | Experimental | will receive pilate exercise(1- bridging 2- shoulder bridge 3- front support 4- spine stretch forward 5- spine twist) and standard treatment (stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) for 12 sessions(3 sessions/week) over a period of four weeks. Receives: Other: pilate mat exercise will be performed |
| MET | Experimental | will receiveMET treatment for hamstring and erector spinae and standard treatment(stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) for 12 sessions (3 sessions/week)over a period of four weeks. Receives: Other: MET |
| control group | Active comparator | will receive standard treatment(stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) only for 12 sessions (3 sessions/week) over a period of four weeks. Receives: Other: control group receive standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
using visual analogue scale.each patient willbe instructed to rate the current level of pain by placing (X) sign across the horizontal VAS line. The distance in millimeters from the lower limit was measured using a ruler. VAS will be assessed before and after the treatment program.as 1:2 mild , 3:6moderate and 7:10 sever pain.
Measured: up to 4 weeks for each group
functional disability
using ronald morris questioneer.The RMDQ is scored by adding up the number of items the patient has ticked. Scores can vary between 0-24. Greater levels of disability are reflected by higher scores
Measured: up to 4 weeks for each group
ROM
using BROMII.Use the two universal inclinometers to make flexion/extension measurements. Measurements with the universal inclinometer need to be with the patient in an upright position.
- Palpate and mark S1 and T12. Mark on bare skin when possible. This avoids the marks moving with the patient's clothing (Fig.2)
- Center the two inclinometers over the palpation marks and zero with your finger by spinning the dial (zero would then be at the bottom of the inclinometer).
- Have the patient flex forward as far as possible (Fig. 3). Note the reading on each inclinometer.
- The reading on the upper inclinometer is total lumbar flexion. The reading on the lower inclinometer is sacral flexion. The difference between the reading at S1 and T12 is true lumbar flexion.
- Repeat flexion protocol for extension having the patient extend back for full extension instead of flexing forward
Measured: up to 4 weeks for each group
flexibility
using V sit and reach test.The test is done twice with a short break in between . Scoring: Zero point is at the level of feet. (We note negative values towards our body and positive values outward from our body.) The best trial is recorded in centimeters by best score
Measured: upto 4 weeks for each group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start30 Mar 2022 (estimated)
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non Specific Low Back PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- The trial has 3 groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 87 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hager Nazieh Mohamed Hekal, Cairo University
- Investigators
- hager hekal, PHD student, Study chair, faculty of physical therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232435
- Sponsor's protocol ID
- P.T.REC/012/002135
- Acronym
- MET-LBP
- Status last verified
- Mar 2022
- First submitted
- 12 Jan 2022
- Last updated
- 1 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilate Mat Exercise Versus Muscle Energy Technique on Chronic Non Specific Low Back Pain
- ClinicalTrials.gov ID
- NCT05232435
- Acronym / sponsor ID
- MET-LBP / P.T.REC/012/002135
- Conditions
- Chronic Non Specific Low Back Pain
- Keywords
- LBP, Pilate mat exercise, MET
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 87 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 Mar 2022 (estimated)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 9 Feb 2022 (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.
to investigate the effect of pilat mat exercise versus MET on chronic non specific LBP:Randomized controlled trial
Detailed description
Low back pain (LBP) affects almost everyone at least once per life. Hence,it has been considered one of the most common musculoskeletal problems.The Pilates Method starts by strengthening the core, which is achieved by coordinating breathing with movement. Muscle energy technique is an associate degree of osteopathic manipulation methodology. The muscles of patients were used, on request, to type a singular controlled position, in a very specific direction, and against a distinctly executed therapist-applied counterforce.pilate mat exercise and muscle energy technique play a major role in treatment of patients with chronic non specific LBP so this trial will be conducted to investigate the effect of pilat mat exercise versus MET on chronic non specific LBP:
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The trial has 3 groups
| Arm | Type | Receives |
|---|---|---|
| pilate group | Experimental | Other: pilate mat exercise will be performedwill receive pilate exercise(1- bridging 2- shoulder bridge 3- front support 4- spine stretch forward 5- spine twist) and standard treatment (stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) for 12 sessions(3 sessions/week) over a period of four weeks. |
| MET | Experimental | Other: METwill receiveMET treatment for hamstring and erector spinae and standard treatment(stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) for 12 sessions (3 sessions/week)over a period of four weeks. |
| control group | Active comparator | Other: control group receive standard treatmentwill receive standard treatment(stretch hamstring , stretch lower back , strength abdominal muscles and electrical heat pad) only for 12 sessions (3 sessions/week) over a period of four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Seventyeight Subjects will be selected from both genders, with age above 18 years.
