- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07564362
Landmark-Guided Dextrose Prolotherapy for Coccydynia: A Retrospective Study
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.
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Istanbul, Turecko (Türkiye)
- Health Sciences University Gaziosmanpaşa Physical Medicine and Rehabilitation Training and Research Hospital, Istanbul, 34255
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Age between 18 and 75 years
- Diagnosis of mechanical or idiopathic coccydynia
- Pain persisting for at least 3 months
- Refractory to conservative treatment
Exclusion Criteria:
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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.
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Visual Analog Scale (VAS)
Časové okno: Baseline and 1 month after completion of treatment
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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.
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Baseline and 1 month after completion of treatment
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Dallas Pain Questionnaire (DPQ)
Časové okno: Baseline and 1 month after completion of treatment
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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.
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Baseline and 1 month after completion of treatment
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Studijní židle: Merve Dikici Yagli, Gaziosmanpasa Educational and Training Hospital
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- Benditz A, Thoma R. Coccygodynia-Diagnosis and Treatment. Dtsch Arztebl Int. 2025 Nov 14;122(23):638-644. doi: 10.3238/arztebl.m2025.0154.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
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