Ultrasound-Guided Dextrose Prolotherapy for Coccydynia: A Prospective Study
ConditionCoccydynia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGaziosmanpasa Research and Education Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 75 years
Pain persisting for ≥3 months and refractory to conservative treatment
Coccydynia of mechanical or idiopathic origin
Disqualifiers
Age <18 years or >75 years
Pregnancy
Allergy to the proliferant solution
Active infection
Trial design
Design model
Single group
Treatments tested in this trial
Dextrose prolotherapy
Procedure/SurgeryAll 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Dextrose ProlotherapyExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline and 1 month after completion of treatmentSecondary 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.
Time frame
Baseline and 1 month after completion of treatmentSponsors and contacts
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Source ClinicalTrials.gov