- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05232435
Pilate Mat Exercise Versus Muscle Energy Technique on Chronic Non Specific Low Back Pain (MET-LBP)
March 21, 2022 updated by: Hager Nazieh Mohamed Hekal, Cairo University
to investigate the effect of pilat mat exercise versus MET on chronic non specific LBP:Randomized controlled trial
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
87
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: hager na hekal, PHD student
- Phone Number: 00201016549132
- Email: hager_in@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: pilate group
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.
|
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)
|
Experimental: MET
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.
|
Will receive MET for hamstring and erectorspinae plus standard treatment
|
Active Comparator: control group
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.
|
electrical heat pad - stretch hamstring - stretch lower back muscles - stregth abdominal muscles
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 4 weeks for each group
|
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
|
up to 4 weeks for each group
|
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.
|
up to 4 weeks for each group
|
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
|
upto 4 weeks for each group
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: hager hekal, PHD student, Faculty of physical therapy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 30, 2022
Primary Completion (Anticipated)
May 30, 2022
Study Completion (Anticipated)
May 30, 2022
Study Registration Dates
First Submitted
January 12, 2022
First Submitted That Met QC Criteria
January 31, 2022
First Posted (Actual)
February 9, 2022
Study Record Updates
Last Update Posted (Actual)
April 1, 2022
Last Update Submitted That Met QC Criteria
March 21, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/002135
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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