Osteopathic Manual Therapy vs Ganglion Impar Block for Chronic Coccydynia

NCT07426497 | Recruiting

• 1 other identifier: COCCY-OMT-GIB-2026
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Coccydynia; Chronic Pain; Coccygodynia

Keywords

Chronic coccydynia; Ganglion impar block; Osteopathic manual therapy; Coccyx pain; Manual therapy; Interventional pain; Numeric Rating Scale

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Numeric Rating Scale (NRS) pain change at 3 weeks

  Baseline and 3 weeks

• Numeric Rating Scale (NRS) pain change at 3 months

  Baseline and 3 months

• Oswestry Disability Index (ODI) change at 3 weeks

  Baseline and 3 weeks

• Patient Global Impression of Change (PGIC) score

  3 weeks and 3 months

Study Arms (2)

Osteopathic Manual Therapy

EXPERIMENTAL

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

Ganglion Impar Block

EXPERIMENTAL

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

Interventions

Osteopathic Manual Therapy PROCEDURE

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.

Osteopathic Manual Therapy

Ganglion Impar Block PROCEDURE

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.

Ganglion Impar Block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Acute coccygodynia
• Prior spinal or coccygeal surgery
• Malignancy
• Pelvic fracture
• Pregnancy
• Coagulation disorder
• Severe psychiatric disease
• Prior osteopathic manual therapy or ganglion impar block

Sponsors & Collaborators

• Istanbul Medeniyet University: lead

Study Sites (1)

Medicana Zincirlikuyu Hospital

Istanbul, Sisli, 34394, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

mert sancar, MD

CONTACT

5076367611; mrtsncr88@gmail.com

Ekim Can Ozturk, Md

CONTACT

5448294239; ekimtrilogy@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: February 23, 2026
• Study Start: August 28, 2025
• Primary Completion: February 16, 2026
• Study Completion: February 16, 2026
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)