Myofascial Trigger Point PainPhase 4NCT05792111
Caudal Epidural Steroid and Trigger Point Injection
A Phase 4 study testing Trigger point injection (lidocaine) and Caudal epidural Group (bupivacaine + triamcinolone + NaCl) in people with Myofascial Trigger Point Pain, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
This prospective randomized study will be conducted in Bolu Abant İzzet Baysal University Hospital. Chronic low back and hip pain 72 patients aged between 18-70 years will be included in the study. The primary output of our study was NRS scores. The study of Manchikanti. L et al. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Myofascial Trigger Point Pain
- What is being tested?
- Trigger point injection (lidocaine) and Caudal epidural Group (bupivacaine + triamcinolone + NaCl)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Oct 2022to 20 Dec 2024
- Phase
- Phase 4
- 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
- Low back or leg pain that has been going on for at least 2 months,
- Patients between the ages of 18-70,
- Disc herniation or radiculopathy in lumbar MRI examination .To be mentally competent to understand and evaluate NRS, ODI, and SF-36 forms.
Who cannot join
- Being pregnant or lactating,
- Presence of spinal canal stenosis,
- The presence of bleeding diathesis,
- Presence of disease with progressive neurological deficit,
- The presence of serious psychiatric illness,
- Presence of progressive neurological deficit or incontinence,
Show all 11Show fewer
- Having an epidural steroid injection in the last 6 months, Having uncontrolled diabetes mellitus Having hypertension,
- Known history of allergy to local anesthetics or corticosteroids,
- The patient does not want treatment,
- Local infection at the injection site,
- Infections such as discitis, spondylodiscitis, and sacroiliitis.
Trial locations and contacts
1 site in 1 country.
murat bilgi, prof.dr contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Abant Izzet Baysal University Medical School,
Bolu, 14280
Murat Bilgi, MD, 5053745059, drmuratbilgi@gmail.com
About this study
Official title: Analgesic Effects of Trigger Point Injection Added to Caudal Epidural Steroid
This prospective randomized study will be conducted in Bolu Abant İzzet Baysal University Hospital. Chronic low back and hip pain 72 patients aged between 18-70 years will be included in the study. The primary output of our study was NRS scores. The study of Manchikanti. L et al. (control group NRS reduction 4.4 ± 1.8; α margin of error 0.05, power 99%) (3) was taken as the basis for determining the sample size. Using the G Power 3 calculator program, 72 patients were identified to reduce their NRS scores by 25%. With a 20% exclusion rate, the total number of patients was calculated as 90
Read the detailed description
Demographic information of all patients included in the study; name, surname, telephone number, age, gender, educational status, profession, and marital status will be recorded. The duration of the pain, the onset of the pain, the accompanying leg pain, the activities that increase or decrease the pain, the presence of neurological symptoms, the analgesic agents used in the last week, and the previous treatments will be noted. Lumbar MRI findings and the level of pathology causing low back and hip pain will be recorded. History, family history, comorbidities (hypertension, diabetes mellitus, hyperlipidemia, cardiac disease, hypothyroidism), and detailed physical examinations of the patients will be recorded. Examinations of the patients before and 3, 6, and 12 weeks after the injection will be performed, and NRS scores at 3 and 6 weeks. The procedures will be repeated for patients who are over 4 years old. During the pre-procedural evaluation, the patients will be informed about the study, information about the Numeric Rating Score (NRS), Oswestry Disability Index (ODI), Short Form-36 (SF-36) to be used for post-procedure analgesia, and both verbal and written consents will be obtained. The staff who will make the evaluation will not know which group the patients belong to, and the study will be blinded.
- Conditions
- Myofascial Trigger Point Pain
- Being tested
- Trigger point injection (lidocaine), Caudal epidural Group (bupivacaine + triamcinolone + NaCl)
- Keywords
- Caudal Epidural Steroid Injection, Trigger Point Injection, NRS score
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trigger point injection (lidocaine)Drug
Also called lidocaine
trigger point injection will be added to the gluteus medius and minimus muscles in addition to caudal epidural steroid injection.
