CoccydyniaNCT07552298
The Effectiveness of Dextrose Prolotherapy in Patients With Coccydynia
A study testing Dextrose prolotherapy (DPT) and Physiological Saline Injection in people with Coccydynia, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
In this prospective, randomized, controlled, double-blinded study, we aimed to evaluate the effects of Dextrose Prolotherapy injections in patients with coccydynia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coccydynia
- What is being tested?
- Dextrose prolotherapy (DPT) and Physiological Saline Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jun 2025to 15 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with coccydynia lasting longer than 6 months,
- Those unresponsive to at least 6 months of conventional conservative treatment methods,
- Those with coccygeal tenderness on palpation,
- Patients aged between 18 and 65 years.
Who cannot join
- Patients with a history of trauma within the last 3 months or postpartum coccydynia,
- Those with lesions or infections at the injection site,
- Those with dislocation or organic bone pathology of the coccyx observed on X-ray imaging,
- Those with fecal or urinary incontinence,
- Patients with poorly controlled diabetes mellitus,
- Those with a history of malignancy,
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- Patients with a bleeding tendency (acquired or hereditary) [INR > 2 in patients using warfarin],
- Those with a history of myelomeningocele,
- Those diagnosed with spina bifida,
- Patients with rheumatologic disease,
- Those who have undergone coccyx injection or ganglion block within the last 3 months,
- Patients with severe comorbidities.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Serhat Yavuz contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
Istanbul
Ekin I Sen, Assoc.Prof., +902124142000 ext. 12856, ekinozgorgu@gmail.com
Serhat Yavuz, MD
About this study
In this prospective, randomized, controlled, double-blinded study, we aimed to evaluate the effects of Dextrose Prolotherapy injections in patients with coccydynia.
Read the detailed description
Patients will be informed verbally and in writing about the purpose, duration, and procedure of the study, and their consent will be obtained by signing the "Informed Consent Form." The study aims to evaluate the effectiveness of dextrose prolotherapy applied in coccydynia. The duration of the study is determined to be approximately one year, and it is planned to include 40 patients who will be randomized by a computer program according to the order of application. Patients who meet the inclusion and exclusion criteria will be randomized into two groups. In the first group, in addition to protection recommendations, three sessions of dextrose prolotherapy will be administered at three-week intervals. In the second group, in addition to protection recommendations, three sessions of a superficial saline-lidocaine combination will be administered at three-week intervals. After the application, patients will be questioned for side effects and complications. The effectiveness of dextrose prolotherapy will be evaluated in comparison with the superficial saline-lidocaine combination group. Patients' medical histories will be taken, and demographic characteristics such as age, gender, height, weight, marital status, education level, and occupation will be recorded, along with medical histories such as comorbidities and previous treatments. In the physical examination, lumbar and sacroiliac tests will be applied, the sacrococcygeal region will be palpated, and the average and maximum levels of pain during activity, at rest, and at night will be assessed using the Visual Analog Scale (0-10 points). Functional status will be evaluated using the Paris Functional Coccydynia Questionnaire. Assessments will be conducted before treatment and at the 1st, 3rd, and 6th months after treatment.
- Conditions
- Coccydynia
- Being tested
- Dextrose prolotherapy (DPT), Physiological Saline Injection
- Keywords
- prolotherapy, coccydynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose prolotherapy (DPT)Procedure or surgery
Coccyx injection: Using a sterile 27-gauge syringe (dental needle), a total of 10 cc of solution (5 cc of 30% dextrose + 4 cc of physiological saline + 1 cc of 1% lidocaine solution) will be injected perpendicularly to the surface at the previously marked attachment points of the sacrococcygeal-sacro-tuberous ligaments to the sacrum and along the entire coccyx.
Physiological Saline InjectionProcedure or surgery
Saline + lidocaine group injection protocol: Using a sterile 30-gauge syringe (insulin needle), a total of 10 cc of solution (5 cc of physiological saline + 5 cc of 1% lidocaine solution) will be injected into the previously marked tendon attachment points on the bone.
| Study group | Role | What they receive |
|---|---|---|
| Dextrose Prolotherapy | Active comparator | Coccyx injection: Using a sterile 27-gauge syringe (dental needle), a total of 10 cc of solution (5 cc of 30% dextrose + 4 cc of physiological saline + 1 cc of 1% lidocaine solution) will be injected perpendicularly to the surface at the previously marked attachment points of the sacrococcygeal-sacro-tuberous ligaments to the sacrum and along the entire coccyx. Receives: Procedure: Dextrose prolotherapy (DPT) |
| Physiological Saline | Active comparator | Saline + lidocaine group injection protocol: Using a sterile 30-gauge syringe (insulin needle), a total of 10 cc of solution (5 cc of physiological saline + 5 cc of 1% lidocaine solution) will be injected into the previously marked tendon attachment points on the bone. Receives: Procedure: Physiological Saline Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale
Pain intensity during sitting and activity
Measured: Before treatment, and at the 1st, 3rd, and 6th months following treatment
Secondary outcomes (2)
Paris Functional Coccydynia Questionnaire
Functional status assessment
Measured: Before treatment and at the 1st, 3rd, and 6th months after treatment
Visual Analog Scale-Global Assesment
Daily living activities and patient global assessment
Measured: before treatment, and at the 1st, 3rd, and 6th months following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2026
- Study start15 Jun 2025
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoccydyniaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekin Ilke Sen, Istanbul University
- Investigators
- Ekin I Sen, Assoc.Prof., Principal investigator, Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07552298
- Sponsor's protocol ID
- IstanbulU-2022-77979112
- Status last verified
- Nov 2025
- First submitted
- 10 Apr 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Dextrose Prolotherapy in Patients With Coccydynia
- ClinicalTrials.gov ID
- NCT07552298
- Acronym / sponsor ID
- IstanbulU-2022-77979112
- Conditions
- Coccydynia
- Keywords
- prolotherapy, coccydynia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 27 Apr 2026 (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.
