NCT06754033

Ganglion Impar Block With Physical Therapy vs Caudal Epidural Steroid Injection With PT for Patients With Coccydynia

Comparison of Ganglion Impar Block With Physical Therapy Versus Caudal Epidural Steroid Injection With Physical Therapy for Patients With Coccydynia

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Superior University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate the efficacy of two treatment modalities for patients suffering from coccydynia: Ganglion Impar Block (GIB) combined with physical therapy, and Caudal Epidural Steroid Injection (CESI) also accompanied by physical therapy. Coccydynia, characterized by pain in the coccygeal region, can significantly impair daily functioning and quality of life.

Detailed description

Participants were assessed using various outcome measures, including the SF-12, Oswestry Disability Index (ODI), and Numeric Pain Rating Scale (NPRS). Data collection will occur at baseline and through four follow-up points over 16 weeks, allowing for a comprehensive evaluation of both immediate and long-term treatment effects. By comparing these two interventions, the study seeks to determine which approach yields superior results in alleviating pain and improving functional outcomes for patients with coccydynia, thereby contributing valuable insights into the management of this condition.

Conditions

• Coccyx Disorder

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Interventional group I	Intervention Details: Participants in this arm will receive a Ganglion Impar Block, a minimally invasive injection aimed at blocking pain signals from the coccyx region (Ganglion Impar Block using Triamcinolone Acetate (40 mg) and Bupivacaine (0.25%) administered with a 22G Spinal Needle under Fluoroscopic Guidance). Participants in this arm will receive a Ganglion Impar Block, a minimally invasive procedure involving the administration of Triamcinolone Acetate (a corticosteroid) and Bupivacaine (a local anesthetic). This is intended to block pain signals originating from the coccyx region. The procedure will be conducted under fluoroscopic guidance to ensure precise delivery. The injection will be complemented by a structured physical therapy program, including heat therapy, ultrasound, posture training, core strengthening exercises, and mobility activities to improve pain relief and functional capacity.
COMBINATION_PRODUCT	Interventional group II	Intervention Details: Participants in this arm will receive a Caudal Epidural Steroid Injection Caudal Epidural Steroid Injection using Triamcinolone Acetate (40 mg), Bupivacaine (0.25%), and Normal Saline (6 mL) administered with a 22G Spinal Needle under Fluoroscopic Guidance), designed to deliver anti-inflammatory medication directly to the epidural space, thereby reducing inflammation and pain. This will also be paired with a tailored physical therapy program, focusing on similar modalities as in Arm 1, including heat therapy, ultrasound, posture training, and strengthening exercises. The objective is to enhance pain relief and functional recovery in the context of coccydynia.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-08-01
• Completion: 2025-01-31
• First posted: 2024-12-31
• Last updated: 2024-12-31

Locations

1 site across 1 country: Pakistan