Effect of Manipulation on Coccydynia

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

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

Study Overview

• Status: Completed
• Conditions: Stretch; Coccyx Disorder; Pelvic Floor; Weak
• Intervention / Treatment: Other: Exercises; Other: Coccyx Manipulation

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 Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Konya, Turkey
    • KTO Karatay University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Coccyx Manipulation; Manual therapy sessions, in addition to the exercise group, were performed once a week for four weeks.	Other: Exercises; Stretching exercise for the piriformis and iliopsoas muscles. strengthening exercises for pelvic floor muscles; Other: Coccyx Manipulation; Application of manipulation to relax the levetor ani muscle
Active Comparator: Exercises; A total of 4 sessions were applied, 3 times a week.	Other: Exercises; Stretching exercise for the piriformis and iliopsoas muscles. strengthening exercises for pelvic floor muscles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: KTO Karatay University
• Investigators: Principal Investigator: Bayram Sönmez ÜNÜVAR, KTO KARATAY UNIVERSTESI

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2022
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): May 20, 2023

Study Registration Dates

• First Submitted: June 6, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 23, 2023
• Last Update Submitted That Met QC Criteria: June 15, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: KaratayManipulation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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