Piriformis Muscle SyndromeNCT04600024
Pelvic and Hip Morphometry in Piriformis Syndrome
An observational study of Piriformis Muscle Syndrome and Anthropometry, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this case-control study, 23 patients diagnosed as PS by diagnostic injection with ultrasound guidance were selected as the study group. 22 patients who were excluded from the diagnosis of PS and had anteroposterior (AP) direct radiographic imaging were evaluated as the control group. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Piriformis Muscle Syndrome, Anthropometry
- What is being tested?
- Ultrasound guided diagnostic injection
- Type of treatment
- Injection or infusion
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2018to 18 Jun 2020
- Phase
- Observational
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The physical medicine and rehabilitation outpatient clinic of Fatih Sultan Mehmet Training and Research Hospital
Who may be able to join
- A dramatic relief of pain following piriformis muscle local anesthetic injection
- -Having Anteroposterior pelvic radiographs for other medical reasons
Who cannot join
- Having a neurological deficiency
- Having lumbar, sacroiliac, hip, and thoracolumbar pathology (inflammatory or degenerative)
- Operation history at the lumbar and hip region
- Being in the gestational or lactational period
- Body mass index of greater than 35
- History of inflammatory or infectious disease
Show all 16Show fewer
- Active psychiatric illness, severe systemic, vascular or malign disease
- For the control group
- Having a present piriformis syndrome or a history of piriformis syndrome
- Having a neurological deficiency
- Having lumbar, sacroiliac, hip, and thoracolumbar pathology (inflammatory or degenerative)
- Operation history at the lumbar and hip region
- Being in the gestational or lactational period
- Body mass index of greater than 35
- History of inflammatory or infectious disease
- Active psychiatric illness, severe systemic, vascular or malign disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Research and Traning Hospital
Istanbul, 34752
About this study
Official title: The Importance of Pelvic Morphometric Measurements in Piriformis Syndrome: A Case-control Study
In this case-control study, 23 patients diagnosed as PS by diagnostic injection with ultrasound guidance were selected as the study group. 22 patients who were excluded from the diagnosis of PS and had anteroposterior (AP) direct radiographic imaging were evaluated as the control group. On the AP Pelvic graph, the femoral neck-shaft angle, the distances between predetermined bony landmarks were measured blindly without knowing the diagnosis, and the findings were compared statistically.
This study aims to evaluate whether the anatomical structure of the pelvis predisposes to the etiopathogenesis of the piriformis syndrome.
Read the detailed description
Piriformis syndrome (PS) is a neuromuscular disorder consisting of pain and symptoms caused by compression of the sciatic nerve and other structures that pass under the piriformis muscle (PM). Due to difficulties in diagnosis, PS is confused with other pathologies such as lumbar disc pathology, lumbosacral radiculopathy, and sacroiliac dysfunction. As a result, patients are exposed to unnecessary and ineffective treatments, even surgery. The main problems in the PS diagnosis are the absence of objective physical examination findings, radiological findings, and a clear etiology. When the pathophysiology and etiology of PS are considered, there is no identifiable cause in most patients. Previous studies suggest that trauma, anatomical variations, and the trigger point in the muscle may cause PS. No study in the literature radiologically examined the pelvis or hip bone morphological features in PS to the best of our knowledge. This study aims to determine whether pelvic or hip bone morphology features pose a risk for PS in this study.
- Conditions
- Piriformis Muscle Syndrome, Anthropometry
- Being tested
- Ultrasound guided diagnostic injection
- Keywords
- Anthropometry, Pelvic Bones, Muscle Syndrome, Piriformis, Prospective Studies, Case-Control Studies, femur neck / pathology
- Medical subject headings
- Piriformis Muscle Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided diagnostic injectionDiagnostic test
4 cc lidocaine %2 injection into the piriformis muscle was performed for the diagnosis of piriformis syndrome. It was performed by the ultrasound-guidance to increase the accuracy of the injection.
| Study group | Role | What they receive |
|---|---|---|
| Piriformis syndrome group | Patients who were diagnosed as PS by diagnostic injection with ultrasound guidance Receives: Diagnostic Test: Ultrasound guided diagnostic injection | |
| Age and sex match control group | Patients who were excluded from the diagnosis of PS and had anteroposterior (AP) direct radiographic imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral Neck-Shaft Angle (NSA)
The NSA, also called caput collum-diaphyseal angle or inclination angle, defined as the angle between the longitudinal femoral shaft axis and femoral head-neck axis.
