Radial Extracorporeal Shockwave Therapy (rESWT) for Coccydynia: a Quasi-experimental Case Series

The aim of this study was to assess whether a pain-adapted protocol of rESWT is effective in treating coccydynia.

Study Overview

• Status: Completed
• Conditions: Coccyx Injury
• Intervention / Treatment: Other: ESWT

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥18 years
• VAS pain level ≥6
• Diagnosis of coccydynia (persistent pain in the coccygeal area consistent with coccydynia)

Exclusion Criteria:

• Age <18 years
• Local or systemic neurological disease
• Rheumatological disease
• Malignant disease
• Previous spinal surgery or spinal disease
• Coagulopathies
• Pregnancy
• VAS pain level <6
• Recent (≤6 weeks) trauma to the coccyx

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ESWT; Effect of ESWT in alleviating pain	Other: ESWT; ESWT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Management of coccydynia	Management of coccydynia (pain in the coccyx). The main presenting symptom is pain. its management is the primary goal of treatment. The pain VAS was used to monitor patient response and clinical improvement throughout treatment, with patients ranking the severity of their pain at rest, between "no pain" (0) and "worst imaginable pain" (10). Patients were asked their pain level before treatment at each session; although, this did not form part of our formal data collection. Treatment continued until patients reported a VAS pain level ≤3, at which point they were discharged from the clinic.	12 months

Collaborators and Investigators

• Sponsor: Barts & The London NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: March 1, 2023
• First Posted (Actual): March 3, 2023

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 30, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2016-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No