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Frequency of Piriformis Syndrome:Does the Presence of One Pathology Rule Out the Other?

Primary Purpose

Chronic Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Priformis intramuscular injection with %2 lidocain
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring piriformis syndrome, myofascial pain, ultrasound guidance, trigger point injection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients presenting with unilateral hip and/or leg pain

Exclusion Criteria:

  • no

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    patients with unilateral hip and leg pain

    Arm Description

    Musculoskeletal system examination, neurological examination, visual analog scale (VAS) score and DN4 (Douleur Neuropathique 4 Questions) of patients presenting with unilateral hip and/or leg pain, 3 tests frequently used in the diagnosis of priformis (Freiberg test, Pace sign, FADIR) ) will be applied. Patients with suspected priformis syndrome will be given an intramuscular injection If the pain intensity decreases by 50% or more after the intramuscular injection, the diagnosis of piriformis will be made.

    Outcomes

    Primary Outcome Measures

    To determine the frequency of Priformis syndrome
    Change in Pain Scores on Visual Analogue Scale scores at 24 hours before and after Priformis muscule injection

    Secondary Outcome Measures

    Full Information

    First Posted
    March 21, 2022
    Last Updated
    July 8, 2022
    Sponsor
    Diskapi Teaching and Research Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05450913
    Brief Title
    Frequency of Piriformis Syndrome:Does the Presence of One Pathology Rule Out the Other?
    Official Title
    Frequency of Piriformis Syndrome in Hip and/or Leg Pain: Does the Presence of One Pathology Rule Out the Other?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 10, 2022 (Anticipated)
    Primary Completion Date
    July 15, 2022 (Anticipated)
    Study Completion Date
    July 15, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Diskapi Teaching and Research Hospital

    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
    The purpose of the investigators is to determine the frequency of priformis syndrome in patients presenting with hip and/or leg pain and to investigate the association of Priformis syndrome with other pathologies of the lumbar spine and hip.
    Detailed Description
    Priformis Syndrome is a neuromuscular disorder characterized by compression or irritation of the sciatic nerve under the piriformis muscle, tenderness in the piriformis muscle, and back, hip, and leg pain. The pain may radiate along the sciatic nerve trace in the gluteal region and posterior thigh. Diagnosis is based on clinical symptoms, specific physical examination findings, and positive response to local injection. The diagnosis of piriformis syndrome is usually made only after lumbar spine pathologies are excluded. This traditional approach leads to underdiagnosis of piriformis syndrome. More than one cause may coexist in hip and/or leg pain.The existence of one cause does not exclude the other.Priformis syndrome should not be a diagnosis of exclusion. In the differential diagnosis of hip and/or leg pain, physical examination to exclude piriformis syndrome and injection of local anesthetic into the piriformis muscle is much less invasive than surgery to confirm lumbar spine pathology and can be performed as an outpatient.Thus, early diagnosis and appropriate treatment process is accelerated. If there is an unfavorable response to the local injection, investigation for lumbar vertebral pathologies can be initiated. The purpose of the investigators under this information and justifications is; To determine the frequency of Priformis syndrome in patients presenting with hip and/or leg pain and to investigate the association of Priformis syndrome with other pathologies of the lumbar spine and hip.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Pain
    Keywords
    piriformis syndrome, myofascial pain, ultrasound guidance, trigger point injection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    patients with unilateral hip and leg pain
    Arm Type
    Other
    Arm Description
    Musculoskeletal system examination, neurological examination, visual analog scale (VAS) score and DN4 (Douleur Neuropathique 4 Questions) of patients presenting with unilateral hip and/or leg pain, 3 tests frequently used in the diagnosis of priformis (Freiberg test, Pace sign, FADIR) ) will be applied. Patients with suspected priformis syndrome will be given an intramuscular injection If the pain intensity decreases by 50% or more after the intramuscular injection, the diagnosis of piriformis will be made.
    Intervention Type
    Drug
    Intervention Name(s)
    Priformis intramuscular injection with %2 lidocain
    Other Intervention Name(s)
    pyriformis intramuscular injection or diagnostic test with local anesthetic
    Intervention Description
    Priformis intramuscular injection will be administered with 5 cc 2% lidocaine, accompanied by a nerve stimulator under ultrasound guidance
    Primary Outcome Measure Information:
    Title
    To determine the frequency of Priformis syndrome
    Description
    Change in Pain Scores on Visual Analogue Scale scores at 24 hours before and after Priformis muscule injection
    Time Frame
    1 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients presenting with unilateral hip and/or leg pain Exclusion Criteria: no

    12. IPD Sharing Statement

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    Frequency of Piriformis Syndrome:Does the Presence of One Pathology Rule Out the Other?

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