Measured: The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.
Posterior Superior Iliac Spine (PSIS)- Trochanter Major (TM)
The distance between the posterior superior iliac spine and the greater trochanter
Measured: The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.
PSIS-Ischial Tuberosity (IT)
The distance between the posterior superior iliac spine and the apex of the ischial tuberosity
Measured: The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.
IT-TM
The distance between the apex of the ischial tuberosity and the greater trochanter
Measured: The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.
Sacrum-TM
The distance between the sacrum and the greater trochanter
Measured: The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2020
- Study start20 Apr 2018
- Primary completion18 Mar 2020
- Study completion18 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)Papers the sponsor has linked to this study.
- Other trials for Piriformis Muscle SyndromeStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gamze Güleç, MD, Study director, Fatih Sultan Mehmet Training and Research HospitalIlknur Aktas, MD, Study director, Fatih Sultan Mehmet Training and Research HospitalFeyza Unlu Ozkan, MD, Study chair, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04600024
- Sponsor's protocol ID
- FSMEAH
- Status last verified
- Sep 2020
- First submitted
- 18 Oct 2020
- Last updated
- 23 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kirschner JS, Foye PM, Cole JL. Piriformis syndrome, diagnosis and treatment. Muscle Nerve. 2009 Jul;40(1):10-8. doi: 10.1002/mus.21318.
PubMed 19466717Jankovic D, Peng P, van Zundert A. Brief review: piriformis syndrome: etiology, diagnosis, and management. Can J Anaesth. 2013 Oct;60(10):1003-12. doi: 10.1007/s12630-013-0009-5. Epub 2013 Jul 27.
PubMed 23893704Hopayian K, Song F, Riera R, Sambandan S. The clinical features of the piriformis syndrome: a systematic review. Eur Spine J. 2010 Dec;19(12):2095-109. doi: 10.1007/s00586-010-1504-9. Epub 2010 Jul 3.
PubMed 20596735Papadopoulos EC, Khan SN. Piriformis syndrome and low back pain: a new classification and review of the literature. Orthop Clin North Am. 2004 Jan;35(1):65-71. doi: 10.1016/S0030-5898(03)00105-6.
PubMed 15062719Probst D, Stout A, Hunt D. Piriformis Syndrome: A Narrative Review of the Anatomy, Diagnosis, and Treatment. PM R. 2019 Aug;11 Suppl 1:S54-S63. doi: 10.1002/pmrj.12189. Epub 2019 Jul 22.
PubMed 31102324Benson ER, Schutzer SF. Posttraumatic piriformis syndrome: diagnosis and results of operative treatment. J Bone Joint Surg Am. 1999 Jul;81(7):941-9.
PubMed 10428125Pace JB, Henning C. Episacroiliac lipoma. Am Fam Physician. 1972 Sep;6(3):70-3. No abstract available.
PubMed 4262540Coskun Benlidayi I, Guzel R, Basaran S, Aksungur EH, Seydaoglu G. Is coxa valga a predictor for the severity of knee osteoarthritis? A cross-sectional study. Surg Radiol Anat. 2015 May;37(4):369-76. doi: 10.1007/s00276-014-1359-6. Epub 2014 Aug 12.
PubMed 25113012Durrani Z, Winnie AP. Piriformis muscle syndrome: an underdiagnosed cause of sciatica. J Pain Symptom Manage. 1991 Aug;6(6):374-9. doi: 10.1016/0885-3924(91)90029-4.
PubMed 1880438Hopayian K, Danielyan A. Four symptoms define the piriformis syndrome: an updated systematic review of its clinical features. Eur J Orthop Surg Traumatol. 2018 Feb;28(2):155-164. doi: 10.1007/s00590-017-2031-8. Epub 2017 Aug 23.
PubMed 28836092Kean Chen C, Nizar AJ. Prevalence of piriformis syndrome in chronic low back pain patients. A clinical diagnosis with modified FAIR test. Pain Pract. 2013 Apr;13(4):276-81. doi: 10.1111/j.1533-2500.2012.00585.x. Epub 2012 Aug 2.
PubMed 22863240Hallin RP. Sciatic pain and the piriformis muscle. Postgrad Med. 1983 Aug;74(2):69-72. doi: 10.1080/00325481.1983.11698378. No abstract available.
