CoccydyniaNCT07564362
Landmark-Guided Dextrose Prolotherapy for Coccydynia: A Retrospective Study
An observational study of Coccydynia, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
Coccydynia is a musculoskeletal pain condition that can lead to chronic pain and functional impairment, significantly affecting quality of life. Although conservative treatment is effective in many cases, the number of patients with refractory symptoms appears to be increasing, highlighting the need for effective and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coccydynia
- What is being tested?
- Dextrose prolotherapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 15 Mar 2026
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of patients aged 18 to 75 years diagnosed with mechanical or idiopathic coccydynia, with symptoms persisting for at least 3 months and refractory to conservative treatment, who underwent landmark-guided (blind) dextrose prolotherapy at the Physical Medicine and Rehabilitation Clinic of Gaziosmanpasa Training and Research Hospital between January 1, 2024, and June 1, 2025.
Who may be able to join
- Age between 18 and 75 years
- Diagnosis of mechanical or idiopathic coccydynia
- Pain persisting for at least 3 months
- Refractory to conservative treatment
Who cannot join
- Pregnancy
- Allergy to the proliferant solution
- Active infection
- Use of anticoagulant medications
- Presence of malignancy
- Local abscess
Show all 9Show fewer
- Documented hemorrhagic diathesis
- Certain types of septic arthritis
- Parafunctional habits
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Gaziosmanpaşa Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, 34255
Istanbul
About this study
Official title: Evaluation of the Effectiveness of Landmark-Guided (Blind) Dextrose Prolotherapy on Pain Severity and Functional Status in Patients With Coccydynia: A Retrospective Study
Coccydynia is a musculoskeletal pain condition that can lead to chronic pain and functional impairment, significantly affecting quality of life. Although conservative treatment is effective in many cases, the number of patients with refractory symptoms appears to be increasing, highlighting the need for effective and accessible treatment options.
Prolotherapy is a regenerative injection therapy that aims to stimulate tissue healing and reduce pain through the modulation of nociceptive signaling, most commonly using dextrose solutions.
This retrospective study aims to evaluate the effectiveness of landmark-guided (blind) dextrose prolotherapy in reducing pain and improving functional status in patients with mechanical or idiopathic coccydynia. The study includes patients who underwent prolotherapy to coccygeal ligaments between January 1, 2024, and June 1, 2025, with a treatment protocol consisting of 3-6 sessions administered at 3-week intervals using a 15% dextrose solution.
Read the detailed description
Coccydynia is a musculoskeletal pain condition characterized by pain localized to the coccygeal region, often leading to chronic pain and functional impairment that negatively affects quality of life. Although conservative treatment is effective in many patients, a growing number of cases remain refractory, highlighting the need for alternative therapeutic approaches.
Prolotherapy is a regenerative injection technique increasingly used in chronic musculoskeletal pain conditions. It aims to stimulate tissue repair and modulate nociceptive signaling through the administration of proliferant solutions, most commonly hypertonic dextrose. By inducing a controlled inflammatory response, prolotherapy is thought to promote fibroblast activity, collagen synthesis, and strengthening of ligamentous structures.
This retrospective cohort study aims to evaluate the effectiveness of landmark-guided (blind) dextrose prolotherapy in reducing pain severity and improving functional status in patients with mechanical or idiopathic coccydynia. The study includes patients who presented to the Physical Medicine and Rehabilitation Clinic of Gaziosmanpasa Training and Research Hospital between January 1, 2024, and June 1, 2025, with coccydynia persisting for at least 3 months and refractory to conservative treatment.
Eligible patients received prolotherapy injections targeting the coccygeal ligaments using anatomical reference points without ultrasound guidance. A 15% dextrose solution was administered in 3 to 6 sessions at 3-week intervals according to a standardized treatment protocol.
Pain severity and functional status were assessed using the Visual Analog Scale (VAS) and the Dallas Pain Questionnaire (DPQ), respectively. Outcome measures were evaluated at baseline (pre-treatment) and at follow-up after completion of the treatment protocol.
A minimum sample size of 30 patients was determined, and a total of 50 patients were included in the study.
- Conditions
- Coccydynia
- Being tested
- Dextrose prolotherapy
- Keywords
- Coccydynia, Dextrose Prolotherapy, Landmark-Guided Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose prolotherapyProcedure or surgery
Landmark-guided (blind) prolotherapy was performed using a 15% dextrose solution under sterile conditions. The procedure was carried out based on anatomical reference points without ultrasound guidance. The coccygeal and sacrococcygeal ligamentous structures were targeted, and injections were administered to 3-4 periosteal insertion points using a 27G needle. A maximum of 0.5 mL was injected per site, with a total volume not exceeding 2-2.5 mL per session. The treatment protocol consisted of 3 to 6 sessions performed at 3-week intervals.
| Study group | Role | What they receive |
|---|---|---|
| Landmark-Guided Dextrose Prolotherapy | This cohort includes patients with mechanical or idiopathic coccydynia who underwent landmark-guided (blind) dextrose prolotherapy using a 15% dextrose solution. Injections were performed to the coccygeal ligamentous structures based on anatomical reference points without ultrasound guidance. Receives: Procedure: Dextrose prolotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Primary Outcome Measure Visual Analog Scale for Pain (VAS): Change in pain intensity assessed using the Visual Analog Scale (VAS).The VAS is a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst imaginable pain).Higher scores indicate greater pain intensity, and a reduction in VAS score represents clinical improvement.
