Skip to main content
OpenTrials
Completed

NCT Number: NCT07426497

Osteopathic Manual Therapy vs Ganglion Impar Block for Chronic Coccydynia: A Randomized Controlled Trial

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coccydynia Chronic Pain Coccygodynia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medicana Zincirlikuyu Hospital

Istanbul, Sisli, 34394, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Oswestry Disability Index (ODI) change from baseline

    Time frame: Baseline and 3 months

    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.

  2. Patient Global Impression of Change (PGIC) score

    Time frame: 3 weeks and 3 months

    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. Oswestry Disability Index (ODI) change at 3 weeks

    Time frame: Baseline and 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.

  4. Numeric Rating Scale (NRS) pain change at 3 weeks

    Time frame: Baseline and 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.

  5. Numeric Rating Scale (NRS) pain change at 3 months

    Time frame: Baseline and 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.

Sponsors and collaborators

Lead sponsor

Istanbul Medeniyet University

Other

Registry information

Official study title

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

Acronym: COCCY-OMT-GIB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.