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Completed

NCT Number: NCT05917366

Effect of Manipulation on Coccydynia

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

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Key information

Conditions

Coccyx Disorder Asthenia Pathological Conditions, Signs and Symptoms Pelvic Floor; Weak Signs and Symptoms Stretch

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KTO Karatay University

Konya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercises

Other

Stretching exercise for the piriformis and iliopsoas muscles. strengthening exercises for pelvic floor muscles

Coccyx Manipulation

Other

Application of manipulation to relax the levetor ani muscle

Primary outcomes

  1. Change from baseline in Pain at 4 weeks and 6 months

    Time frame: 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.

  2. Change from baseline in Paris questionnaire at 4 weeks and 6 months

    Time frame: 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.

  3. Change from baseline in The Oswestry Disability Index at 4 weeks and 6 months

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

KTO Karatay University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jun 23, 2023
Registry last updated
Jun 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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