- Normal body mass index (BMI) will be included.
- Participants diagnosed with chronic nonspecific LBP.
Key exclusion criteria (6 listed)
- The participants will be excluded if they had one of the following criteria:
- Patient with previous back surgery, lumbar disc herniation, spinal deformities.
- Neuromusculoskeletal problems as hip arthrodesis or arthroplasty and spondylolisthesis.
- History of Cardiovascular disease, diabetes mellitus and rheumatoid arthritis
- Pregnant women and Osteoprosis.
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 |
|---|---|---|
| pilate mat exercise will be performedpilate group:1- bridging 2- shoulder bridge 3- front support 4- spine stretch forward 5- spine twist plus standard treatment(stretch hamstring -stretch lower back - strength abdominal muscles - electrical heat pad) | Other | pilate group |
| METWill receive MET for hamstring and erectorspinae plus standard treatment | Other | MET |
| control group receive standard treatmentelectrical heat pad - stretch hamstring - stretch lower back muscles - stregth abdominal muscles | Other | control group |
Primary outcome
pain intensity
Time frame: up to 4 weeks for each group
using visual analogue scale.each patient willbe instructed to rate the current level of pain by placing (X) sign across the horizontal VAS line. The distance in millimeters from the lower limit was measured using a ruler. VAS will be assessed before and after the treatment program.as 1:2 mild , 3:6moderate and 7:10 sever pain.
functional disability
Time frame: up to 4 weeks for each group
using ronald morris questioneer.The RMDQ is scored by adding up the number of items the patient has ticked. Scores can vary between 0-24. Greater levels of disability are reflected by higher scores
ROM
Time frame: up to 4 weeks for each group
using BROMII.Use the two universal inclinometers to make flexion/extension measurements. Measurements with the universal inclinometer need to be with the patient in an upright position. 1. Palpate and mark S1 and T12. Mark on bare skin when possible. This avoids the marks moving with the patient's clothing (Fig.2) 2. Center the two inclinometers over the palpation marks and zero with your finger by spinning the dial (zero would then be at the bottom of the inclinometer). 3. Have the patient flex forward as far as possible (Fig. 3). Note the reading on each inclinometer. 4. The reading on the upper inclinometer is total lumbar flexion. The reading on the lower inclinometer is sacral flexion. The difference between the reading at S1 and T12 is true lumbar flexion. 5. Repeat flexion protocol for extension having the patient extend back for full extension instead of flexing forward
flexibility
Time frame: upto 4 weeks for each group
using V sit and reach test.The test is done twice with a short break in between . Scoring: Zero point is at the level of feet. (We note negative values towards our body and positive values outward from our body.) The best trial is recorded in centimeters by best score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2022.
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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.
hager hekal, PHD student study chair
faculty of physical therapy
Questions about this trial
What is this clinical trial studying?
A study testing pilate mat exercise will be performed and MET in people with Chronic Non Specific Low Back Pain, run by Cairo University.
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 3 inclusion and 6 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 1 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 hager na hekal, PHD student (00201016549132, hager_in@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: up to 4 weeks for each group). The study lists 4 primary outcomes in all. 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 1 Apr 2022.