An interventional study of Osteopathic Manual Therapy and Ganglion Impar Block in Coccydynia, Chronic Pain and Coccygodynia, sponsored by Istanbul Medeniyet University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-24.
Sponsored by Istanbul Medeniyet University · Not applicable, Interventional, and Treatment
Chronic coccydynia is a condition characterized by persistent pain in the coccyx region that can significantly impair sitting tolerance, daily activities, and quality of life. Various conservative and interventional treatment options have been described, including manual therapy techniques and ganglion impar block. However, the comparative effectiveness of these approaches remains unclear.
The aim of this randomized controlled study is to compare the effects of osteopathic manual therapy and ganglion impar block on pain intensity and functional disability in patients with chronic coccydynia. Participants will be randomly assigned to one of the two treatment groups. Pain severity will be assessed using the Numeric Rating Scale (NRS), and functional status will be evaluated with the Oswestry Disability Index (ODI) at baseline, week 3, and month 3.
The results of this study are expected to provide evidence regarding the relative effectiveness of these two commonly used treatment methods and to guide clinicians in selecting appropriate management strategies for patients with chronic coccydynia.
Chronic coccydynia is a multifactorial pain syndrome affecting the coccygeal region and is often associated with trauma, prolonged sitting, obesity, or idiopathic causes. Patients frequently report severe localized pain that worsens with sitting and transitions from sitting to standing. Conservative treatment options include physical therapy modalities and manual therapy techniques, while interventional procedures such as ganglion impar block are commonly used in refractory cases.
This prospective randomized controlled trial aims to compare the clinical effectiveness of osteopathic manual therapy and ganglion impar block in patients with chronic coccydynia. Eligible patients will be randomly allocated into two groups. The osteopathic manual therapy group will receive standardized manual therapy sessions targeting pelvic alignment, sacrococcygeal mobility, and surrounding soft tissue structures. The ganglion impar block group will undergo fluoroscopy-guided ganglion impar injection performed under sterile conditions.
The outcome measures will include pain intensity assessed by the Numeric Rating Scale (NRS) and functional disability assessed by the Oswestry Disability Index (ODI). Assessments will be performed at baseline, week 3, and month 3 follow-up.
The study is conducted at Medicana Zincirlikuyu Hospital in collaboration with Istanbul Atlas University. Ethical approval has been obtained from the Istanbul Atlas University Clinical Research Ethics Committee. The findings of this trial will contribute to the evidence base regarding non-surgical management options for chronic coccydynia.
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This study's enrollment of 105 is above the median of 60 across 2,160 interventional studies indexed under Chronic Pain.
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Exclusion Criteria:
Participants received osteopathic manual therapy targeting the coccygeal and sacrococcygeal region. Techniques included myofascial release, ligamentous tension balancing, and gentle mobilization. Treatment was applied once weekly for 3 weeks.
Procedure: Osteopathic Manual Therapy
Participants received a single ganglion impar block performed under fluoroscopic guidance using local anesthetic with corticosteroid. No additional manual therapy was applied.
Procedure: Ganglion Impar Block
Osteopathic manual therapy was applied to the sacrococcygeal region. Techniques included myofascial release, ligamentous tension balancing, and gentle mobilization. Treatment was performed once weekly for three consecutive weeks by a certified practitioner.
A single ganglion impar block was performed under fluoroscopic guidance using local anesthetic combined with corticosteroid. The procedure was carried out under sterile conditions without additional manual therapy.
Oswestry Disability Index (ODI) change from baseline
Change in functional disability measured by the Oswestry Disability Index (ODI, 0-100; 0 = no disability, 100 = maximum disability; higher scores indicate worse disability). Mean change from baseline to 3 months will be compared between groups.
Time frame: Baseline and 3 months
Patient Global Impression of Change (PGIC) score
Patient Global Impression of Change (PGIC; 7-point scale from 1 = very much improved to 7 = very much worse; lower scores indicate better outcome). Mean PGIC score will be compared between groups.
Time frame: 3 weeks and 3 months
Oswestry Disability Index (ODI) change at 3 weeks
Change in functional disability measured by the Oswestry Disability Index (ODI, 0-100; higher scores indicate worse disability). Mean change from baseline to 3 weeks will be compared between groups.
Time frame: Baseline and 3 weeks
Numeric Rating Scale (NRS) pain change at 3 weeks
Change in pain intensity measured by the Numeric Rating Scale (NRS, 0-10; 0 = no pain, 10 = worst imaginable pain; higher scores indicate worse pain). Mean change from baseline to 3 weeks will be compared between groups.
Time frame: Baseline and 3 weeks
Numeric Rating Scale (NRS) pain change at 3 months
Change in pain intensity measured by the Numeric Rating Scale (NRS, 0-10; higher scores indicate worse pain). Mean change from baseline to 3 months will be compared between groups.
Time frame: Baseline and 3 months
Plan to share: No
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Istanbul Medeniyet University