In this prospective, randomized, controlled, double-blinded study, we aimed to evaluate the effects of Dextrose Prolotherapy injections in patients with coccydynia.
Detailed description
Patients will be informed verbally and in writing about the purpose, duration, and procedure of the study, and their consent will be obtained by signing the "Informed Consent Form." The study aims to evaluate the effectiveness of dextrose prolotherapy applied in coccydynia. The duration of the study is determined to be approximately one year, and it is planned to include 40 patients who will be randomized by a computer program according to the order of application. Patients who meet the inclusion and exclusion criteria will be randomized into two groups. In the first group, in addition to protection recommendations, three sessions of dextrose prolotherapy will be administered at three-week intervals. In the second group, in addition to protection recommendations, three sessions of a superficial saline-lidocaine combination will be administered at three-week intervals. After the application, patients will be questioned for side effects and complications. The effectiveness of dextrose prolotherapy will be evaluated in comparison with the superficial saline-lidocaine combination group. Patients' medical histories will be taken, and demographic characteristics such as age, gender, height, weight, marital status, education level, and occupation will be recorded, along with medical histories such as comorbidities and previous treatments. In the physical examination, lumbar and sacroiliac tests will be applied, the sacrococcygeal region will be palpated, and the average and maximum levels of pain during activity, at rest, and at night will be assessed using the Visual Analog Scale (0-10 points). Functional status will be evaluated using the Paris Functional Coccydynia Questionnaire. Assessments will be conducted before treatment and at the 1st, 3rd, and 6th months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dextrose Prolotherapy | Active comparator | Procedure: Dextrose prolotherapy (DPT)Coccyx injection: Using a sterile 27-gauge syringe (dental needle), a total of 10 cc of solution (5 cc of 30% dextrose + 4 cc of physiological saline + 1 cc of 1% lidocaine solution) will be injected perpendicularly to the surface at the previously marked attachment points of the sacrococcygeal-sacro-tuberous ligaments to the sacrum and along the entire coccyx. |
| Physiological Saline | Active comparator | Procedure: Physiological Saline InjectionSaline + lidocaine group injection protocol: Using a sterile 30-gauge syringe (insulin needle), a total of 10 cc of solution (5 cc of physiological saline + 5 cc of 1% lidocaine solution) will be injected into the previously marked tendon attachment points on the bone. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with coccydynia lasting longer than 6 months,
- Those unresponsive to at least 6 months of conventional conservative treatment methods,
- Those with coccygeal tenderness on palpation,
- Patients aged between 18 and 65 years.
Key exclusion criteria (12 listed)
- Patients with a history of trauma within the last 3 months or postpartum coccydynia,
- Those with lesions or infections at the injection site,
- Those with dislocation or organic bone pathology of the coccyx observed on X-ray imaging,
- Those with fecal or urinary incontinence,
- Patients with poorly controlled diabetes mellitus,
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 |
|---|---|---|
| Dextrose prolotherapy (DPT)Coccyx injection: Using a sterile 27-gauge syringe (dental needle), a total of 10 cc of solution (5 cc of 30% dextrose + 4 cc of physiological saline + 1 cc of 1% lidocaine solution) will be injected perpendicularly to the surface at the previously marked attachment points of the sacrococcygeal-sacro-tuberous ligaments to the sacrum and along the entire coccyx. | Procedure or surgery | Dextrose Prolotherapy |
| Physiological Saline InjectionSaline + lidocaine group injection protocol: Using a sterile 30-gauge syringe (insulin needle), a total of 10 cc of solution (5 cc of physiological saline + 5 cc of 1% lidocaine solution) will be injected into the previously marked tendon attachment points on the bone. | Procedure or surgery | Physiological Saline |
Primary outcome
Visual Analog Scale
Time frame: Before treatment, and at the 1st, 3rd, and 6th months following treatment
Pain intensity during sitting and activity
2 secondary outcomes
Paris Functional Coccydynia Questionnaire
Time frame: Before treatment and at the 1st, 3rd, and 6th months after treatment
Visual Analog Scale-Global Assesment
Time frame: before treatment, and at the 1st, 3rd, and 6th months following treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
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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.
Serhat Yavuz contact
Ekin I Sen, Assoc.Prof. principal investigator
Istanbul University Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextrose prolotherapy (DPT) and Physiological Saline Injection in people with Coccydynia, run by Istanbul 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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ekin I Sen, Assoc.Prof. (+902124142000 ext. 12856, ekinozgorgu@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Before treatment, and at the 1st, 3rd, and 6th months following 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 27 Apr 2026.