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

Not Applicable

Active, not recruiting

• Conditions: Coccyx Disorder

• Registration Number: NCT06754033
• Lead Sponsor: Superior University

Brief 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.

Study Timeline

• Study Start: 2024-02-01
• Primary Completion: 2024-08-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-30
• Last Update Submitted: 2024-12-30
• Study First Posted: 2024-12-31
• Last Update Posted: 2024-12-31
• Study Completion: 2025-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Adult patients with age 18-65 diagnosed with chronic coccydynia for at least 3 months were recruited.
• Participants who will be willing & able to adhere to the study protocol.
• Including participants who will be attending follow-up appointments & completing outcome measures.
• Participants who will be able to understand & provide written informed consent.
• Participants with a complete screening of other medical conditions and previous medical records.

Exclusion Criteria

• Participants with previous surgery on the coccyx or lumbosacral spine, pregnancy or breastfeeding, history of bleeding disorders or anticoagulant use, active infection, or significant medical condition that could pose a safety risk during the procedures (GIB or CESI) was omitted.
• Patients above the age of 65 were eliminated to reduce confounding by age-related health concerns and to provide a more homogenous study population for more accurate treatment outcomes.
• Participants with neurological conditions affecting pain perception or sensation were excluded.
• Participants with known allergies to medications used in the study (local anesthetic, steroid for injections) were not part of the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Numeric Pain Rating Scale (NPRS)	12 Months	Used as the primary outcome measure. Participants will rate their pain intensity on a scale of 0 to 10, with 0 indicating no pain and 10 indicating the worst possible pain. This measure will assess changes in pain levels from baseline through various follow-up points.
Oswestry Disability Index (ODI)	12 months	The Oswestry Disability Index will serve as the secondary outcome measure. This questionnaire evaluates the degree of disability experienced by participants due to their pain, focusing on various aspects of daily living and functional capacity. Additionally, the SF-12 health survey will be used to measure the overall health-related quality of life, providing further insights into the impact of the interventions.

Trial Locations

Locations (1)

Ghurkee Hospital; 🇵🇰 Lahore, Punjab, Pakistan