Stretch Clinical Trial
Official title:
The Effectiveness of Manipulation in Combination With Exercise for Patients With Coccydynia: A Randomized Controlled Trial
Verified date | June 2023 |
Source | KTO Karatay University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study was to investigate the efficacy of manipulation combined with exercise as a treatment for patients with coccydynia.
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | KTO Karatay University | Konya |
Lead Sponsor | Collaborator |
---|---|
KTO Karatay University |
Turkey,
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 |
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