PubMed 6878094Niu CC, Lai PL, Fu TS, Chen LH, Chen WJ. Ruling out piriformis syndrome before diagnosing lumbar radiculopathy. Chang Gung Med J. 2009 Mar-Apr;32(2):182-7.
PubMed 19403008Rodrigue T, Hardy RW. Diagnosis and treatment of piriformis syndrome. Neurosurg Clin N Am. 2001 Apr;12(2):311-9.
PubMed 11525209Misirlioglu TO, Akgun K, Palamar D, Erden MG, Erbilir T. Piriformis syndrome: comparison of the effectiveness of local anesthetic and corticosteroid injections: a double-blinded, randomized controlled study. Pain Physician. 2015 Mar-Apr;18(2):163-71.
PubMed 25794202
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Importance of Pelvic Morphometric Measurements in Piriformis Syndrome: A Case-control Study
- ClinicalTrials.gov ID
- NCT04600024
- Acronym / sponsor ID
- FSMEAH
- Conditions
- Piriformis Muscle Syndrome, Anthropometry
- Keywords
- Anthropometry, Pelvic Bones, Muscle Syndrome, Piriformis, Prospective Studies, Case-Control Studies, femur neck / pathology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 18 Mar 2020 (actual)
- Study completion
- 18 Jun 2020 (actual)
- First posted
- 23 Oct 2020 (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.
In this case-control study, 23 patients diagnosed as PS by diagnostic injection with ultrasound guidance were selected as the study group. 22 patients who were excluded from the diagnosis of PS and had anteroposterior (AP) direct radiographic imaging were evaluated as the control group. On the AP Pelvic graph, the femoral neck-shaft angle, the distances between predetermined bony landmarks were measured blindly without knowing the diagnosis, and the findings were compared statistically.
This study aims to evaluate whether the anatomical structure of the pelvis predisposes to the etiopathogenesis of the piriformis syndrome.
Detailed description
Piriformis syndrome (PS) is a neuromuscular disorder consisting of pain and symptoms caused by compression of the sciatic nerve and other structures that pass under the piriformis muscle (PM). Due to difficulties in diagnosis, PS is confused with other pathologies such as lumbar disc pathology, lumbosacral radiculopathy, and sacroiliac dysfunction. As a result, patients are exposed to unnecessary and ineffective treatments, even surgery. The main problems in the PS diagnosis are the absence of objective physical examination findings, radiological findings, and a clear etiology. When the pathophysiology and etiology of PS are considered, there is no identifiable cause in most patients. Previous studies suggest that trauma, anatomical variations, and the trigger point in the muscle may cause PS. No study in the literature radiologically examined the pelvis or hip bone morphological features in PS to the best of our knowledge. This study aims to determine whether pelvic or hip bone morphology features pose a risk for PS in this study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piriformis syndrome group | – | Diagnostic Test: Ultrasound guided diagnostic injectionPatients who were diagnosed as PS by diagnostic injection with ultrasound guidance |
| Age and sex match control group | – | –Patients who were excluded from the diagnosis of PS and had anteroposterior (AP) direct radiographic imaging |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The physical medicine and rehabilitation outpatient clinic of Fatih Sultan Mehmet Training and Research Hospital
Key inclusion criteria (2 listed)
- A dramatic relief of pain following piriformis muscle local anesthetic injection
- -Having Anteroposterior pelvic radiographs for other medical reasons
Key exclusion criteria (16 listed)
- Having a neurological deficiency
- Having lumbar, sacroiliac, hip, and thoracolumbar pathology (inflammatory or degenerative)
- Operation history at the lumbar and hip region
- Being in the gestational or lactational period
- Body mass index of greater than 35
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 |
|---|---|---|
| Ultrasound guided diagnostic injection4 cc lidocaine %2 injection into the piriformis muscle was performed for the diagnosis of piriformis syndrome. It was performed by the ultrasound-guidance to increase the accuracy of the injection. | Diagnostic test | Piriformis syndrome group |
Primary outcome
Femoral Neck-Shaft Angle (NSA)
Time frame: The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.
The NSA, also called caput collum-diaphyseal angle or inclination angle, defined as the angle between the longitudinal femoral shaft axis and femoral head-neck axis.
Posterior Superior Iliac Spine (PSIS)- Trochanter Major (TM)
Time frame: The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.
