Coccydynia, Chronic Pain, Coccygodynia
Conditions
Keywords
Chronic coccydynia, Ganglion impar block, Osteopathic manual therapy, Coccyx pain, Manual therapy, Interventional pain, Numeric Rating Scale
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREOsteopathic Manual Therapy
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.
PROCEDUREGanglion Impar Block
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.
Sponsors
Istanbul Medeniyet University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-75 years * Chronic coccygodynia ≥3 months * Baseline NRS ≥4 * ODI ≥20 * Failure of prior conservative treatment * Imaging excludes fracture, infection, or malignancy * Ability to provide written informed consent
Exclusion criteria
* Acute coccygodynia * Prior spinal or coccygeal surgery * Malignancy * Pelvic fracture * Pregnancy * Coagulation disorder * Severe psychiatric disease * Prior osteopathic manual therapy or ganglion impar block
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) change at 3 months after treatment completion | Baseline and 3 months after treatment completion | Change in functional disability measured using the Oswestry Disability Index (ODI), scored from 0 to 100, with higher scores indicating greater disability. Change from baseline to 3 months after treatment completion is compared between groups. Treatment completion is defined as the last session of the three-session osteopathic manual therapy (OMT) protocol or the single ganglion impar block (GIB) procedure, according to treatment allocation. |
| Oswestry Disability Index (ODI) change at week 3 | Baseline and week 3 | Change in functional disability measured using the Oswestry Disability Index (ODI), scored from 0 to 100, with higher scores indicating greater disability. Change from baseline to week 3 is compared between groups. The week-3 assessment coincides with completion of the three-session osteopathic manual therapy (OMT) protocol and occurs approximately 3 weeks after the single ganglion impar block (GIB) procedure. |
| Numeric Rating Scale (NRS-11) pain change at week 3 | Baseline and week 3 | Change in pain intensity measured using the 11-point Numeric Rating Scale (NRS-11), scored from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity. Change from baseline to week 3 is compared between groups. The week-3 assessment coincides with completion of the three-session osteopathic manual therapy (OMT) protocol and occurs approximately 3 weeks after the single ganglion impar block (GIB) procedure. |
| Numeric Rating Scale (NRS-11) pain change at 3 months after treatment completion | Baseline and 3 months after treatment completion | Change in pain intensity measured using the 11-point Numeric Rating Scale (NRS-11), scored from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity. Change from baseline to 3 months after treatment completion is compared between groups. Treatment completion is defined as the last session of the three-session osteopathic manual therapy (OMT) protocol or the single ganglion impar block (GIB) procedure, according to treatment allocation. |
Countries
Turkey (Türkiye)
Outcome results
None listed