Piriformis SyndromeNCT06130618
The Effects of Ultrasound Guided Ozone and Lidocaine Injections in Piriformis Syndrome
A study testing Ozone and Lidocain in people with Piriformis Syndrome, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Piriformis Syndrome (PS) is defined as a trap neuropathy that involves compression of the sciatic nerve by the piriformis muscle, leading to a number of symptoms along with sciatic pain, initially in the hip muscles. In clinical practice, it is estimated to be between 12.2-27%. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Piriformis Syndrome
- What is being tested?
- Ozone and Lidocain
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 1 Mar 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age
- Patients with pain in the posterior aspect of the thigh and diagnosed with piriformis through physical examination and special tests
- Knowing how to read and write Turkish
- Patients with visual analog scale ≥5
Who cannot join
- Those with a history of lumbar discopathy or a history of discopathy surgery
- BMI over ≥ 30
- Having had a corticosteroid injection within the last 3 months
- Presence of neurological deficit in the lower extremity
- Having a history of previous hip surgery
- Having progressive or non-progressive central and peripheral nervous system disease,
- Patients in pregnancy and lactation
- Use of anticoagulants
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ankara Bilkent City Hospital
Ankara, 06800
Bilge Kesikburun, Ass. Professor, +903125526000, drbilgekb@gmail.com
About this study
Official title: The Effects of Ultrasound Guided Ozone and Lidocaine Injections on Pain, Functional Level and Posture in Piriformis Syndrome
Piriformis Syndrome (PS) is defined as a trap neuropathy that involves compression of the sciatic nerve by the piriformis muscle, leading to a number of symptoms along with sciatic pain, initially in the hip muscles. In clinical practice, it is estimated to be between 12.2-27%.
Repetitive movements with increased demand on the piriformis muscle can lead to increased muscle tension, compression of the sciatic nerve within the muscle, and the development of PS. Additionally, the anatomical structure of the piriformis muscle and the alignment and damage of adjacent structures play a role in the pathophysiology of sciatic nerve compression in PS. It is considered in pathophysiology that a morphological change (contracture, hypertrophy) may cause compression of the sciatic nerve or the relationships of different anatomical structures that change with biomechanical restrictions.
Read more
Pain is observed along the ipsilateral sciatic nerve distribution due to compression of the sciatic nerve. Additionally, it has been observed that patients with PS are accompanied by weakness in the gluteal muscles, mostly in the gluteus maximus and medius muscles. Accompanying weakness has an effect on static and dynamic posture (2,3). The negative effect of pain on posture has also been shown in studies (4). Pain and muscle changes in the lower extremities also cause disability and postural instability. It has been reported that static and dynamic postural balance is reduced in PS compared to healthy controls (1).
Conservative treatment for PS significantly reduces pain with a wide range of therapeutic alternatives. Since ozone injection does not have side effects or major complications, its use in the treatment of myofascial pain syndromes and piriformis syndrome is supported by studies (5). It has an analgesic effect, increasing the pain threshold by activating serotonin-mediated pathways to release endogenous opioids. Additionally, it is used safely due to its low side effect profile. In the literature, it has been shown that local anesthetic injection applications alone or in combination with steroids are effective in the treatment of PS alone due to the therapeutic effects of local anesthetic (6).
This study aimed to investigate the effects of ozone and local anesthetic injection on pain, functional level and posture in patients diagnosed with PS.
Read the detailed description
It was planned as a randomized controlled study. Patients diagnosed with Priformis Syndrome will be evaluated and their demographic data and examination information will be recorded.
Patients will be divided into 2 groups: ozone and lidocaine injections by computerized randomization. If there is a contraindication for ozone, the patient will be included in the lidocaine group, and similarly, if the patient has a contraindication for lidocaine, the patient will be included in the ozone group. According to G-power analysis, a total of 28 patients, 14 for each group, will be included in the study.
One group will be injected with 5 mL of lidocaine 2% after localizing the piriformis muscle with USG guidance, and the other group will be injected with 5 ml - 20 μg/mL ozone after localizing the piriformis muscle with USG guidance.