The distance between the posterior superior iliac spine and the greater trochanter
PSIS-Ischial Tuberosity (IT)
Time frame: The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.
The distance between the posterior superior iliac spine and the apex of the ischial tuberosity
IT-TM
Time frame: The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.
The distance between the apex of the ischial tuberosity and the greater trochanter
Sacrum-TM
Time frame: The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.
The distance between the sacrum and the greater trochanter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Background: PubMed 19466717Kirschner JS, Foye PM, Cole JL. Piriformis syndrome, diagnosis and treatment. Muscle Nerve. 2009 Jul;40(1):10-8. doi: 10.1002/mus.21318.
- Background: PubMed 23893704Jankovic D, Peng P, van Zundert A. Brief review: piriformis syndrome: etiology, diagnosis, and management. Can J Anaesth. 2013 Oct;60(10):1003-12. doi: 10.1007/s12630-013-0009-5. Epub 2013 Jul 27.
- Background: PubMed 20596735Hopayian K, Song F, Riera R, Sambandan S. The clinical features of the piriformis syndrome: a systematic review. Eur Spine J. 2010 Dec;19(12):2095-109. doi: 10.1007/s00586-010-1504-9. Epub 2010 Jul 3.
- Background: PubMed 15062719Papadopoulos EC, Khan SN. Piriformis syndrome and low back pain: a new classification and review of the literature. Orthop Clin North Am. 2004 Jan;35(1):65-71. doi: 10.1016/S0030-5898(03)00105-6.
- Background: PubMed 31102324Probst D, Stout A, Hunt D. Piriformis Syndrome: A Narrative Review of the Anatomy, Diagnosis, and Treatment. PM R. 2019 Aug;11 Suppl 1:S54-S63. doi: 10.1002/pmrj.12189. Epub 2019 Jul 22.
- Background: PubMed 10428125Benson ER, Schutzer SF. Posttraumatic piriformis syndrome: diagnosis and results of operative treatment. J Bone Joint Surg Am. 1999 Jul;81(7):941-9.
- Background: PubMed 4262540Pace JB, Henning C. Episacroiliac lipoma. Am Fam Physician. 1972 Sep;6(3):70-3. No abstract available.
- Background: PubMed 25113012Coskun Benlidayi I, Guzel R, Basaran S, Aksungur EH, Seydaoglu G. Is coxa valga a predictor for the severity of knee osteoarthritis? A cross-sectional study. Surg Radiol Anat. 2015 May;37(4):369-76. doi: 10.1007/s00276-014-1359-6. Epub 2014 Aug 12.
- Results publication: PubMed 1880438Durrani Z, Winnie AP. Piriformis muscle syndrome: an underdiagnosed cause of sciatica. J Pain Symptom Manage. 1991 Aug;6(6):374-9. doi: 10.1016/0885-3924(91)90029-4.
- Results publication: PubMed 28836092Hopayian K, Danielyan A. Four symptoms define the piriformis syndrome: an updated systematic review of its clinical features. Eur J Orthop Surg Traumatol. 2018 Feb;28(2):155-164. doi: 10.1007/s00590-017-2031-8. Epub 2017 Aug 23.
- Results publication: PubMed 22863240Kean Chen C, Nizar AJ. Prevalence of piriformis syndrome in chronic low back pain patients. A clinical diagnosis with modified FAIR test. Pain Pract. 2013 Apr;13(4):276-81. doi: 10.1111/j.1533-2500.2012.00585.x. Epub 2012 Aug 2.
- Results publication: PubMed 6878094Hallin RP. Sciatic pain and the piriformis muscle. Postgrad Med. 1983 Aug;74(2):69-72. doi: 10.1080/00325481.1983.11698378. No abstract available.
- Individual participant dataSharing planned: No
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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.
Gamze Güleç, MD study director
Fatih Sultan Mehmet Training and Research Hospital
Ilknur Aktas, MD study director
Fatih Sultan Mehmet Training and Research Hospital
Feyza Unlu Ozkan, MD study chair
Fatih Sultan Mehmet Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Piriformis Muscle Syndrome and Anthropometry, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 16 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: finished, as of the sponsor's last update on 23 Oct 2020. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral Neck-Shaft Angle (NSA) (time frame: The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.). The study lists 5 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 NCT04600024, which also lists 26 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 23 Oct 2020.