Pelvic and Hip Morphometry in Piriformis Syndrome

Sponsor
Fatih Sultan Mehmet Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04600024
Collaborator
(none)
45
1
26
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Ultrasound guided diagnostic injection

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

Study Type:
Observational
Actual Enrollment :
45 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Importance of Pelvic Morphometric Measurements in Piriformis Syndrome: A Case-control Study
Actual Study Start Date :
Apr 20, 2018
Actual Primary Completion Date :
Mar 18, 2020
Actual Study Completion Date :
Jun 18, 2020

Arms and Interventions

Arm Intervention/Treatment
Piriformis syndrome group

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

Diagnostic Test: Ultrasound guided diagnostic injection
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.

Age and sex match control group

Patients who were excluded from the diagnosis of PS and had anteroposterior (AP) direct radiographic imaging

Outcome Measures

Primary Outcome Measures

  1. Femoral Neck-Shaft Angle (NSA) [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.

  2. Posterior Superior Iliac Spine (PSIS)- Trochanter Major (TM) [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

  3. PSIS-Ischial Tuberosity (IT) [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

  4. IT-TM [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

  5. Sacrum-TM [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

For Piriformis syndrome group (study group);

Inclusion Criteria:
  • A dramatic relief of pain following piriformis muscle local anesthetic injection
Exclusion Criteria:
  • 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

Inclusion criteria:

-Having Anteroposterior pelvic radiographs for other medical reasons

Exclusion criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fatih Sultan Mehmet Research and Traning Hospital Istanbul Turkey 34752

Sponsors and Collaborators

  • Fatih Sultan Mehmet Training and Research Hospital

Investigators

  • Study Director: Gamze Güleç, MD, Fatih Sultan Mehmet Training and Research Hospital
  • Study Director: Ilknur Aktas, MD, Fatih Sultan Mehmet Training and Research Hospital
  • Study Chair: Feyza Unlu Ozkan, MD, Fatih Sultan Mehmet Training and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Fatih Sultan Mehmet Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04600024
Other Study ID Numbers:
  • FSMEAH
First Posted:
Oct 23, 2020
Last Update Posted:
Oct 23, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fatih Sultan Mehmet Training and Research Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2020