Pain levels of the patients will be evaluated with the visual analog scale at baseline, 1st Week, 1st Month and 3rd Month. Functional levels of all patients will be measured using the Lower Extremity Functional Scale; Posture evaluation includes trunk imbalance (sagittal/coronal imbalance), vertebral rotation, apical deviation, pelvic tilt, pelvic torsion, pelvic obliquity, kyphotic angle, lordotic angle measurement with DIERS 4D posture analyzer, static balance parameters with HUR balance device will be evaluated at baseline and at the 3rd month.
- Conditions
- Piriformis Syndrome
- Being tested
- Ozone, Lidocain
- Medical subject headings
- Piriformis Muscle Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OzoneOther
Also called Ozone injection
After localizing the piriformis muscle and sciatic nerve with ultrasound guidance, 5 ml - 20 μg/mL ozone will be injected.
LidocainDrug
Also called Lidocaine injection
After localizing the piriformis muscle and sciatic nerve with ultrasound guidance, 5 ml - 2% lidocaine will be injected.
| Study group | Role | What they receive |
|---|---|---|
| Ozone injection | Active comparator | After localizing the piriformis muscle with ultrasound guidance, 5 ml - 20 μg/mL ozone will be injected. Receives: Other: Ozone |
| Lidocaine injection | Active comparator | After localizing the piriformis muscle with ultrasound guidance, 5 ml - 2% lidocaine will be injected. Receives: Drug: Lidocain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain condition will evaluate by the visual analog scale
The Visual Analog Scale (VAS) pain score (on a range of 0-10, with 0 representing no pain and 10 representing the severe pain) will evaluate.
Measured: Baseline, 1. week, 1. month, 3. month
posture
Posture Analysis will be evaluated by DIERS formetric 4D. Participants will be positioned two meters away from the camera unit and formetric 4D projection. The device will project light stripes on the back of the participant. The back's surface will be captured on camera, converted to digital data, and displayed in three dimensions. Every scan will record 12-13 images over 6 seconds (2 Hz), and the manufacturer's recommendations will be followed for processing. Spinal reference points, measures of the spinal curve, distance and localization, imbalances of the trunk and pelvis, and spinal deviation will be measured. Spine shape parameters are expressed in millimeters, percentages, or degrees depending on the specific parameter.
Measured: Baseline, 3. month
Balance
The static and dynamic postural control were measured by the HUR SmartBalance BTG4 system (Hur Labs, Tampere, Finland). Participants were asked to stand barefoot on the balance platform, and were requested to stand as quietly as possible, without moving and looking forward, during the measurement. The stable floor was the platform's own floor, while the unstable floor was the foam cushion given by the manufacturer with the device. Data were collected for 30 seconds. The following parameters were calculated from the center of pressure (CoP) displacement time series for static postural control: sway area, trace length, velocity, Romberg, lateral sway, anterior-posterior sway. The limits of stability (LOS) were used to determine the dynamic postural control. The patients were asked to tilt their bodies forward, backward, leftward, and rightward for 8 seconds in each direction.
Measured: Baseline, 3. month
Secondary outcomes (1)
Function
The Lower Extremity Functional Scale (LEFS) is a set of 20 questions designed to assess an individual's capacity to carry out routine tasks. The highest possible score is 80. The lower the score means the higher the disability.
Measured: Baseline, 3. month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2023
- Study start1 Sep 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Piriformis SyndromeStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilge Kesikburun, Ankara City Hospital Bilkent
- Investigators
- Bilge Kesikburun, Ass. Prof, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06130618
- Sponsor's protocol ID
- E2-23-4633
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: When the study is completed study protocol and Clinical Study Report will be shared.
Publications
Jardak M, Chaari F, Bouchaala F, Fendri T, Harrabi MA, Rebai H, Sahli S. Does piriformis muscle syndrome impair postural balance? A case control study. Somatosens Mot Res. 2021 Dec;38(4):315-321. doi: 10.1080/08990220.2021.1973404. Epub 2021 Sep 14.
PubMed 34519264Chon J, Kim HS, Lee JH, Yoo SD, Yun DH, Kim DH, Lee SA, Han YJ, Soh Y, Kim Y, Han YR, Won CW, Han S. Association Between Asymmetry in Knee Extension Strength and Balance in a Community-Dwelling Elderly Population: A Cross-Sectional Analysis. Ann Rehabil Med. 2018 Feb;42(1):113-119. doi: 10.5535/arm.2018.42.1.113. Epub 2018 Feb 28.
