Innominate Upslip Suprapubic DysfunctionNCT05347589
PIR of Quadratus Lumborum With and Without Gluteus Maximus Activation in Innominate Upslip Suprapubic Dysfunction
A study testing Post isometric relaxation of quadratus lumborum and gluteus Gluteus maximus activation exercises and post isometric relaxation of the Quadratus lumborum in people with Innominate Upslip Suprapubic Dysfunction, run by Riphah International University at 1 site in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Innominate Upslip Suprapubic Dysfunction
- What is being tested?
- Post isometric relaxation of quadratus lumborum and gluteus Gluteus maximus activation exercises and post isometric relaxation of the Quadratus lumborum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Apr 2022to 10 Jan 2023
- 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 20 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Subjects diagnosed with ankylosing spondylitis.
- Lumbar radiculopathy
- Spinal pathologies including spondylosis and spondylolisthesis.
- Subjects immediately post pregnancy.
- Disc herniation
- Lumbar fractures or spinal surgeries
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Ghurki Trust Teaching Hospital
Lahore, Punjab Province, 54000
Saima Zahid, PhD*, 03334349520, saima.zahid@riphah.edu.pk
Hafiz Muhammad Uzair, MSPT-OM
About this study
Official title: 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. .
- Conditions
- Innominate Upslip Suprapubic Dysfunction
- Being tested
- Post isometric relaxation of quadratus lumborum and gluteus Gluteus maximus activation exercises, post isometric relaxation of the Quadratus lumborum
- Keywords
- sacroiliac joint, suprapubic dysfunction, Muscle pain, Innominate upslip, pelvis
- Medical subject headings
- Myalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post isometric relaxation of quadratus lumborum and gluteus Gluteus maximus activation exercisesOther
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 of the Quadratus lumborumOther
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
| Study group | Role | What they receive |
|---|---|---|
| Post isometric relaxation of quadratus lumborum and gluteus Gluteus maximus activation exercises | Experimental | Not described Receives: Other: Post isometric relaxation of quadratus lumborum and gluteus Gluteus maximus activation exercises; Other: post isometric relaxation of the Quadratus lumborum |
| post isometric relaxation of the Quadratus lumborum | Active comparator | Not described Receives: Other: post isometric relaxation of the Quadratus lumborum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale (NPRS)
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
Measured: 4 weeks
Modified Oswestry disability index (MODI)
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
Measured: 4 weeks
I-Handy level inclinometer mobile app
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
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2022
- Study start25 Apr 2022
- Primary completion25 Dec 2022 (estimated)
- Study completion10 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Innominate Upslip Suprapubic DysfunctionStudies of the same condition, open and under way.
- More trials run by Riphah International 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saima Zahid, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347589
- Sponsor's protocol ID
- REC/Lhr/22/0129 Uzair
- Status last verified
- Jun 2022
- First submitted
- 21 Apr 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32580480Sarkar 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.
PubMed 31992024Patel 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.
PubMed 30930578Kamali 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.
PubMed 30691749Ghasemi 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.
PubMed 32318454Sanika 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.
PubMed 33654504Copay 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.
PubMed 26245709Cana-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.
PubMed 33802528
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05347589
- Acronym / sponsor ID
- REC/Lhr/22/0129 Uzair
- Conditions
- Innominate Upslip Suprapubic Dysfunction
- Keywords
- sacroiliac joint, suprapubic dysfunction, Muscle pain, Innominate upslip, pelvis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 25 Dec 2022 (estimated)
- Study completion
- 10 Jan 2023 (estimated)
- First posted
- 26 Apr 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post isometric relaxation of quadratus lumborum and gluteus Gluteus maximus activation exercises | Experimental | Other: Post isometric relaxation of quadratus lumborum and gluteus Gluteus maximus activation exercises, Other: post isometric relaxation of the Quadratus lumborum |
| post isometric relaxation of the Quadratus lumborum | Active comparator | Other: post isometric relaxation of the Quadratus lumborum |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Subjects diagnosed with ankylosing spondylitis.
- Lumbar radiculopathy
- Spinal pathologies including spondylosis and spondylolisthesis.
- Subjects immediately post pregnancy.
- Disc herniation
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 |
|---|---|---|
| Post isometric relaxation of quadratus lumborum and gluteus Gluteus maximus activation exercisesPost 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. | Other | Post isometric relaxation of quadratus lumborum and gluteus Gluteus maximus activation exercises |
| post isometric relaxation of the Quadratus lumborumPost 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 | Other | Post isometric relaxation of quadratus lumborum and gluteus Gluteus maximus activation exercises, post isometric relaxation of the Quadratus lumborum |
Primary outcome
Numeric Pain Rating Scale (NPRS)
Time frame: 4 weeks
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
Modified Oswestry disability index (MODI)
Time frame: 4 weeks
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
I-Handy level inclinometer mobile app
Time frame: 4 weeks
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Background: PubMed 32580480Garcia-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.
- Background: PubMed 31992024Sarkar 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.
- Background: PubMed 30930578Patel 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.
- Background: PubMed 30691749Kamali 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.
- Background: PubMed 32318454Ghasemi 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.
- Background: PubMed 33654504Sanika 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.
- Background: PubMed 26245709Copay 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.
- Background: PubMed 33802528Cana-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.
- Individual participant dataSharing planned: No
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.
Saima Zahid, PhD* principal investigator
Riphah International 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 Post isometric relaxation of quadratus lumborum and gluteus Gluteus maximus activation exercises and post isometric relaxation of the Quadratus lumborum in people with Innominate Upslip Suprapubic Dysfunction, run by Riphah International University at 1 site in Pakistan.
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 5 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 16 Jun 2022. 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 Pakistan. 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 Saima Zahid, PhD* (03334349520, Saima.zahid@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Pain Rating Scale (NPRS) (time frame: 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05347589, which also lists 8 linked publications.
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 16 Jun 2022.