- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05347589
PIR of Quadratus Lumborum With and Without Gluteus Maximus Activation in Innominate Upslip Suprapubic Dysfunction
Effects of Post Isometric Relaxation of Quadratus Lumborum With and Without Gluteus Maximus Activation on Pain, Disability and Pelvic Tilt Angle in Patients With Innominate Upslip Suprapubic Dysfunction
The innominate up slip dysfunction is the most common in athletes and non-athletes, who present with low back pain and sacroiliac dysfunction. The main muscular structure that forms the force closure of the joint involves the bicep femoris and gluteus maximus that are involved in the stability of the of the pelvis through immense attachments through the Sacro-tuberous ligament. The objective of this study is to determine the effectiveness of Post Isometric Relaxation (PIR) of Quadratus lumborum with and without Gluteus maximus activation on pain, disability and pelvic tilt angle in patients with innominate upslip suprapubic dysfunction.
The study will be a randomized controlled trial involving 34 patients both males and females aged 20 to 40 years with history of unilateral pelvic pain not radiating to L5 or above, Positive finding of sitting flexion test, standing flexion tests, stork test and Positive active straight leg raise test will be randomly recruited by consecutive sampling technique. The subjects having ankylosing spondylitis, lumbar radiculopathy, spinal pathologies, or any lumbar fracture will be excluded. All the patients in the study will be randomly assigned into two groups where Group A will be given muscle energy technique of quadratus lumborum along with gluteus maximus activation and Group B will be a control group treated with muscle energy technique only. Both groups will be given buttock squeezing and drawing in maneuver as common treatment along with muscle energy technique. Each session will be repeated for 20 minutes thrice a week. The treatment duration will be 4 weeks. Outcomes will be measured at the first day and then at the end of the 4th week by numeric pain rating scale, modified Oswestry disability index and iHandy inclinometer application. .
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54000
- Recruiting
- Ghurki Trust Teaching Hospital
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Principal Investigator:
- Hafiz Muhammad Uzair, MSPT-OM
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged 20 to 40 years
- Both males & females
- History of unilateral pelvic pain not radiating to L5 or above
- Positive finding of sitting flexion test, standing flexion tests, stork test.
- Positive active straight leg raise test
Exclusion Criteria:
- Subjects diagnosed with ankylosing spondylitis.
- Lumbar radiculopathy
- Spinal pathologies including spondylosis and spondylolisthesis.
- Subjects immediately post pregnancy.
- Disc herniation
- Lumbar fractures or spinal surgeries
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Post isometric relaxation of quadratus lumborum and gluteus Gluteus maximus activation exercises
|
Post Isometric Relaxation: The patient will be in a left recumbent position with his leg in a fully flexed position close to his chest and fixed by his left hand.
The patient is asked to hold the treatment table with a right hand in an overhead position to support the body in applying the technique.
The patient fully extended left will be taken away from the treatment table.
At this point, the patient will be asked to press the leg down until the range where the patient feels discomfort to the point of torsion of Quadratus lumborum.
This is the point that is the barrier range.
Smaller than this range the patient will be asked to lift his left against the counterforce by the therapist and hold it for five to seven seconds which will be followed by five to seven seconds of relaxation.
The technique will be repeated by five times in the pain-free range.
Post Isometric Relaxation: The patient will be in a left recumbent position with his leg in a fully flexed position close to his chest and fixed by his left hand.
The patient is asked to hold the treatment table with a right hand in an overhead position to support the body in applying the technique.
The patient fully extended left will be taken away from the treatment table.
At this point, the patient will be asked to press the leg down until the range where the patient feels discomfort to the point of torsion of Quadratus lumborum.
This is the point that is the barrier range.
Smaller than this range the patient will be asked to lift his left against the counterforce by the therapist and hold it for five to seven seconds which will be followed by five to seven seconds of relaxation.
The technique will be repeated by five times in the pain-free range
|
|
Active Comparator: post isometric relaxation of the Quadratus lumborum
|
Post Isometric Relaxation: The patient will be in a left recumbent position with his leg in a fully flexed position close to his chest and fixed by his left hand.
The patient is asked to hold the treatment table with a right hand in an overhead position to support the body in applying the technique.
The patient fully extended left will be taken away from the treatment table.
At this point, the patient will be asked to press the leg down until the range where the patient feels discomfort to the point of torsion of Quadratus lumborum.
This is the point that is the barrier range.
Smaller than this range the patient will be asked to lift his left against the counterforce by the therapist and hold it for five to seven seconds which will be followed by five to seven seconds of relaxation.
The technique will be repeated by five times in the pain-free range
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Numeric Pain Rating Scale (NPRS)
Time Frame: 4 weeks
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The numeric pain rating scale is a measurement of pain intensity in adults.
The NPRS is a segmented numeric version of visual analogue scale (VAS) in which respondent select a whole number (0 to 10) that best reflects the intensity of pain.
Scores range from 0 to 10
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4 weeks
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Modified Oswestry disability index (MODI)
Time Frame: 4 weeks
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The disability will be measured by using the modified Oswestry Disability Index in individuals with innominate up slip suprapubic dysfunction.
This is an extremely important tool used to measure a patient's permanent functional disability.
The total score ranges from 0 to 50, with each section having a total possible score of 5.
The patient can be further subcategorized into five groups according to their total score: 0%-20% (minimal disability), 20%-41% (moderate disability), 41%-60% (severe disability), 61%-80% (crippled), and 81%-100% (bedridden).
The modified Oswestry Disability Index has a minimum charge of 15.5%.
This measure has been proven to have good validity for detecting changes in the SIJ, with a minimum difference of 13-15 indicating clinical significance
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4 weeks
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I-Handy level inclinometer mobile app
Time Frame: 4 weeks
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The iPhone 12 (Apple Inc, Cupertino, CA, USA) will be used as a measuring instrument with level application (iHandy level).
The iHandy level application is integrated into the iPhone and is a free application with a visual display similar to that of a digital inclinometer in regard to numeric size.
The application uses the iPhones built-in accelerometer and a digital display to display the angle measured..
The unit of measurement will be degrees
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4 weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Patel VD, Eapen C, Ceepee Z, Kamath R. Effect of muscle energy technique with and without strain-counterstrain technique in acute low back pain - A randomized clinical trial. Hong Kong Physiother J. 2018 Jun;38(1):41-51. doi: 10.1142/S1013702518500051. Epub 2018 Apr 4.
- Copay AG, Cher DJ. Is the Oswestry Disability Index a valid measure of response to sacroiliac joint treatment? Qual Life Res. 2016 Feb;25(2):283-292. doi: 10.1007/s11136-015-1095-3. Epub 2015 Aug 6.
- Sarkar M, Goyal M, Samuel AJ. Comparing the Effectiveness of the Muscle Energy Technique and Kinesiotaping in Mechanical Sacroiliac Joint Dysfunction: A Non-blinded, Two-Group, Pretest-Posttest Randomized Clinical Trial Protocol. Asian Spine J. 2021 Feb;15(1):54-63. doi: 10.31616/asj.2019.0300. Epub 2020 Jan 30.
- Sanika V, Prem V, Karvannan H. Comparison of Glutues Maximus Activation to Flexion Bias Exercises Along with MET Technique in Subjects with Anterior Rotated Sacroiliac Joint Dysfunction-a Randomised Controlled Trial. Int J Ther Massage Bodywork. 2021 Mar 1;14(1):30-38. eCollection 2021 Mar.
- Garcia-Penalver UJ, Palop-Montoro MV, Manzano-Sanchez D. Effectiveness of the Muscle Energy Technique versus Osteopathic Manipulation in the Treatment of Sacroiliac Joint Dysfunction in Athletes. Int J Environ Res Public Health. 2020 Jun 22;17(12):4490. doi: 10.3390/ijerph17124490.
- Kamali F, Zamanlou M, Ghanbari A, Alipour A, Bervis S. Comparison of manipulation and stabilization exercises in patients with sacroiliac joint dysfunction patients: A randomized clinical trial. J Bodyw Mov Ther. 2019 Jan;23(1):177-182. doi: 10.1016/j.jbmt.2018.01.014. Epub 2018 Jan 31.
- Ghasemi C, Amiri A, Sarrafzadeh J, Dadgoo M, Jafari H. Comparative study of muscle energy technique, craniosacral therapy, and sensorimotor training effects on postural control in patients with nonspecific chronic low back pain. J Family Med Prim Care. 2020 Feb 28;9(2):978-984. doi: 10.4103/jfmpc.jfmpc_849_19. eCollection 2020 Feb.
- Cana-Pino A, Espejo-Antunez L, Adsuar JC, Apolo-Arenas MD. Test-Retest Reliability of an iPhone(R) Inclinometer Application to Assess the Lumbar Joint Repositioning Error in Non-Specific Chronic Low Back Pain. Int J Environ Res Public Health. 2021 Mar 3;18(5):2489. doi: 10.3390/ijerph18052489.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- REC/Lhr/22/0129 Uzair
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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