PubMed 29560331Bouche K, Stevens V, Cambier D, Caemaert J, Danneels L. Comparison of postural control in unilateral stance between healthy controls and lumbar discectomy patients with and without pain. Eur Spine J. 2006 Apr;15(4):423-32. doi: 10.1007/s00586-005-1013-4. Epub 2005 Aug 18.
PubMed 16133081Misirlioglu 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.
PubMed 25794202
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ultrasound Guided Ozone and Lidocaine Injections on Pain, Functional Level and Posture in Piriformis Syndrome
- ClinicalTrials.gov ID
- NCT06130618
- Acronym / sponsor ID
- E2-23-4633
- Conditions
- Piriformis Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 14 Nov 2023 (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.
Piriformis Syndrome (PS) is defined as a trap neuropathy that involves compression of the sciatic nerve by the piriformis muscle, leading to a number of symptoms along with sciatic pain, initially in the hip muscles. In clinical practice, it is estimated to be between 12.2-27%.
Repetitive movements with increased demand on the piriformis muscle can lead to increased muscle tension, compression of the sciatic nerve within the muscle, and the development of PS. Additionally, the anatomical structure of the piriformis muscle and the alignment and damage of adjacent structures play a role in the pathophysiology of sciatic nerve compression in PS. It is considered in pathophysiology that a morphological change (contracture, hypertrophy) may cause compression of the sciatic nerve or the relationships of different anatomical structures that change with biomechanical restrictions.
Pain is observed along the ipsilateral sciatic nerve distribution due to compression of the sciatic nerve. Additionally, it has been observed that patients with PS are accompanied by weakness in the gluteal muscles, mostly in the gluteus maximus and medius muscles. Accompanying weakness has an effect on static and dynamic posture (2,3). The negative effect of pain on posture has also been shown in studies (4). Pain and muscle changes in the lower extremities also cause disability and postural instability. It has been reported that static and dynamic postural balance is reduced in PS compared to healthy controls (1).
Conservative treatment for PS significantly reduces pain with a wide range of therapeutic alternatives. Since ozone injection does not have side effects or major complications, its use in the treatment of myofascial pain syndromes and piriformis syndrome is supported by studies (5). It has an analgesic effect, increasing the pain threshold by activating serotonin-mediated pathways to release endogenous opioids. Additionally, it is used safely due to its low side effect profile. In the literature, it has been shown that local anesthetic injection applications alone or in combination with steroids are effective in the treatment of PS alone due to the therapeutic effects of local anesthetic (6).
This study aimed to investigate the effects of ozone and local anesthetic injection on pain, functional level and posture in patients diagnosed with PS.
Detailed description
It was planned as a randomized controlled study. Patients diagnosed with Priformis Syndrome will be evaluated and their demographic data and examination information will be recorded.
Patients will be divided into 2 groups: ozone and lidocaine injections by computerized randomization. If there is a contraindication for ozone, the patient will be included in the lidocaine group, and similarly, if the patient has a contraindication for lidocaine, the patient will be included in the ozone group. According to G-power analysis, a total of 28 patients, 14 for each group, will be included in the study.
One group will be injected with 5 mL of lidocaine 2% after localizing the piriformis muscle with USG guidance, and the other group will be injected with 5 ml - 20 μg/mL ozone after localizing the piriformis muscle with USG guidance.
Pain levels of the patients will be evaluated with the visual analog scale at baseline, 1st Week, 1st Month and 3rd Month. Functional levels of all patients will be measured using the Lower Extremity Functional Scale; Posture evaluation includes trunk imbalance (sagittal/coronal imbalance), vertebral rotation, apical deviation, pelvic tilt, pelvic torsion, pelvic obliquity, kyphotic angle, lordotic angle measurement with DIERS 4D posture analyzer, static balance parameters with HUR balance device will be evaluated at baseline and at the 3rd month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ozone injection | Active comparator | Other: OzoneAfter localizing the piriformis muscle with ultrasound guidance, 5 ml - 20 μg/mL ozone will be injected. |
| Lidocaine injection | Active comparator | Drug: LidocainAfter localizing the piriformis muscle with ultrasound guidance, 5 ml - 2% lidocaine will be injected. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over 18 years of age
- Patients with pain in the posterior aspect of the thigh and diagnosed with piriformis through physical examination and special tests
- Knowing how to read and write Turkish
- Patients with visual analog scale ≥5
Key exclusion criteria (8 listed)
- Those with a history of lumbar discopathy or a history of discopathy surgery
- BMI over ≥ 30
- Having had a corticosteroid injection within the last 3 months
- Presence of neurological deficit in the lower extremity
- Having a history of previous hip surgery
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 |
|---|---|---|
| OzoneAlso: Ozone injectionAfter localizing the piriformis muscle and sciatic nerve with ultrasound guidance, 5 ml - 20 μg/mL ozone will be injected. | Other | Ozone injection |
| LidocainAlso: Lidocaine injectionAfter localizing the piriformis muscle and sciatic nerve with ultrasound guidance, 5 ml - 2% lidocaine will be injected. | Drug | Lidocaine injection |
Primary outcome
Pain condition will evaluate by the visual analog scale
Time frame: Baseline, 1. week, 1. month, 3. month
The Visual Analog Scale (VAS) pain score (on a range of 0-10, with 0 representing no pain and 10 representing the severe pain) will evaluate.
