Effect of Manipulation on Coccydynia

Not Applicable

Completed

• Conditions: Stretch; Pelvic Floor; Weak; Coccyx Disorder

• Registration Number: NCT05917366
• Lead Sponsor: KTO Karatay University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2022-07-16
• Primary Completion: 2022-12-20
• Study Completion: 2023-05-20
• Status Verified: 2023-06
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-15
• Last Update Submitted: 2023-06-15
• Study First Posted: 2023-06-23
• Last Update Posted: 2023-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from baseline in The Oswestry Disability Index at 4 weeks and 6 months	Baseline measurement before the treatment programs begin (pre-intervention), post-intervention at week 4, and 6 months follow-up	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.
Change from baseline in Pain at 4 weeks and 6 months	Baseline measurement before the treatment programs begin (pre-intervention), post-intervention at week 4, and 6 months follow-up	A visual analog scale (VAS) numbered 0-10 will be used in the assessment of pain.
Change from baseline in Paris questionnaire at 4 weeks and 6 months	Baseline measurement before the treatment programs begin (pre-intervention), post-intervention at week 4, and 6 months follow-up	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.

Trial Locations

Locations (1)

KTO Karatay University; 🇹🇷 Konya, Turkey