Caudal epidural Group (bupivacaine + triamcinolone + NaCl)Drug
Also called triamsinolon asetonid
It will be advanced towards the sacral hiatus and local anesthesia of the skin and subcutaneous tissue will be provided with 2% lidocaine. The caudal epidural space will be entered by puncturing the sacrococcygeal ligament with the tip of a 22 G black needle from the appropriate area and taking a pop sensation. It will be confirmed that there is no bleeding or cerebrospinal fluid in this area by applying saline in real-time sonography and after the caudal epidural spread is observed, aspiration is performed. Afterward, a 10 mL volume of bupivacaine 4cc/20mg+ triamcinolone 2cc/80mg+0.09% NaCl 4cc mixture will be administered into the caudal epidural space
| Study group | Role | What they receive |
|---|---|---|
| Group C | Experimental | Group C; caudal epidural steroid injection (10 mL volume of bupivacaine 4cc/20mg+ triamcinolone 2cc/80mg+0.09% NaCl 4cc mixture will be administered into the caudal epidural space). Receives: Drug: Caudal epidural Group (bupivacaine + triamcinolone + NaCl) |
| Group CT | Active comparator | Group CT; trigger point injection will be added to the gluteus medius and minimus muscles in addition to caudal epidural steroid injection. Receives: Drug: Trigger point injection (lidocaine); Drug: Caudal epidural Group (bupivacaine + triamcinolone + NaCl) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) score
NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain
Measured: basaline,
Numerical Rating Scale (NRS) score
NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain
Measured: after ESİ 3 weeks,
Numerical Rating Scale (NRS) score
NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain
Measured: after ESİ 6 weeks
Numerical Rating Scale (NRS) score
NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain
Measured: after ESİ12 weeks
Secondary outcomes (8)
Oswestry Disability Index
used to qualify low back pain.(range 0 to 100).Zero is equated with no disability and 100 is the maximum disability possible
Measured: basaline
Oswestry Disability Index
used to qualify low back pain.(range 0 to 100).Zero is equated with no disability and 100 is the maximum disability possible
Measured: after ESİ 3 weeks
Oswestry Disability Index
used to qualify low back pain.(range 0 to 100).Zero is equated with no disability and 100 is the maximum disability possible
Measured: after ESİ 6 weeks
Oswestry Disability Index
used to qualify low back pain.(range 0 to 100).Zero is equated with no disability and 100 is the maximum disability possible
Measured: after ESİ12 weeks
Short Form-36
used to measure of patient's health status.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: basaline
Short Form-36
used to measure of patient's health status.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: after ESİ 3 weeks,
Short Form-36
used to measure of patient's health status.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: ,after ESİ 6 weeks
Short Form-36
used to measure of patient's health status.The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: after ESİ12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start12 Oct 2022
- Primary completion20 Dec 2023 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Trigger Point 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Trigger point injection was added to the gluteus medius and gluteus Maximus muscles in addition to caudal epidural steroids.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Bilgi, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792111
- Sponsor's protocol ID
- AİBU-Med-MB-01
- Status last verified
- Mar 2023
- First submitted
- 18 Oct 2022
- Last updated
- 31 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effects of Trigger Point Injection Added to Caudal Epidural Steroid
- ClinicalTrials.gov ID
- NCT05792111
- Acronym / sponsor ID
- AİBU-Med-MB-01
- Conditions
- Myofascial Trigger Point Pain
- Keywords
- Caudal Epidural Steroid Injection, Trigger Point Injection, NRS score
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 31 Mar 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.
This prospective randomized study will be conducted in Bolu Abant İzzet Baysal University Hospital. Chronic low back and hip pain 72 patients aged between 18-70 years will be included in the study. The primary output of our study was NRS scores. The study of Manchikanti. L et al. (control group NRS reduction 4.4 ± 1.8; α margin of error 0.05, power 99%) (3) was taken as the basis for determining the sample size. Using the G Power 3 calculator program, 72 patients were identified to reduce their NRS scores by 25%. With a 20% exclusion rate, the total number of patients was calculated as 90
Detailed description
Demographic information of all patients included in the study; name, surname, telephone number, age, gender, educational status, profession, and marital status will be recorded. The duration of the pain, the onset of the pain, the accompanying leg pain, the activities that increase or decrease the pain, the presence of neurological symptoms, the analgesic agents used in the last week, and the previous treatments will be noted. Lumbar MRI findings and the level of pathology causing low back and hip pain will be recorded. History, family history, comorbidities (hypertension, diabetes mellitus, hyperlipidemia, cardiac disease, hypothyroidism), and detailed physical examinations of the patients will be recorded. Examinations of the patients before and 3, 6, and 12 weeks after the injection will be performed, and NRS scores at 3 and 6 weeks. The procedures will be repeated for patients who are over 4 years old. During the pre-procedural evaluation, the patients will be informed about the study, information about the Numeric Rating Score (NRS), Oswestry Disability Index (ODI), Short Form-36 (SF-36) to be used for post-procedure analgesia, and both verbal and written consents will be obtained. The staff who will make the evaluation will not know which group the patients belong to, and the study will be blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Trigger point injection was added to the gluteus medius and gluteus Maximus muscles in addition to caudal epidural steroids.
