Osteopathic Manual Therapy vs Ganglion Impar Block for Chronic Coccydynia (COCCY-OMT-GIB)

Comparison of Osteopathic Manual Therapy and Ganglion Impar Block in Patients With Chronic Coccydynia

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Coccygodynia; Coccydynia
• Intervention / Treatment: Procedure: Osteopathic Manual Therapy; Procedure: Ganglion Impar Block

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.

Primary outcome measures will include pain intensity assessed by the Numeric Rating Scale (NRS). Secondary outcomes will include 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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mert sancar, MD; Phone Number: +90 5076367611; Email: mrtsncr88@gmail.com
• Study Contact Backup: Name: Ekim Can Ozturk, Md; Phone Number: +90 5448294239; Email: ekimtrilogy@gmail.com

Study Locations

• Turkey (Türkiye)
  • Sisli
    • Istanbul, Sisli, Turkey (Türkiye), 34394
      • Recruiting
      • Medicana Zincirlikuyu Hospital
      • Contact: Mert Sancar, Md; Phone Number: +905076367611; Email: mrtsncr88@gmail.com
      • Contact: Ekim Can Ozturk, Md; Phone Number: +905448294239; Email: ekimtrilogy@gmail.com
      • Principal Investigator: Mert Sancar, Md
      • Sub-Investigator: Ekim Can Ozturk, Md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Osteopathic Manual Therapy; 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; 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.
Experimental: Ganglion Impar Block; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Baseline 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.	Baseline and 3 weeks
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.	3 weeks and 3 months

Collaborators and Investigators

• Sponsor: Istanbul Medeniyet University

Study record dates

Study Major Dates

• Study Start (Actual): August 28, 2025
• Primary Completion (Actual): February 16, 2026
• Study Completion (Estimated): February 16, 2026

Study Registration Dates

• First Submitted: February 16, 2026
• First Submitted That Met QC Criteria: February 16, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Manual therapy; Numeric Rating Scale; Osteopathic manual therapy; Chronic coccydynia; Ganglion impar block; Coccyx pain; Interventional pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Chronic Pain
• Other Study ID Numbers: COCCY-OMT-GIB-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No