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CoccydyniaNCT07564167

Ultrasound-Guided Dextrose Prolotherapy for Coccydynia: A Prospective Study

A study testing Dextrose prolotherapy in people with Coccydynia, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Coccydynia is a musculoskeletal condition characterized by pain in the coccygeal region, particularly exacerbated by sitting, and is associated with impaired quality of life and functional limitation. 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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Jan 2026to 15 Jun 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 18 and 75 years
  • Pain persisting for ≥3 months and refractory to conservative treatment
  • Coccydynia of mechanical or idiopathic origin

Who cannot join

  • Age <18 years or >75 years
  • Pregnancy
  • Allergy to the proliferant solution
  • Active infection
  • Use of anticoagulant medications
  • Presence of malignancy
Show all 10Show fewer
  • Local abscess
  • Hemorrhagic diathesis
  • Certain types of septic arthritis
  • Parafunctional habits

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Merve Dikici Yagli, M.D contact

+905387192098

mervedikici1992@gmail.com

Yunus Emrah Kosut, M.D contact

+905355540389

kosutyunus@gmail.com

Turkey (Türkiye)1 site, 1 recruiting
  • Gaziosmanpasa Research and Education Hospital

    Istanbul

    Merve Dikici Yaglı, M.D, +905387192098, mervedikici1992@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effectiveness of Dextrose Prolotherapy on Pain Severity and Functional Status in Patients With Coccydynia: A Prospective Study

Coccydynia is a musculoskeletal condition characterized by pain in the coccygeal region, particularly exacerbated by sitting, and is associated with impaired quality of life and functional limitation. Although various conservative and interventional treatment options are available, there remains a need for effective and safe alternative therapies, especially in treatment-resistant cases.

Prolotherapy is a regenerative treatment modality that aims to reduce pain and improve function by stimulating tissue repair, particularly in ligamentous structures. While there is increasing evidence supporting its effectiveness in mechanical musculoskeletal pain conditions, the literature regarding its use in coccydynia is limited.

Read more

The aim of this study is to evaluate the effect of dextrose prolotherapy on pain severity and functional status in patients diagnosed with coccydynia. This study is designed as a prospective, single-arm, open-label interventional study. Patients will receive 15% dextrose prolotherapy according to a standardized protocol. Pain severity will be assessed using the Visual Analog Scale (VAS), and functional status will be evaluated using the Dallas Pain Questionnaire before treatment and at 1 month after completion of the treatment.

This study aims to provide more comprehensive data on the effectiveness and safety of prolotherapy in coccydynia and to contribute to the currently limited evidence in the literature.

Read the detailed description

Coccydynia is a musculoskeletal disorder characterized by localized pain in the coccygeal region, typically exacerbated by sitting and postural changes, and associated with impaired quality of life and functional limitation. Although various conservative and interventional treatment modalities have been described, a subset of patients remains symptomatic despite standard therapies. Considering the potential role of ligamentous dysfunction, repetitive microtrauma, and coccygeal instability in the pathophysiology of coccydynia, regenerative treatment approaches such as prolotherapy may provide clinical benefit.

Prolotherapy is a regenerative injection therapy that involves the administration of an irritant solution, most commonly hypertonic dextrose, to stimulate the body's natural healing response. The proposed mechanism includes induction of a mild, controlled inflammatory response, leading to increased fibroblast proliferation, collagen synthesis, and subsequent strengthening of ligamentous and periarticular structures. In conditions associated with ligamentous laxity or enthesopathy, prolotherapy is thought to enhance tissue repair and restore biomechanical stability. Increasing evidence suggests that prolotherapy may reduce pain and improve function in various chronic musculoskeletal conditions, particularly those with a mechanical or ligamentous component. However, evidence regarding its effectiveness in coccydynia remains limited.

This study is designed as a prospective, single-arm, open-label interventional study to evaluate the effectiveness and safety of dextrose prolotherapy in patients with chronic coccydynia. Adult patients (≥18 years) with mechanical or idiopathic coccydynia persisting for at least 3 months and unresponsive to conservative treatment will be included. Patients with pregnancy, malignancy, active infection, bleeding diathesis, uncontrolled hypertension or diabetes mellitus, or contraindications to prolotherapy will be excluded.

All participants will receive prolotherapy using a 15% dextrose solution prepared under sterile conditions. Injections will be performed under ultrasound (USG) guidance to ensure precise anatomical localization and to enhance procedural safety. During the procedure, the sacral hiatus, sacrococcygeal ligament, and coccygeal bony structures will be visualized, and bone landmarks will be used as references. The fibrous ligamentous attachments in the coccygeal and sacrococcygeal region will be targeted, and injections will be administered to 3-4 periosteal insertion points using a 27G needle, with a maximum of 0.5 mL per site and a total volume not exceeding 2-2.5 mL per session. The procedure will be repeated at 3-week intervals, with a total of 3 to 6 sessions depending on clinical response.

The primary outcome measure will be the change in pain severity assessed by the Visual Analog Scale (VAS). The secondary outcome measure will be the change in functional status evaluated using the Dallas Pain Questionnaire. Outcome assessments will be performed at baseline (pre-treatment) and at 1 month after completion of the treatment protocol.

Sample size was calculated based on a power analysis (α=0.05, power=0.80), which indicated that a minimum of 25 patients would be required. Considering a potential 15% dropout rate, a total of 30 patients will be enrolled.

Safety will be assessed by monitoring and recording any adverse events throughout the study period. All participants will be followed prospectively, and changes in clinical parameters will be analyzed to determine the effectiveness of the intervention.

Conditions
Coccydynia
Being tested
Dextrose prolotherapy
Keywords
Coccydynia, Dextrose Prolotherapy, Ultrasound-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

    All participants will receive prolotherapy using a 15% dextrose solution prepared under sterile conditions. Injections will be performed under ultrasound (USG) guidance to ensure precise anatomical localization and to enhance procedural safety. During the procedure, the sacral hiatus, sacrococcygeal ligament, and coccygeal bony structures will be visualized, and bone landmarks will be used as references. The fibrous ligamentous attachments in the coccygeal and sacrococcygeal region will be targeted, and injections will be administered to 3-4 periosteal insertion points using a 27G needle, with a maximum of 0.5 mL per site and a total volume not exceeding 2-2.5 mL per session. The procedure will be repeated at 3-week intervals, with a total of 3 to 6 sessions depending on clinical response.

Study groups in NCT07564167
Study groupRoleWhat they receive
Dextrose ProlotherapyExperimentalParticipants will receive ultrasound-guided dextrose prolotherapy according to a standardized treatment protocol.
Receives: Procedure: Dextrose prolotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale

    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)
  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.

  1. First posted4 May 2026
  2. Study start15 Jan 2026
  3. Primary completion15 Jun 2026 (estimated)
  4. Study completion15 Jun 2026 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Model description
This study follows a single-group assignment model in which all participants receive ultrasound-guided dextrose prolotherapy. The intervention is applied at predefined intervals, and treatment effects are evaluated by comparing baseline and post-treatment outcomes.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07564167
Sponsor's protocol ID
14
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: Individual participant data will not be shared due to institutional data protection policies and the absence of participant consent for data sharing beyond the scope of the current study.

Publications

  • Mociu 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 41010979
  • Benditz 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 40991348
  • Khan 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

Questions about this trial

What is this clinical trial studying?

A study testing Dextrose prolotherapy in people with 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 3 inclusion and 10 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 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?

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 Merve Dikici Yagli, M.D (+905387192098, mervedikici1992@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: 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 NCT07564167, which also lists 3 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.

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