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The Importance of Gluteus Maximus Muscle in Patients With Preliminary Diagnosis of Piriformis Syndrome

Primary Purpose

Piriformis Muscle Syndrome, Myofacial Pain Syndromes, Piriformis Syndrome

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound guided piriformis muscle and gluteus maximus muscle lidocaine injection
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Piriformis Muscle Syndrome focused on measuring Piriformis Muscle Syndrome, Myofacial Pain Syndrome, Ultrasonography, Gluteus Maximus Muscle

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged 18-65 years
  • Had unilateral hip pain and/or leg pain
  • Had Positive trigger point or taut band or pain with pression in piriformis muscle
  • Patients whose informed consent was obtained for participation in the study

Exclusion Criteria:

  • History of hip surgery
  • History of spinal surgery
  • Clinical diagnosis of Inflammatory rheumatic diseases
  • History of spinal or pelvic fracture
  • Clinical diagnosis of osteoarthritis or history of fracture of the lower extremities
  • Had uncontrolled diabetes
  • Pregnancy or breastfeeding
  • Had allergy to lidocaine
  • Had gluteal injection in the previous 6 months
  • Had anticoagulant or antiplatelet treatment
  • Had skin infection at the site of needle entry
  • Had radiculopathy caused by lumbar disc pathology
  • Had neurological disease
  • Tumors

Sites / Locations

  • Istanbul University- Cerrahpaşa

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Gluteus Maximus Group

Piriformis Muscle group

Arm Description

30 patients in the gluteus maximus group will be evaluated with detailed physical examination and special clinical tests. Sensitivity with sonopalpation, piriformis and gluteus maximus thicknesses, echo intensities will be evaluated with ultrasonography. Primarily diagnostic injection test for gluteus maximus muscle is planned for the first group with lidocaine with USG guide. At the first hour after injection full examination will be repeated for all patient and will be evaluated again with Numeric Rating Scale(NRS) at rest, with movement and with deep palpation. If the NRS score persists after the first injection patients will receive a diagnostic lidocaine injection into the piriformis muscle. At the first hour after the second injection, the physical examination and clinical tests of the patients will be repeated, and their pain at rest, with movement and with deep palpation will be evaluated with NRS.

30 patients in the piriformis muscle group will be evaluated with detailed physical examination and special clinical tests. Sensitivity with sonopalpation, piriformis and gluteus maximus thicknesses, echo intensities will be evaluated with ultrasonography. Primarily diagnostic injection test for piriformis muscle (piriformis syndrome) is planned for the first group with lidocaine with USG guide. At the first hour after injection full examination will be repeated for all patient and will be evaluated again with Numeric Rating Scale(NRS) at rest, with movement and with deep palpation. If the NRS score persists after the first injection patients will receive a diagnostic lidocaine injection into the gluteus Maximus muscle. At the first hour after the second injection, the physical examination and clinical tests of the patients will be repeated, and their pain at rest, with movement and with deep palpation will be evaluated with NRS.

Outcomes

Primary Outcome Measures

Change from Baseline Pain via Numeric Rating Scale at 60 Minutes after piriformis muscle/gluteus maximus Injection (first injection)
Pain of the participants will be assessed by one of the most commonly used pain scale "numerical rating scale". It is numeric version of visual analog scale in which a patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine". Participant is asked to indicate rates of their pain on the day of presentation during resting, during function and physical examination as a baseline and, 60 minutes after gluteus maximus injection for each, 60 minutes after piriformis muscle injection for each.

Secondary Outcome Measures

Change from Baseline Pain via Numeric Rating Scale at 60 Minutes after Second Injection
Pain of the participants will be assessed by one of the most commonly used pain scale "numerical rating scale". It is numeric version of visual analog scale in which a patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine". Participant is asked to indicate rates of their pain on the day of presentation during resting, during function and physical examination as a baseline and, 60 minutes after gluteus maximus injection for each, 60 minutes after piriformis muscle injection for each.

Full Information

First Posted
February 18, 2022
Last Updated
June 26, 2022
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT05271071
Brief Title
The Importance of Gluteus Maximus Muscle in Patients With Preliminary Diagnosis of Piriformis Syndrome
Official Title
The Importance of Gluteus Maximus Muscle in Patients With Preliminary Diagnosis of Piriformis Syndrome: Prospective, Randomized, Single-Blind, Crossover Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
March 14, 2022 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
May 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Literature shows different pathologies or combination pathologies can cause gluteal region pain and it can be difficult to diagnose. Piriformis syndrome is one of the cause of gluteal region pain, symptoms of myofascial pain syndrome affected gluteus maximus muscle may masquerade as piriformis muscle syndrome or both syndrome can be seen together. The aim of this study is diagnosis myofascial pain syndrome of gluteus maximus muscle and piriformis syndrome by physical examination, special clinical tests and ultrasound guided diagnostic injection test in patients presenting with gluteal pain and evaluate the coexistence of both syndromes.
Detailed Description
Piriformis syndrome is a painful clinical picture caused by entrapment of the sciatic nerve by the piriformis muscle at the exit of the pelvis, which causes pain in the gluteal region. It is characterized by symptoms of pain and numbness radiating from the thigh to the leg along the hip and sciatic trace. Compression/irritation of the sciatic nerve in or around the piriformis muscle constitutes the neuropathic component of the syndrome. Myofascial pain of the piriformis muscle is the primary cause of the somatic component of the syndrome. Various causes have been reported: congenital anomalies of piriformis muscle or sciatic nerve, trauma, overuse, muscle hypertrophy, shortening of the muscle, infection within the muscle, and leg length discrepancy. History, physical examination and ultrasound guided diagnostic injection test are key elements for the diagnosis. Another cause of pain in the gluteal region is myofascial pain syndrome of gluteus maximus muscle. Myofascial pain syndrome is a largely underdiagnosed and undertreated entity. Prevalence varies from 30 to 93% among the persons with musculoskeletal pain. Myofascial pain syndrome is a syndrome characterized by acute or chronic regional pain originating from localized trigger points in the muscle and fascia. Traumatic events, muscular overloads, psychological stress, and systemic pathology may lead to development of one or more palpable bands or trigger points. Myofascial pain syndrome affecting the gluteus maximus muscle causes pain in the medial and lower parts of the muscle; It is characterized by pain that usually radiates throughout the hip and sometimes into the coccygeal region. The diagnosis of myofascial pain syndrome is based on a pertinent history and physical examination. The purpose of the study is; to evaluate the myofascial pain syndrome of gluteus maximus muscle and piriformis syndrome with physical examination, special clinical tests, ultrasonographic examinations and, to confirm the presence of myofascial pain syndrome of gluteus maximus muscle accompanying piriformis syndrome with the evaluation of clinical findings after the gluteus maximus and piriformis muscle diagnostic injections.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Piriformis Muscle Syndrome, Myofacial Pain Syndromes, Piriformis Syndrome
Keywords
Piriformis Muscle Syndrome, Myofacial Pain Syndrome, Ultrasonography, Gluteus Maximus Muscle

