Chronic PainNCT05450913
Frequency of Piriformis Syndrome:Does the Presence of One Pathology Rule Out the Other?
A study testing Priformis intramuscular injection with %2 lidocain in people with Chronic Pain, run by Diskapi Teaching and Research Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Priformis intramuscular injection with %2 lidocain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 10 Jul 2022to 15 Jul 2022
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with unilateral hip and/or leg pain
Who cannot join
- no
About this study
Official title: Frequency of Piriformis Syndrome in Hip and/or Leg Pain: Does the Presence of One Pathology Rule Out the Other?
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Priformis intramuscular injection with %2 lidocain
- Keywords
- piriformis syndrome, myofascial pain, ultrasound guidance, trigger point injection
- Medical subject headings
- Chronic Pain, Piriformis Muscle Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Priformis intramuscular injection with %2 lidocainDrug
Also called pyriformis intramuscular injection or diagnostic test with local anesthetic
Priformis intramuscular injection will be administered with 5 cc 2% lidocaine, accompanied by a nerve stimulator under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| patients with unilateral hip and leg pain | Other | 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. Receives: Drug: Priformis intramuscular injection with %2 lidocain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2022
- Study start10 Jul 2022 (estimated)
- Primary completion15 Jul 2022 (estimated)
- Study completion15 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Damla Yürük, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450913
- Sponsor's protocol ID
- piriformis
- Status last verified
- Jul 2022
- First submitted
- 21 Mar 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Piriformis Syndrome in Hip and/or Leg Pain: Does the Presence of One Pathology Rule Out the Other?
- ClinicalTrials.gov ID
- NCT05450913
- Acronym / sponsor ID
- piriformis
- Conditions
- Chronic Pain
- Keywords
- piriformis syndrome, myofascial pain, ultrasound guidance, trigger point injection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 10 Jul 2022 (estimated)
- Primary completion
- 15 Jul 2022 (estimated)
- Study completion
- 15 Jul 2022 (estimated)
- First posted
- 11 Jul 2022 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with unilateral hip and leg pain | Other | Drug: Priformis intramuscular injection with %2 lidocainMusculoskeletal 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients presenting with unilateral hip and/or leg pain
Key exclusion criteria (1 listed)
- no
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 |
|---|---|---|
| Priformis intramuscular injection with %2 lidocainAlso: pyriformis intramuscular injection or diagnostic test with local anestheticPriformis intramuscular injection will be administered with 5 cc 2% lidocaine, accompanied by a nerve stimulator under ultrasound guidance | Drug | patients with unilateral hip and leg pain |
Primary outcome
To determine the frequency of Priformis syndrome
Time frame: 1 months
Change in Pain Scores on Visual Analogue Scale scores at 24 hours before and after Priformis muscule injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Priformis intramuscular injection with %2 lidocain in people with Chronic Pain, run by Diskapi Teaching and Research Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
To determine the frequency of Priformis syndrome (time frame: 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jul 2022.