Effect of Manipulation on Coccydynia

Stretch Clinical Trial

Official title:

The Effectiveness of Manipulation in Combination With Exercise for Patients With Coccydynia: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05917366
• Other study ID #: KaratayManipulation
• Status: Completed
• Phase: N/A
• Start date: July 16, 2022
• Est. completion date: May 20, 2023

Study information

• Verified date: June 2023
• Source: KTO Karatay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study was to investigate the efficacy of manipulation combined with exercise as a treatment for patients with coccydynia.

Description:

Subject: Coccydynia is a painful condition characterized by inflammation and discomfort in the coccyx region, commonly known as the tailbone. It can significantly affect an individual's quality of life by impairing their ability to sit, stand, or engage in daily activities. Various treatment approaches have been explored to alleviate the symptoms of coccydynia, including manipulation techniques and exercise interventions. However, to date, there is a scarcity of research investigating the combined effects of manipulation and exercise for patients with coccydynia. Purpose: The purpose of this study is to evaluate the efficacy of combining manipulation techniques with exercise interventions for patients diagnosed with coccydynia, a painful condition affecting the coccyx region. Despite the debilitating impact of coccydynia on daily activities and quality of life, there is a limited understanding of the optimal treatment approach for this condition. This study aims to address this knowledge gap by investigating the potential benefits of combining manipulation and exercise in managing coccydynia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: May 20, 2023
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

Inclusion Criteria:

• chronic (3 months) coccydynia
• age over 25 and under 60 years
• no ongoing antidepressant treatment
• no medicolegal litigation or occupational-accident etiology

Exclusion Criteria:

• undergoing an operation aimed at the anal area
• those with additional diseases such as radiculopathy etc.

Related Conditions & MeSH terms

• Pelvic Floor; Weak
• Stretch

Intervention

Other:
• Exercises
Stretching exercise for the piriformis and iliopsoas muscles. strengthening exercises for pelvic floor muscles
• Coccyx Manipulation
Application of manipulation to relax the levetor ani muscle

Locations

Country	Name	City	State
Turkey	KTO Karatay University	Konya

Sponsors (1)

Lead Sponsor	Collaborator
KTO Karatay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Pain at 4 weeks and 6 months	A visual analog scale (VAS) numbered 0-10 will be used in the assessment of pain.	Baseline measurement before the treatment programs begin (pre-intervention), post-intervention at week 4, and 6 months follow-up
Primary	Change from baseline in Paris questionnaire at 4 weeks and 6 months	Coccydynia-related symptoms were recorded using the Paris questionnaire, ranging from 0 (no symptoms) to 10 (maximum symptoms). The Paris questionnaire is a specific assessment tool designed to evaluate symptoms and functional limitations related to coccydynia, a condition characterized by pain in the coccyx region. The questionnaire consists of a series of questions that inquire about the severity and impact of coccyx pain on various activities and daily life.	Baseline measurement before the treatment programs begin (pre-intervention), post-intervention at week 4, and 6 months follow-up
Primary	Change from baseline in The Oswestry Disability Index at 4 weeks and 6 months	The Oswestry Disability Index consists of ten sections, each addressing a different aspect of functional ability, including pain intensity, lifting, ability to walk, ability to sit, ability to stand, sleep quality, ability to socialize, ability to travel, ability to perform self-care tasks, and ability to perform household tasks. Each section contains multiple statements, and the individual rates their level of disability on a scale of 0 to 5, with higher scores indicating greater disability.	Baseline measurement before the treatment programs begin (pre-intervention), post-intervention at week 4, and 6 months follow-up