Measured: Baseline and 1 month after completion of treatment
Secondary outcomes (1)
Dallas Pain Questionnaire (DPQ)
The Dallas Pain Questionnaire (DPQ) is a validated instrument that evaluates the impact of chronic pain on functional status across four domains: daily activities, work and leisure activities, anxiety/depression, and social interest. Scores range from 0 to 100, with higher scores indicating greater functional limitation and a higher degree of pain-related impairment, whereas lower scores reflect better functional capacity and lower levels of impairment.
Measured: Baseline and 1 month after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start15 Jan 2026
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
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 CoccydyniaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yunus Emrah Koşut, Gaziosmanpasa Research and Education Hospital
- Investigators
- Merve Dikici Yagli, Study chair, Gaziosmanpasa Educational and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564362
- Sponsor's protocol ID
- 01
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2026
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Assiri K, Alqarni A, Almubarak H, Mohammed Kaleem S, Alassiri S, Baig FAH, Muhammed A, Kota MZ, Dawasaz AA, Alqahtani AM, Assiri HA, Arem SA, Abubaker Abbas Ali S, Luqman Mannakandath M. Efficacy of Prolotherapy for Temporomandibular Joint Dysfunction: An Interventional Clinical Study. Med Sci Monit. 2025 May 14;31:e946650. doi: 10.12659/MSM.946650.
PubMed 40364487Mociu SI, Nedelcu AD, Lupu AA, Uzun AB, Iliescu DM, Ionescu EV, Iliescu MG. Prolotherapy as a Regenerative Treatment in the Management of Chronic Low Back Pain: A Systematic Review. Medicina (Kaunas). 2025 Sep 2;61(9):1588. doi: 10.3390/medicina61091588.
PubMed 41010979Benditz A, Thoma R. Coccygodynia-Diagnosis and Treatment. Dtsch Arztebl Int. 2025 Nov 14;122(23):638-644. doi: 10.3238/arztebl.m2025.0154. Epub 2025 Nov 14.
PubMed 40991348Khan SA, Kumar A, Varshney MK, Trikha V, Yadav CS. Dextrose prolotherapy for recalcitrant coccygodynia. J Orthop Surg (Hong Kong). 2008 Apr;16(1):27-9. doi: 10.1177/230949900801600107.
PubMed 18453654
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Landmark-Guided (Blind) Dextrose Prolotherapy on Pain Severity and Functional Status in Patients With Coccydynia: A Retrospective Study
- ClinicalTrials.gov ID
- NCT07564362
- Acronym / sponsor ID
- 01
- Conditions
- Coccydynia
- Keywords
- Coccydynia, Dextrose Prolotherapy, Landmark-Guided Injection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 4 May 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.
Coccydynia is a musculoskeletal pain condition that can lead to chronic pain and functional impairment, significantly affecting quality of life. Although conservative treatment is effective in many cases, the number of patients with refractory symptoms appears to be increasing, highlighting the need for effective and accessible treatment options.
Prolotherapy is a regenerative injection therapy that aims to stimulate tissue healing and reduce pain through the modulation of nociceptive signaling, most commonly using dextrose solutions.
This retrospective study aims to evaluate the effectiveness of landmark-guided (blind) dextrose prolotherapy in reducing pain and improving functional status in patients with mechanical or idiopathic coccydynia. The study includes patients who underwent prolotherapy to coccygeal ligaments between January 1, 2024, and June 1, 2025, with a treatment protocol consisting of 3-6 sessions administered at 3-week intervals using a 15% dextrose solution.
Detailed description
Coccydynia is a musculoskeletal pain condition characterized by pain localized to the coccygeal region, often leading to chronic pain and functional impairment that negatively affects quality of life. Although conservative treatment is effective in many patients, a growing number of cases remain refractory, highlighting the need for alternative therapeutic approaches.
Prolotherapy is a regenerative injection technique increasingly used in chronic musculoskeletal pain conditions. It aims to stimulate tissue repair and modulate nociceptive signaling through the administration of proliferant solutions, most commonly hypertonic dextrose. By inducing a controlled inflammatory response, prolotherapy is thought to promote fibroblast activity, collagen synthesis, and strengthening of ligamentous structures.
This retrospective cohort study aims to evaluate the effectiveness of landmark-guided (blind) dextrose prolotherapy in reducing pain severity and improving functional status in patients with mechanical or idiopathic coccydynia. The study includes patients who presented to the Physical Medicine and Rehabilitation Clinic of Gaziosmanpasa Training and Research Hospital between January 1, 2024, and June 1, 2025, with coccydynia persisting for at least 3 months and refractory to conservative treatment.
Eligible patients received prolotherapy injections targeting the coccygeal ligaments using anatomical reference points without ultrasound guidance. A 15% dextrose solution was administered in 3 to 6 sessions at 3-week intervals according to a standardized treatment protocol.
Pain severity and functional status were assessed using the Visual Analog Scale (VAS) and the Dallas Pain Questionnaire (DPQ), respectively. Outcome measures were evaluated at baseline (pre-treatment) and at follow-up after completion of the treatment protocol.
A minimum sample size of 30 patients was determined, and a total of 50 patients were included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Landmark-Guided Dextrose Prolotherapy | – | Procedure: Dextrose prolotherapyThis cohort includes patients with mechanical or idiopathic coccydynia who underwent landmark-guided (blind) dextrose prolotherapy using a 15% dextrose solution. Injections were performed to the coccygeal ligamentous structures based on anatomical reference points without ultrasound guidance. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of patients aged 18 to 75 years diagnosed with mechanical or idiopathic coccydynia, with symptoms persisting for at least 3 months and refractory to conservative treatment, who underwent landmark-guided (blind) dextrose prolotherapy at the Physical Medicine and Rehabilitation Clinic of Gaziosmanpasa Training and Research Hospital between January 1, 2024, and June 1, 2025.
Key inclusion criteria (4 listed)
- Age between 18 and 75 years
- Diagnosis of mechanical or idiopathic coccydynia
- Pain persisting for at least 3 months
- Refractory to conservative treatment
Key exclusion criteria (9 listed)
- Pregnancy
- Allergy to the proliferant solution
- Active infection
- Use of anticoagulant medications
- Presence of malignancy
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 prolotherapyLandmark-guided (blind) prolotherapy was performed using a 15% dextrose solution under sterile conditions. The procedure was carried out based on anatomical reference points without ultrasound guidance. The coccygeal and sacrococcygeal ligamentous structures were targeted, and injections were administered to 3-4 periosteal insertion points using a 27G needle. A maximum of 0.5 mL was injected per site, with a total volume not exceeding 2-2.5 mL per session. The treatment protocol consisted of 3 to 6 sessions performed at 3-week intervals. | Procedure or surgery | Landmark-Guided Dextrose Prolotherapy |
Primary outcome
Visual Analog Scale (VAS)
Time frame: Baseline and 1 month after completion of treatment
Primary Outcome Measure Visual Analog Scale for Pain (VAS): Change in pain intensity assessed using the Visual Analog Scale (VAS).The VAS is a 10-cm horizontal scale ranging from 0 (no pain) to 10 (worst imaginable pain).Higher scores indicate greater pain intensity, and a reduction in VAS score represents clinical improvement.
1 secondary outcome
Dallas Pain Questionnaire (DPQ)
Time frame: Baseline and 1 month after completion of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 40364487Assiri K, Alqarni A, Almubarak H, Mohammed Kaleem S, Alassiri S, Baig FAH, Muhammed A, Kota MZ, Dawasaz AA, Alqahtani AM, Assiri HA, Arem SA, Abubaker Abbas Ali S, Luqman Mannakandath M. Efficacy of Prolotherapy for Temporomandibular Joint Dysfunction: An Interventional Clinical Study. Med Sci Monit. 2025 May 14;31:e946650. doi: 10.12659/MSM.946650.
- Background: PubMed 41010979Mociu SI, Nedelcu AD, Lupu AA, Uzun AB, Iliescu DM, Ionescu EV, Iliescu MG. Prolotherapy as a Regenerative Treatment in the Management of Chronic Low Back Pain: A Systematic Review. Medicina (Kaunas). 2025 Sep 2;61(9):1588. doi: 10.3390/medicina61091588.
- Background: PubMed 40991348Benditz A, Thoma R. Coccygodynia-Diagnosis and Treatment. Dtsch Arztebl Int. 2025 Nov 14;122(23):638-644. doi: 10.3238/arztebl.m2025.0154. Epub 2025 Nov 14.
- Background: PubMed 18453654Khan SA, Kumar A, Varshney MK, Trikha V, Yadav CS. Dextrose prolotherapy for recalcitrant coccygodynia. J Orthop Surg (Hong Kong). 2008 Apr;16(1):27-9. doi: 10.1177/230949900801600107.
- 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.
Merve Dikici Yagli study chair
Gaziosmanpasa Educational and Training Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coccydynia, run by Gaziosmanpasa Research and Education 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 9 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: finished, as of the sponsor's last update on 4 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Analog Scale (VAS) (time frame: Baseline and 1 month after completion of treatment). 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 NCT07564362, 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 4 May 2026.