NCT04600024

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 20, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 18, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 18, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
Last Updated

October 23, 2020

Status Verified

September 1, 2020

Enrollment Period

1.9 years

First QC Date

October 18, 2020

Last Update Submit

October 22, 2020

Conditions

Keywords

AnthropometryPelvic BonesMuscle Syndrome, PiriformisProspective StudiesCase-Control Studiesfemur neck / pathology

Outcome Measures

Primary Outcomes (5)

  • 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.

    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

    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

    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

    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

    The measurement was evaluated by two different investigators immediately after the pelvis anteroposterior radiography was taken.

Study Arms (2)

Piriformis syndrome group

Patients who were diagnosed as PS by diagnostic injection with ultrasound guidance

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

Interventions

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.

Piriformis syndrome group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The physical medicine and rehabilitation outpatient clinic of Fatih Sultan Mehmet Training and Research Hospital

You may qualify if:

  • A dramatic relief of pain following piriformis muscle local anesthetic injection

You may not qualify if:

  • 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
  • For the control group
  • Having Anteroposterior pelvic radiographs for other medical reasons
  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Research and Traning Hospital

Istanbul, 34752, Turkey (TĂ¼rkiye)

Location

Related Publications (26)

  • Kirschner JS, Foye PM, Cole JL. Piriformis syndrome, diagnosis and treatment. Muscle Nerve. 2009 Jul;40(1):10-8. doi: 10.1002/mus.21318.

    PMID: 19466717BACKGROUND
  • Jankovic 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.

    PMID: 23893704BACKGROUND
  • Hopayian 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.

    PMID: 20596735BACKGROUND
  • Papadopoulos 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.

    PMID: 15062719BACKGROUND
  • Probst 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.

    PMID: 31102324BACKGROUND
  • Benson ER, Schutzer SF. Posttraumatic piriformis syndrome: diagnosis and results of operative treatment. J Bone Joint Surg Am. 1999 Jul;81(7):941-9.

    PMID: 10428125BACKGROUND
  • Pace JB, Henning C. Episacroiliac lipoma. Am Fam Physician. 1972 Sep;6(3):70-3. No abstract available.

    PMID: 4262540BACKGROUND
  • Coskun 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.

    PMID: 25113012BACKGROUND
  • Durrani 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.

  • Hopayian 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.

  • Kean 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.

  • Hallin RP. Sciatic pain and the piriformis muscle. Postgrad Med. 1983 Aug;74(2):69-72. doi: 10.1080/00325481.1983.11698378. No abstract available.

  • Niu 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.

  • Rodrigue T, Hardy RW. Diagnosis and treatment of piriformis syndrome. Neurosurg Clin N Am. 2001 Apr;12(2):311-9.

  • Misirlioglu 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.

  • Haladaj R, Pingot M, Polguj M, Wysiadecki G, Topol M. Anthropometric Study of the Piriformis Muscle and Sciatic Nerve: A Morphological Analysis in a Polish Population. Med Sci Monit. 2015 Dec 2;21:3760-8. doi: 10.12659/msm.894353.

  • Guvencer M, Akyer P, Iyem C, Tetik S, Naderi S. Anatomic considerations and the relationship between the piriformis muscle and the sciatic nerve. Surg Radiol Anat. 2008 Aug;30(6):467-74. doi: 10.1007/s00276-008-0350-5. Epub 2008 May 6.

  • Menge TJ, Truex NW. Femoroacetabular impingement: a common cause of hip pain. Phys Sportsmed. 2018 May;46(2):139-144. doi: 10.1080/00913847.2018.1436844. Epub 2018 Feb 13.

  • Krueger DR, Windler M, Gesslein M, Schuetz M, Perka C, Schroeder JH. Is the evaluation of the anterior inferior iliac spine (AIIS) in the AP pelvis possible? Analysis of conventional X-rays and 3D-CT reconstructions. Arch Orthop Trauma Surg. 2017 Jul;137(7):975-980. doi: 10.1007/s00402-017-2694-y. Epub 2017 Apr 21.

  • Bredella MA, Azevedo DC, Oliveira AL, Simeone FJ, Chang CY, Stubbs AJ, Torriani M. Pelvic morphology in ischiofemoral impingement. Skeletal Radiol. 2015 Feb;44(2):249-53. doi: 10.1007/s00256-014-2041-0. Epub 2014 Nov 6.

  • Gomez-Hoyos J, Schroder R, Reddy M, Palmer IJ, Martin HD. Femoral Neck Anteversion and Lesser Trochanteric Retroversion in Patients With Ischiofemoral Impingement: A Case-Control Magnetic Resonance Imaging Study. Arthroscopy. 2016 Jan;32(1):13-8. doi: 10.1016/j.arthro.2015.06.034. Epub 2015 Sep 7.

  • Boese CK, Frink M, Jostmeier J, Haneder S, Dargel J, Eysel P, Lechler P. The Modified Femoral Neck-Shaft Angle: Age- and Sex-Dependent Reference Values and Reliability Analysis. Biomed Res Int. 2016;2016:8645027. doi: 10.1155/2016/8645027. Epub 2016 Dec 14.

  • Elbuken F, Baykara M, Ozturk C. Standardisation of the neck-shaft angle and measurement of age-, gender- and BMI-related changes in the femoral neck using DXA. Singapore Med J. 2012 Sep;53(9):587-90.

  • Gilligan I, Chandraphak S, Mahakkanukrauh P. Femoral neck-shaft angle in humans: variation relating to climate, clothing, lifestyle, sex, age and side. J Anat. 2013 Aug;223(2):133-51. doi: 10.1111/joa.12073. Epub 2013 Jun 19.

  • Fischer CS, Kuhn JP, Volzke H, Ittermann T, Gumbel D, Kasch R, Haralambiev L, Laqua R, Hinz P, Lange J. The neck-shaft angle: an update on reference values and associated factors. Acta Orthop. 2020 Feb;91(1):53-57. doi: 10.1080/17453674.2019.1690873. Epub 2019 Nov 18.

  • Fearon A, Stephens S, Cook J, Smith P, Neeman T, Cormick W, Scarvell J. The relationship of femoral neck shaft angle and adiposity to greater trochanteric pain syndrome in women. A case control morphology and anthropometric study. Br J Sports Med. 2012 Sep;46(12):888-92. doi: 10.1136/bjsports-2011-090744. Epub 2012 Apr 30.

MeSH Terms

Conditions

Piriformis Muscle Syndrome

Condition Hierarchy (Ancestors)

Sciatic NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesNeuralgiaPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPelvic Pain

Study Officials

  • Gamze GĂ¼leç, MD

    Fatih Sultan Mehmet Training and Research Hospital

    STUDY DIRECTOR
  • Ilknur Aktas, MD

    Fatih Sultan Mehmet Training and Research Hospital

    STUDY DIRECTOR
  • Feyza Unlu Ozkan, MD

    Fatih Sultan Mehmet Training and Research Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2020

First Posted

October 23, 2020

Study Start

April 20, 2018

Primary Completion

March 18, 2020

Study Completion

June 18, 2020

Last Updated

October 23, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations