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

NCT06754033 | Active Not Recruiting DMC

• 1 other identifier: MSRSW/Batch-Fall22/766
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Coccyx Disorder

Outcome Measures

Primary Outcomes (2)

• Numeric Pain Rating Scale (NPRS)

  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.

  12 Months

• Oswestry Disability Index (ODI)

  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.

  12 months

Study Arms (2)

Interventional group I

EXPERIMENTAL

Diagnostic Test: Interventional group I

Interventional group II

ACTIVE COMPARATOR

Combination Product: Interventional group II

Interventions

Interventional group I DIAGNOSTIC_TEST

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.

Interventional group I

Interventional group II COMBINATION_PRODUCT

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.

Interventional group II

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Superior University: lead

Study Sites (1)

Ghurkee Hospital

Lahore, Punjab Province, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 31, 2024
• Study Start: February 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: January 31, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)