NCT07564362

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 15, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 27, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 4, 2026

Completed
Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

April 27, 2026

Last Update Submit

April 27, 2026

Conditions

Keywords

CoccydyniaDextrose ProlotherapyLandmark-Guided Injection

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline and 1 month after completion of treatment

Secondary Outcomes (1)

  • Dallas Pain Questionnaire (DPQ)

    Baseline and 1 month after completion of treatment

Study Arms (1)

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.

Procedure: Dextrose prolotherapy

Interventions

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.

Landmark-Guided Dextrose Prolotherapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Age between 18 and 75 years
  • Diagnosis of mechanical or idiopathic coccydynia
  • Pain persisting for at least 3 months
  • Refractory to conservative treatment

You may not qualify if:

  • Pregnancy
  • Allergy to the proliferant solution
  • Active infection
  • Use of anticoagulant medications
  • Presence of malignancy
  • Local abscess
  • Documented hemorrhagic diathesis
  • Certain types of septic arthritis
  • Parafunctional habits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences University Gaziosmanpaşa Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, 34255

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • 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.

    PMID: 40364487BACKGROUND
  • 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.

    PMID: 41010979BACKGROUND
  • Benditz A, Thoma R. Coccygodynia-Diagnosis and Treatment. Dtsch Arztebl Int. 2025 Nov 14;122(23):638-644. doi: 10.3238/arztebl.m2025.0154.

    PMID: 40991348BACKGROUND
  • 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.

    PMID: 18453654BACKGROUND

Study Officials

  • Merve Dikici Yagli

    Gaziosmanpasa Educational and Training Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 4, 2026

Study Start

January 15, 2026

Primary Completion

March 15, 2026

Study Completion

March 15, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations