Effect of Manipulation on Coccydynia

NCT05917366 | Completed

• 1 other identifier: KaratayManipulation
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coccyx Disorder; Pelvic Floor; Weak; Stretch

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Coccyx Manipulation

EXPERIMENTAL

Manual therapy sessions, in addition to the exercise group, were performed once a week for four weeks.

Other: Exercises; Other: Coccyx Manipulation

Exercises

ACTIVE COMPARATOR

A total of 4 sessions were applied, 3 times a week.

Other: Exercises

Interventions

Exercises OTHER

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

Coccyx Manipulation; Exercises

Coccyx Manipulation OTHER

Application of manipulation to relax the levetor ani muscle

Coccyx Manipulation

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• KTO Karatay University: lead

Study Sites (1)

KTO Karatay University

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Asthenia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Bayram Sönmez ÜNÜVAR

  KTO KARATAY UNIVERSTESI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 23, 2023
• Study Start: July 16, 2022
• Primary Completion: December 20, 2022
• Study Completion: May 20, 2023
• Last Updated: June 23, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)