Coccyx InjuryNCT06242587
Impar VS Coccygeal Block in the Treatment of Coccidine
A study testing Pericoccygeal nerve block and Impar ganglion block in people with Coccyx Injury and Coccygeal Body Tumor, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to evaluate the efficacy of coccygeal nerve blockade. Impar sympathetic ganglion blockade is a common treatment method used in coccygeal pain. However, experience with the coccygeal nerve is scarce in the literature. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coccyx Injury, Coccygeal Body Tumor
- What is being tested?
- Pericoccygeal nerve block and Impar ganglion block
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Nov 2023to 19 May 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Coccygeal pain
Who cannot join
- Malignite
- Infection
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gevher Rabia Genç Perdecioğlu
Ankara, Çankaya, 06010
About this study
Official title: Comparison of Coccygeal Block and Impar Block for the Treatment of Coccydynia
The aim of this study was to evaluate the efficacy of coccygeal nerve blockade. Impar sympathetic ganglion blockade is a common treatment method used in coccygeal pain. However, experience with the coccygeal nerve is scarce in the literature. The investigator planned to follow up coccidynia patients who underwent impar sympathetic ganglion blockade and coccygeal nerve blockade for 3 months after the procedure. The investigator's aim is to compare the efficacy of coccygeal nerve blockade with impar blockade.
Read the detailed description
Patients with coccygeal pain will be evaluated. Patients with organic pathology such as malignancy and infection on imaging and investigations will be excluded. Seventy-four patients diagnosed with traumatic or idiopathic coccidynia will be included in the study. Patients will be randomised by computer programme. Half of them will undergo ultrasound-guided pericoccygeal nerve blockade and the other half will undergo fluoroscopy-guided impar sympathetic ganglion blockade. Pericoccygeal nerve block is performed with the patients lying in the prone position. The sacral horns are visualised using a linear probe. The coccygeal nerves are captured medial to the sacral cornuas and a combination of local anaesthetic and dexamethasone is injected. Impar sympathetic ganglion blockade It is performed in the operating theatre with the patient in the prone position. The sacrum and coccyx are visualised with a lateral view. A needle is inserted through the sacrococcygeal junction and a combination of local anaesthetic and dexamethasone is injected when an optimal image is obtained with contrast material injection. Patients will be evaluated before, 1 and 3 months after the procedure by filling out the Visual analogue scale and PARIS functional coxidynia questionnaire. The investigator who evaluates the patients and collects the data after the procedure will be blinded.
- Conditions
- Coccyx Injury, Coccygeal Body Tumor
- Being tested
- Pericoccygeal nerve block, Impar ganglion block
- Keywords
- Coccigodynia, Coccigeal pain treatment, Pericoccigeal nerve block, Impar ganglion block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pericoccygeal nerve blockDevice
The coccygeal corneas are visualised with a linear probe under ultrasound guidance. The pericoccygeal nerves are located medial to the cornu and a combination of local anaesthetic and dexamethasone is injected.
Impar ganglion blockProcedure or surgery
The sacrum is visualised with fluoroscopy. A needle is inserted through the sacrococcygeal junction. The optimal image is obtained by administering contrast material. A combination of local anaesthetic and dexamethasone is injected.