posture
Time frame: Baseline, 3. month
Posture Analysis will be evaluated by DIERS formetric 4D. Participants will be positioned two meters away from the camera unit and formetric 4D projection. The device will project light stripes on the back of the participant. The back's surface will be captured on camera, converted to digital data, and displayed in three dimensions. Every scan will record 12-13 images over 6 seconds (2 Hz), and the manufacturer's recommendations will be followed for processing. Spinal reference points, measures of the spinal curve, distance and localization, imbalances of the trunk and pelvis, and spinal deviation will be measured. Spine shape parameters are expressed in millimeters, percentages, or degrees depending on the specific parameter.
Balance
Time frame: Baseline, 3. month
The static and dynamic postural control were measured by the HUR SmartBalance BTG4 system (Hur Labs, Tampere, Finland). Participants were asked to stand barefoot on the balance platform, and were requested to stand as quietly as possible, without moving and looking forward, during the measurement. The stable floor was the platform's own floor, while the unstable floor was the foam cushion given by the manufacturer with the device. Data were collected for 30 seconds. The following parameters were calculated from the center of pressure (CoP) displacement time series for static postural control: sway area, trace length, velocity, Romberg, lateral sway, anterior-posterior sway. The limits of stability (LOS) were used to determine the dynamic postural control. The patients were asked to tilt their bodies forward, backward, leftward, and rightward for 8 seconds in each direction.
1 secondary outcome
Function
Time frame: Baseline, 3. month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2023.
- Background: PubMed 34519264Jardak M, Chaari F, Bouchaala F, Fendri T, Harrabi MA, Rebai H, Sahli S. Does piriformis muscle syndrome impair postural balance? A case control study. Somatosens Mot Res. 2021 Dec;38(4):315-321. doi: 10.1080/08990220.2021.1973404. Epub 2021 Sep 14.
- Background: PubMed 29560331Chon J, Kim HS, Lee JH, Yoo SD, Yun DH, Kim DH, Lee SA, Han YJ, Soh Y, Kim Y, Han YR, Won CW, Han S. Association Between Asymmetry in Knee Extension Strength and Balance in a Community-Dwelling Elderly Population: A Cross-Sectional Analysis. Ann Rehabil Med. 2018 Feb;42(1):113-119. doi: 10.5535/arm.2018.42.1.113. Epub 2018 Feb 28.
- Background: PubMed 16133081Bouche K, Stevens V, Cambier D, Caemaert J, Danneels L. Comparison of postural control in unilateral stance between healthy controls and lumbar discectomy patients with and without pain. Eur Spine J. 2006 Apr;15(4):423-32. doi: 10.1007/s00586-005-1013-4. Epub 2005 Aug 18.
- Background: PubMed 25794202Misirlioglu 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.
- Individual participant dataSharing planned: Yes. When the study is completed study protocol and Clinical Study Report will be shared.
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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.
Bilge Kesikburun, Ass. Prof principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ozone and Lidocain in people with Piriformis Syndrome, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 4 inclusion and 8 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 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Bilge Kesikburun, Ass. Prof (0312 552 60 00, drbilgekb@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain condition will evaluate by the visual analog scale (time frame: Baseline, 1. week, 1. month, 3. month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06130618, which also lists 4 linked publications.
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 14 Nov 2023.