Ultrasound-Guided Dextrose Prolotherapy for Coccydynia: A Prospective Study

NCT07564167 | Recruiting

• 1 other identifier: 14
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Coccydynia

Keywords

Coccydynia; Dextrose Prolotherapy; Ultrasound-Guided Injection

Outcome Measures

Primary Outcomes (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.

  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)

Dextrose Prolotherapy

EXPERIMENTAL

Participants will receive ultrasound-guided dextrose prolotherapy according to a standardized treatment protocol.

Procedure: Dextrose prolotherapy

Interventions

Dextrose prolotherapy PROCEDURE

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.

Dextrose Prolotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

Gaziosmanpasa Research and Education Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

• 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: 41010979 BACKGROUND

• 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: 40991348 BACKGROUND

• 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: 18453654 BACKGROUND

Study Officials

• Merve Dikici Yagli, M.D

  Gaziosmanpasa Research and Education Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merve Dikici Yagli, M.D

CONTACT

+905387192098; mervedikici1992@gmail.com

Yunus Emrah Kosut, M.D

CONTACT

+905355540389; kosutyunus@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): June 15, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)