Coccyx DisorderPhase 2/3NCT06315244
Perforating Cutaneous Nerve Injection Efficacy in Chronic Coccydynia: A Randomized, Double-Blind Study
A Phase 2/3 study testing US Guided Perineural Injection and Neuroprolotherapy in people with Coccyx Disorder and Coccyx Injury, run by Sisli Hamidiye Etfal Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Interventions targeting the perforating cutaneous nerve are relatively new to the literature, with a safe side-effect profile but lacking high-quality studies. Their effectiveness remains at the level of case presentations. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Coccyx Disorder, Coccyx Injury
- What is being tested?
- US Guided Perineural Injection and Neuroprolotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 1 Oct 2024
- Phase
- Phase 2/3
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 50 years.
- Chronic coccyx pain (≥3 months).
- Pain Visual Analogue Scale (VAS) score ≥4.
- Pain not alleviated by first-line treatment (physical therapy/oral analgesic therapy + sitting cushion).
Who cannot join
- Injection to the area in the last 3 months.
- Concurrent mechanical or inflammatory low back pain.
- Coccyx pain that started during pregnancy or postpartum.
- History of myelomeningocele or spina bifida.
- History of sacrococcygeal luxation or subluxation (confirmed by radiography).
- History of coccyx fracture.
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- Concurrent neurological deficit.
- Skin disease affecting the injection area.
- History of malignancy.
- Pregnancy or breastfeeding.
- Severe coagulopathy.
- Infection at the injection site.
- Neurological or psychiatric diseases, including ongoing depression (Beck Depression Inventory Score >14).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul, 34371
Enes Efe Is, MD, +902123735000, enefeis@gmail.com
Enes Efe Is, MD
About this study
Official title: Effectiveness of Perforating Cutaneous Nerve Injection in Patients With Chronic Coccydynia: A Prospective, Randomized, Placebo-Controlled, Double-Blind Study
Interventions targeting the perforating cutaneous nerve are relatively new to the literature, with a safe side-effect profile but lacking high-quality studies. Their effectiveness remains at the level of case presentations. According to the hypothesis expressed in these publications, coccydynia might be an overlooked cause due to the compression of the perforating cutaneous nerve where it pierces the sacrotuberous ligament and becomes superficial. Ultimately, it is hypothesized that injection of dextrose into this ligament and the sensory area of this nerve will resolve these symptoms due to nerve entrapment, similar to other entrapment neuropathies treated with 5% dextrose, like carpal tunnel syndrome.
- Conditions
- Coccyx Disorder, Coccyx Injury
- Being tested
- US Guided Perineural Injection and Neuroprolotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
US Guided Perineural Injection and NeuroprolotherapyProcedure or surgery
Participants will receive an ultrasound-guided injection of a solution into the sacrotuberous ligament and the sensory innervation area of the perforating cutaneous nerve.
| Study group | Role | What they receive |
|---|---|---|
| %5 Dextrose Injection Group | Experimental | Participants in this arm will receive an ultrasound-guided injection of 5% dextrose solution into the sacrotuberous ligament and the sensory innervation area of the perforating cutaneous nerve. The intervention aims to alleviate symptoms of chronic coccydynia by reducing nerve entrapment. Participants will continue their existing physical therapy/medical treatment regimen throughout the study. Receives: Procedure: US Guided Perineural Injection and Neuroprolotherapy |
| Placebo Injection Group | Placebo comparator | Participants in this arm will receive an ultrasound-guided injection of a placebo solution (saline) into the same anatomical region as the experimental group. This arm serves as a control to evaluate the efficacy of the dextrose injection in treating chronic coccydynia symptoms. Participants will continue their existing physical therapy/medical treatment regimen throughout the study. Receives: Procedure: US Guided Perineural Injection and Neuroprolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Perforating Cutaneous Nerve Injection
To evaluate the effectiveness of perforating cutaneous nerve injection in reducing pain in patients with chronic coccydynia. Pain levels will be assessed using the Visual Analogue Scale (VAS) during sitting, movement and rest.
Measured: Baseline, 2 weeks, 1 month, and 3 months post-treatment
Secondary outcomes (2)
Change in Pressure Pain Threshold
Assessment of the pressure pain threshold using an algometer.
Measured: Baseline, 2 weeks, 1 month, and 3 months post-treatment
Change in Quality of Life
Assessment of quality of life using the EuroQoL questionnaire.
Measured: Baseline, 2 weeks, 1 month, and 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coccyx DisorderStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enes Efe Is, Sisli Hamidiye Etfal Training and Research Hospital
- Investigators
- Julide Oncu Alptekin, Professor, Study chair, Sisli Hamidiye Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315244
- Sponsor's protocol ID
- 2558
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 18 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Perforating Cutaneous Nerve Injection in Patients With Chronic Coccydynia: A Prospective, Randomized, Placebo-Controlled, Double-Blind Study
- ClinicalTrials.gov ID
- NCT06315244
- Acronym / sponsor ID
- 2558
- Conditions
- Coccyx Disorder, Coccyx Injury
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sisli Hamidiye Etfal Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 18 Mar 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.
Interventions targeting the perforating cutaneous nerve are relatively new to the literature, with a safe side-effect profile but lacking high-quality studies. Their effectiveness remains at the level of case presentations. According to the hypothesis expressed in these publications, coccydynia might be an overlooked cause due to the compression of the perforating cutaneous nerve where it pierces the sacrotuberous ligament and becomes superficial. Ultimately, it is hypothesized that injection of dextrose into this ligament and the sensory area of this nerve will resolve these symptoms due to nerve entrapment, similar to other entrapment neuropathies treated with 5% dextrose, like carpal tunnel syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| %5 Dextrose Injection Group | Experimental | Procedure: US Guided Perineural Injection and NeuroprolotherapyParticipants in this arm will receive an ultrasound-guided injection of 5% dextrose solution into the sacrotuberous ligament and the sensory innervation area of the perforating cutaneous nerve. The intervention aims to alleviate symptoms of chronic coccydynia by reducing nerve entrapment. Participants will continue their existing physical therapy/medical treatment regimen throughout the study. |
| Placebo Injection Group | Placebo comparator | Procedure: US Guided Perineural Injection and NeuroprolotherapyParticipants in this arm will receive an ultrasound-guided injection of a placebo solution (saline) into the same anatomical region as the experimental group. This arm serves as a control to evaluate the efficacy of the dextrose injection in treating chronic coccydynia symptoms. Participants will continue their existing physical therapy/medical treatment regimen throughout the study. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 50 years.
- Chronic coccyx pain (≥3 months).
- Pain Visual Analogue Scale (VAS) score ≥4.
- Pain not alleviated by first-line treatment (physical therapy/oral analgesic therapy + sitting cushion).
Key exclusion criteria (13 listed)
- Injection to the area in the last 3 months.
- Concurrent mechanical or inflammatory low back pain.
- Coccyx pain that started during pregnancy or postpartum.
- History of myelomeningocele or spina bifida.
- History of sacrococcygeal luxation or subluxation (confirmed by radiography).
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 |
|---|---|---|
| US Guided Perineural Injection and NeuroprolotherapyParticipants will receive an ultrasound-guided injection of a solution into the sacrotuberous ligament and the sensory innervation area of the perforating cutaneous nerve. | Procedure or surgery | %5 Dextrose Injection Group, Placebo Injection Group |
Primary outcome
Effectiveness of Perforating Cutaneous Nerve Injection
Time frame: Baseline, 2 weeks, 1 month, and 3 months post-treatment
To evaluate the effectiveness of perforating cutaneous nerve injection in reducing pain in patients with chronic coccydynia. Pain levels will be assessed using the Visual Analogue Scale (VAS) during sitting, movement and rest.
2 secondary outcomes
Change in Pressure Pain Threshold
Time frame: Baseline, 2 weeks, 1 month, and 3 months post-treatment
Change in Quality of Life
Time frame: Baseline, 2 weeks, 1 month, and 3 months post-treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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.
Julide Oncu Alptekin, Professor study chair
Sisli Hamidiye Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing US Guided Perineural Injection and Neuroprolotherapy in people with Coccyx Disorder and Coccyx Injury, run by Sisli Hamidiye Etfal Training 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 4 inclusion and 13 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 18 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Enes Efe Is, MD (+903735000, enefeis@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of Perforating Cutaneous Nerve Injection (time frame: Baseline, 2 weeks, 1 month, and 3 months post-treatment). 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 18 Mar 2024.