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

S

Superior University

Status

Active, not recruiting

Conditions

Coccyx Disorder

Treatments

Diagnostic Test: Interventional group I
Combination Product: Interventional group II

Study type

Interventional

Funder types

Other

Identifiers

NCT06754033
MSRSW/Batch-Fall22/766

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

42 participants in 2 patient groups

Interventional group I
Experimental group
Treatment:
Diagnostic Test: Interventional group I
Interventional group II
Active Comparator group
Treatment:
Combination Product: Interventional group II

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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