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gluteus Maximus Group
Arm Type
Active Comparator
Arm Description
30 patients in the gluteus maximus group will be evaluated with detailed physical examination and special clinical tests. Sensitivity with sonopalpation, piriformis and gluteus maximus thicknesses, echo intensities will be evaluated with ultrasonography. Primarily diagnostic injection test for gluteus maximus muscle is planned for the first group with lidocaine with USG guide. At the first hour after injection full examination will be repeated for all patient and will be evaluated again with Numeric Rating Scale(NRS) at rest, with movement and with deep palpation. If the NRS score persists after the first injection patients will receive a diagnostic lidocaine injection into the piriformis muscle. At the first hour after the second injection, the physical examination and clinical tests of the patients will be repeated, and their pain at rest, with movement and with deep palpation will be evaluated with NRS.
Arm Title
Piriformis Muscle group
Arm Type
Active Comparator
Arm Description
30 patients in the piriformis muscle group will be evaluated with detailed physical examination and special clinical tests. Sensitivity with sonopalpation, piriformis and gluteus maximus thicknesses, echo intensities will be evaluated with ultrasonography. Primarily diagnostic injection test for piriformis muscle (piriformis syndrome) is planned for the first group with lidocaine with USG guide. At the first hour after injection full examination will be repeated for all patient and will be evaluated again with Numeric Rating Scale(NRS) at rest, with movement and with deep palpation. If the NRS score persists after the first injection patients will receive a diagnostic lidocaine injection into the gluteus Maximus muscle. At the first hour after the second injection, the physical examination and clinical tests of the patients will be repeated, and their pain at rest, with movement and with deep palpation will be evaluated with NRS.
Intervention Type
Diagnostic Test
Intervention Name(s)
Ultrasound guided piriformis muscle and gluteus maximus muscle lidocaine injection
Other Intervention Name(s)
Ultrasound guided piriformis muscle (piriformis syndrome) and gluteus maximus muscle (myofacial pain syndrome of gluteus Maximus muscle) diagnostic lidocaine injection
Intervention Description
Ultrasound guided piriformis muscle (piriformis syndrome) and gluteus maximus muscle 5 ml %1 lidocaine injection
Primary Outcome Measure Information:
Title
Change from Baseline Pain via Numeric Rating Scale at 60 Minutes after piriformis muscle/gluteus maximus Injection (first injection)
Description
Pain of the participants will be assessed by one of the most commonly used pain scale "numerical rating scale". It is numeric version of visual analog scale in which a patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine". Participant is asked to indicate rates of their pain on the day of presentation during resting, during function and physical examination as a baseline and, 60 minutes after gluteus maximus injection for each, 60 minutes after piriformis muscle injection for each.
Time Frame
Baseline, 60 minutes after gluteus maximus injection, 60 minutes after piriformis muscle injection.
Secondary Outcome Measure Information:
Title
Change from Baseline Pain via Numeric Rating Scale at 60 Minutes after Second Injection
Description
Pain of the participants will be assessed by one of the most commonly used pain scale "numerical rating scale". It is numeric version of visual analog scale in which a patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine". Participant is asked to indicate rates of their pain on the day of presentation during resting, during function and physical examination as a baseline and, 60 minutes after gluteus maximus injection for each, 60 minutes after piriformis muscle injection for each.
Time Frame
Baseline, 60 minutes after gluteus maximus injection, 60 minutes after piriformis muscle injection.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 18-65 years Had unilateral hip pain and/or leg pain Had Positive trigger point or taut band or pain with pression in piriformis muscle Patients whose informed consent was obtained for participation in the study Exclusion Criteria: History of hip surgery History of spinal surgery Clinical diagnosis of Inflammatory rheumatic diseases History of spinal or pelvic fracture Clinical diagnosis of osteoarthritis or history of fracture of the lower extremities Had uncontrolled diabetes Pregnancy or breastfeeding Had allergy to lidocaine Had gluteal injection in the previous 6 months Had anticoagulant or antiplatelet treatment Had skin infection at the site of needle entry Had radiculopathy caused by lumbar disc pathology Had neurological disease Tumors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bilge Cakir
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kenan Akgun
Organizational Affiliation
Istanbul University - Cerrahpasa (IUC)
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University- Cerrahpaşa
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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31102324
Citation
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The Importance of Gluteus Maximus Muscle in Patients With Preliminary Diagnosis of Piriformis Syndrome

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