| Study group | Role | What they receive |
|---|---|---|
| Group Pericoccygeal block | Active comparator | Patients undergoing pericoccygeal block Receives: Device: Pericoccygeal nerve block |
| Group Impar ganglion block | Active comparator | Patients undergoing impar ganglion block Receives: Procedure: Impar ganglion block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analogue scale
A Visual Analogue Scale (VAS) is the pain rating scales. Numbers 0-10 represent the severity of the patients' pain. No pain : 0, Most severe pain : 10
Measured: Before treatment, week 4 and week 12
Secondary outcomes (1)
PARIS coccidini scale
Aims to measure functionality. There are options asking whether there is pain during movements such as sitting, standing, walking. the highest value is 10, the lowest value is 0
Measured: Before treatment, week 4 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2024
- Study start2 Nov 2023
- Primary completion18 Apr 2024 (estimated)
- Study completion19 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coccyx InjuryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 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
- NCT06242587
- Sponsor's protocol ID
- impar
- Status last verified
- Mar 2024
- First submitted
- 13 Jan 2024
- Last updated
- 12 Mar 2024
- 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 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Coccygeal Block and Impar Block for the Treatment of Coccydynia
- ClinicalTrials.gov ID
- NCT06242587
- Acronym / sponsor ID
- impar
- Conditions
- Coccyx Injury, Coccygeal Body Tumor
- Keywords
- Coccigodynia, Coccigeal pain treatment, Pericoccigeal nerve block, Impar ganglion block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 18 Apr 2024 (estimated)
- Study completion
- 19 May 2024 (estimated)
- First posted
- 5 Feb 2024 (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 aim of this study was to evaluate the efficacy of coccygeal nerve blockade. Impar sympathetic ganglion blockade is a common treatment method used in coccygeal pain. However, experience with the coccygeal nerve is scarce in the literature. The investigator planned to follow up coccidynia patients who underwent impar sympathetic ganglion blockade and coccygeal nerve blockade for 3 months after the procedure. The investigator's aim is to compare the efficacy of coccygeal nerve blockade with impar blockade.
Detailed description
Patients with coccygeal pain will be evaluated. Patients with organic pathology such as malignancy and infection on imaging and investigations will be excluded. Seventy-four patients diagnosed with traumatic or idiopathic coccidynia will be included in the study. Patients will be randomised by computer programme. Half of them will undergo ultrasound-guided pericoccygeal nerve blockade and the other half will undergo fluoroscopy-guided impar sympathetic ganglion blockade. Pericoccygeal nerve block is performed with the patients lying in the prone position. The sacral horns are visualised using a linear probe. The coccygeal nerves are captured medial to the sacral cornuas and a combination of local anaesthetic and dexamethasone is injected. Impar sympathetic ganglion blockade It is performed in the operating theatre with the patient in the prone position. The sacrum and coccyx are visualised with a lateral view. A needle is inserted through the sacrococcygeal junction and a combination of local anaesthetic and dexamethasone is injected when an optimal image is obtained with contrast material injection. Patients will be evaluated before, 1 and 3 months after the procedure by filling out the Visual analogue scale and PARIS functional coxidynia questionnaire. The investigator who evaluates the patients and collects the data after the procedure will be blinded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Pericoccygeal block | Active comparator | Device: Pericoccygeal nerve blockPatients undergoing pericoccygeal block |
| Group Impar ganglion block | Active comparator | Procedure: Impar ganglion blockPatients undergoing impar ganglion block |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Coccygeal pain
Key exclusion criteria (3 listed)
- Malignite
- Infection
- Pregnancy
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 |
|---|---|---|
| Pericoccygeal nerve blockThe coccygeal corneas are visualised with a linear probe under ultrasound guidance. The pericoccygeal nerves are located medial to the cornu and a combination of local anaesthetic and dexamethasone is injected. | Device | Group Pericoccygeal block |
| Impar ganglion blockThe sacrum is visualised with fluoroscopy. A needle is inserted through the sacrococcygeal junction. The optimal image is obtained by administering contrast material. A combination of local anaesthetic and dexamethasone is injected. | Procedure or surgery | Group Impar ganglion block |
Primary outcome
Visual analogue scale
Time frame: Before treatment, week 4 and week 12
A Visual Analogue Scale (VAS) is the pain rating scales. Numbers 0-10 represent the severity of the patients' pain. No pain : 0, Most severe pain : 10
1 secondary outcome
PARIS coccidini scale
Time frame: Before treatment, week 4 and week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pericoccygeal nerve block and Impar ganglion block in people with Coccyx Injury and Coccygeal Body Tumor, run by Diskapi Teaching and Research Hospital 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 1 inclusion and 3 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 Mar 2024. 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?
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?
Visual analogue scale (time frame: Before treatment, week 4 and week 12). 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 Mar 2024.