| Arm | Type | Receives |
|---|---|---|
| Group C | Experimental | Drug: Caudal epidural Group (bupivacaine + triamcinolone + NaCl)Group C; caudal epidural steroid injection (10 mL volume of bupivacaine 4cc/20mg+ triamcinolone 2cc/80mg+0.09% NaCl 4cc mixture will be administered into the caudal epidural space). |
| Group CT | Active comparator | Drug: Trigger point injection (lidocaine), Drug: Caudal epidural Group (bupivacaine + triamcinolone + NaCl)Group CT; trigger point injection will be added to the gluteus medius and minimus muscles in addition to caudal epidural steroid injection. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Low back or leg pain that has been going on for at least 2 months,
- Patients between the ages of 18-70,
- Disc herniation or radiculopathy in lumbar MRI examination .To be mentally competent to understand and evaluate NRS, ODI, and SF-36 forms.
Key exclusion criteria (11 listed)
- Being pregnant or lactating,
- Presence of spinal canal stenosis,
- The presence of bleeding diathesis,
- Presence of disease with progressive neurological deficit,
- The presence of serious psychiatric illness,
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 |
|---|---|---|
| Trigger point injection (lidocaine)Also: lidocainetrigger point injection will be added to the gluteus medius and minimus muscles in addition to caudal epidural steroid injection. | Drug | Group CT |
| Caudal epidural Group (bupivacaine + triamcinolone + NaCl)Also: triamsinolon asetonidIt will be advanced towards the sacral hiatus and local anesthesia of the skin and subcutaneous tissue will be provided with 2% lidocaine. The caudal epidural space will be entered by puncturing the sacrococcygeal ligament with the tip of a 22 G black needle from the appropriate area and taking a pop sensation. It will be confirmed that there is no bleeding or cerebrospinal fluid in this area by applying saline in real-time sonography and after the caudal epidural spread is observed, aspiration is performed. Afterward, a 10 mL volume of bupivacaine 4cc/20mg+ triamcinolone 2cc/80mg+0.09% NaCl 4cc mixture will be administered into the caudal epidural space | Drug | Group C, Group CT |
Primary outcome
Numerical Rating Scale (NRS) score
Time frame: basaline,
NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain
Numerical Rating Scale (NRS) score
Time frame: after ESİ 3 weeks,
NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain
Numerical Rating Scale (NRS) score
Time frame: after ESİ 6 weeks
NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain
Numerical Rating Scale (NRS) score
Time frame: after ESİ12 weeks
NRS score measures a patient's pain intensity. For example, (range 0-10) where 0 is no pain and 10 is the worst pain
8 secondary outcomes
Oswestry Disability Index
Time frame: basaline
Oswestry Disability Index
Time frame: after ESİ 3 weeks
Oswestry Disability Index
Time frame: after ESİ 6 weeks
Oswestry Disability Index
Time frame: after ESİ12 weeks
Short Form-36
Time frame: basaline
Short Form-36
Time frame: after ESİ 3 weeks,
Short Form-36
Time frame: ,after ESİ 6 weeks
Short Form-36
Time frame: after ESİ12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No
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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.
murat bilgi, prof.dr contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Trigger point injection (lidocaine) and Caudal epidural Group (bupivacaine + triamcinolone + NaCl) in people with Myofascial Trigger Point Pain, run by Abant Izzet Baysal University 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 3 inclusion and 11 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 31 Mar 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 murat bilgi, prof.dr (+90505 374 50 59, drmuratbilgi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Rating Scale (NRS) score (time frame: basaline,). The study lists 4 primary outcomes in all. 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 31 Mar 2023.