The Effect of USG-Guided Coccygeal Nerve Block on Sacrococcygeal And/or Intercoccygeal Joint Injection for Coccydynia

NCT05683262 | Completed

• 1 other identifier: E-83041234-604.16.01-8011
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Coccydynia refers to a significant pain, that does not radiate, in and around the coccyx region. This symptom is typically worsen while sitting, especially on hard surfaces, standing up from sitting position and standing for long time. The steroid and anesthetic injection to the sacrococcygeal, intercoccygeal joints and impar ganglions are the most commonly cited second line management option in the literatures for refractor cases. The coccygeal nerve blockade or radiofrequency ablation is also used for coccydynia especially for traumatic cases. The aim of the study is; to evaluate the efficacy of ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection in coccydynia and to investigate whether coccygeal nerve blockade has an additional contribution to this treatment.

Conditions

Coccyx Disorder; Coccygodynia; Coccyx Injury

Keywords

Coccydynia; Coccygeal nerve; Ultrasonography; Coccyx

Outcome Measures

Primary Outcomes (3)

• Change in pain severity of patients from baseline to each checkpoints

  Pain of the participants will be assessed by one of the most commonly used pain scale "numerical rating scale". It is numeric version of visual analog scale in which a patient selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing "no pain" to '10' representing "pain as bad as you can imagine". Participant is asked to indicate rates of their pain on the day of presentation during palpation of coccyx, at the first sitting, sitting on soft and hard surface, standing up from sitting position, standing for long time, during defecation, sexual intercourse and menstrual cycle, and also 1 week, 4 weeks, 3 moths and 6 months after the injection for each. Participant is also asked to indicate rates of their pain one hour after the injection during sitting, standing up from sitting position and on palpation of coccyx.

  From pre-interventional time to post-interventional 1st hour, first week, 4th week, 3rd month, 6th moth

• Change in pain-free sitting time of patients from baseline to each checkpoints

  Participant is asked to indicate pain-free sitting time as a minute on the day of presentation, and one hour, 1 week, 4 weeks, 3 moths and 6 months after the injection. Longer duration indicating better result.

  From pre-interventional time to post-interventional 1st hour, first week, 4th week, 3rd month, 6th moth

• Pain according to NRS during injection

  the pain elicited by injection is asked to participants to determine effect of coccygeal nerve block after one hour of injection. The score ranges from 0 to 10, with 0 indicating "No Pain" and 10 "Worst Imaginable Pain

  1st hour

Secondary Outcomes (2)

• Change the patient reported quality of life assessment from baseline to each checkpoints

  From pre-interventional time to post-interventional 4th week, 3rd month, 6th moth

• Change the patient reported disability from baseline to each checkpoints

  From pre-interventional time to post-interventional 4th week, 3rd month, 6th moth

Study Arms (2)

Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection

ACTIVE COMPARATOR

Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection is applied to patients in this group

Procedure: Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection

Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection with coccygeal nerve block

ACTIVE COMPARATOR

Ultrasound-guided coccygeal nerve blockade is done before the application of ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection to patients in this group

Procedure: Ultrasound-guided coccygeal nerve block; Procedure: Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection after coccygeal nerve block

Interventions

Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection PROCEDURE

Ultrasound guidance is used for correct visualization of injection site, and so obtained more successful results. Patients are placed in the prone position with a pillow under the abdomen to flatten the lumbar curvature. Lower extremities should be internally rotated while feet are inverted to help flatten the gluteal region. Injection site is cleaned thrice with povidone iodine %10 solution and covered with sterile drapes. Ultrasonography gel was applied on the probe and the probe was wrapped with a transparent thin sheath and cleaned with povidone iodine. Sterile gel is applied on the skin. The sacrococcygeal ligament, the sacrococcygeal and intercoccygeal joints were visualized. The sacrococcygeal and/or intercoccygeal joints were entered using the in-plane technique with a 23 gauge 6 cm long needle. When it was seen that the needle tip was inside the joint, 3 cc of 2% lidocaine + 1 cc betamethasone solution was injected.

Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection

Ultrasound-guided coccygeal nerve block PROCEDURE

Patients are placed in the prone position with a pillow under the abdomen. Lower extremities are internally rotated while feet are inverted. Injection site and the probe are cleaned thrice with povidone iodine %10 solution. Sterile gel is applied. The prob was placed on coccygeal cornu and the coccygeal nerve was visualized superomedial to the CC in the subcutaneous tissue layer. Hydrodissection was made by administering 5 ml of 5% dextrose + 1 ml of 2% lidocaine via an in-plane approach with a 23 gauge 6 cm long needle, targeting the short axes of the bilateral coccygeal nerves.

Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection with coccygeal nerve block

Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection after coccygeal nerve block PROCEDURE

After the coccygeal nerve block, when the pain with palpation of the coccygeal region was reduced by at least 50%, the sacrococcygeal ligament, sacrococcygeal and intercoccygeal joints were visualized.The sacrococcygeal and/or intercoccygeal joints were entered using the in-plane technique with a 23 gauge 6 cm long needle. When the needle tip was inside the joint, 3 cc of 2% lidocaine + 1 cc betamethasone solution was injected.

Ultrasound-guided sacrococcygeal and/or intercoccygeal joint injection with coccygeal nerve block

Eligibility Criteria

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

You may qualify if:

• Aged 18-65 years
• Patients who have coccygeal pain and have not benefited from conservative treatment
• Be able to understand enough Turkish to complete the outcome questionnaire
• Patients whose informed consent was obtained for participation in the study

You may not qualify if:

• Fibromyalgia
• History of surgery for coccydynia
• Pregnancy or breastfeeding
• Inflammatory disease which effect the spine
• Malignancy
• Coagulation disorders
• Infection

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Farih Sultan Mehmet Training and Research Hospital

Istanbul, Istanbul, 34752, Turkey (Türkiye)

Location

Related Publications (7)

• Sencan S, Edipoglu IS, Ulku Demir FG, Yolcu G, Gunduz OH. Are steroids required in the treatment of ganglion impar blockade in chronic coccydynia? a prospective double-blinded clinical trial. Korean J Pain. 2019 Oct 1;32(4):301-306. doi: 10.3344/kjp.2019.32.4.301.

  PMID: 31569923 BACKGROUND

• Garg B, Ahuja K. Coccydynia-A comprehensive review on etiology, radiological features and management options. J Clin Orthop Trauma. 2021 Jan;12(1):123-129. doi: 10.1016/j.jcot.2020.09.025. Epub 2020 Sep 24.

  PMID: 33716437 BACKGROUND

• Mitra R, Cheung L, Perry P. Efficacy of fluoroscopically guided steroid injections in the management of coccydynia. Pain Physician. 2007 Nov;10(6):775-8.

  PMID: 17987101 BACKGROUND

• Datir A, Connell D. CT-guided injection for ganglion impar blockade: a radiological approach to the management of coccydynia. Clin Radiol. 2010 Jan;65(1):21-5. doi: 10.1016/j.crad.2009.08.007. Epub 2009 Oct 24.

  PMID: 20103417 BACKGROUND

• Woon JT, Stringer MD. Clinical anatomy of the coccyx: A systematic review. Clin Anat. 2012 Mar;25(2):158-67. doi: 10.1002/ca.21216. Epub 2011 Jul 7.

  PMID: 21739475 BACKGROUND

• Chen Y, Huang-Lionnet JHY, Cohen SP. Radiofrequency Ablation in Coccydynia: A Case Series and Comprehensive, Evidence-Based Review. Pain Med. 2017 Jun 1;18(6):1111-1130. doi: 10.1093/pm/pnw268.

  PMID: 28034983 BACKGROUND

• Wu WT, Hsu YC, Chang KV, Ozcakar L. Ultrasound Imaging and Ultrasound-Guided Injection of the Coccygeal Nerve for Coccydynia. Am J Phys Med Rehabil. 2022 Jul 1;101(7):e108-e109. doi: 10.1097/PHM.0000000000001987. Epub 2022 Feb 23. No abstract available.

  PMID: 35220319 BACKGROUND

Study Officials

• Feyza Unlu Ozkan

  Fatih Sultan Mehmet Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised, Double Blind Study

Study Record Dates

• First Submitted: December 24, 2022
• First Posted: January 13, 2023
• Study Start: June 15, 2023
• Primary Completion: December 28, 2023
• Study Completion: June 18, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)