NCT05047380

Brief Summary

Pain of the sacrococcygeal region is called coccygodynia This painful clinical picture, which causes a decrease in the quality of life, also causes disability. Coccycodynia has been associated with hysteria, neurosis, and depression. In some studies, it has been reported that it should be evaluated in somatization in coccygodynia. There are a few studies examining the relationship between coccygodynia and psychiatric disorders.There is no study in the literature examining coccygodynia and sleep. There may be a relationship between pelvic floor muscle spasm in the etiology of coccygodynia and sleep quality. In this study, it is aimed to investigate the relationship between disability severity and anxiety, depression and sleep quality in patients with coccygodynia.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 31, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 17, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2022

Completed
Last Updated

September 27, 2021

Status Verified

September 1, 2021

Enrollment Period

9 months

First QC Date

August 31, 2021

Last Update Submit

September 21, 2021

Conditions

Keywords

coccyxchronic paindepressionanxietysleep hygiene

Outcome Measures

Primary Outcomes (2)

  • Anxiety and depression

    Beck Depression Scale will be used in depression interrogation. ≤9 points are classified as normal,10-16 points as mild depression,17-29 points as moderate depression, and 30-63 points as severe depression.Beck Anxiety Scale will be used in anxiety interrogation. ≤9 points are classified as normal, 10-18 points as mild anxiety, 19-29 points as moderate anxiety, and 30-63 points as severe anxiety.

    The study will be completed in 9 months.

  • Sleep quality

    Sleep quality will be questioned with The Pittsburgh Sleep Quality Index. Those who score ˃5 have poor sleep quality, and those who score ≤5 have "good sleep quality".

    The study will be completed in 9 months.

Study Arms (1)

coccycodinia group

A total of 54 patients diagnosed with coccycodinia

Behavioral: Owstery Disability Scale for disability Beck Depression Scale, Beck Anxiety Scale for psychological evaluation, VAS for pain, Pittsburgh Sleep Quality Scale for sleep quality

Interventions

All assessments will be made using questionairres. The Oswestry Disability Index scale will be filled in to assess the severity of disability resulting from pain in the patient. Pain severity will be evaluated with the Visual Analog Scale (VAS). Depression and anxiety assessment will be made with Beck Depression Scale and Beck Anxiety Scale, respectively. Sleep quality will be evaluated with the Pittsburg Sleep Quality Index.

coccycodinia group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who applied to Sivas Cumhuriyet University Faculty of Medicine, Physical Therapy and Rehabilitation Clinic between 01/08/2021-30/04/2022 and diagnosed with coccygodynia will be included in the study

You may qualify if:

  • Diagnosed with coccygodynia
  • Agreement to take part in the study 18 to 70 years old

You may not qualify if:

  • Presence of cognitive impairment that would limit answering the questions in the questionnaires
  • History of psychotic disorder
  • History of neurological disease (cerebrovascular accident, polyneuropathy, parkinson's, dementia, epilepsy),
  • History of rheumatological disease, fibromyalgia and malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emel Guler

Sivas, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • Hanley EN, Ode G, Jackson Iii BJ, Seymour R. Coccygectomy for patients with chronic coccydynia: a prospective, observational study of 98 patients. Bone Joint J. 2016 Apr;98-B(4):526-33. doi: 10.1302/0301-620X.98B4.36641.

    PMID: 27037436BACKGROUND

Related Links

MeSH Terms

Conditions

Chronic PainAnxiety DisordersDepressionSleep Hygiene

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavioral SymptomsBehaviorHealth Behavior

Study Officials

  • Emel Güler, MD

    Cumhuriyet University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hanzade A Ünal-Artık, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 31, 2021

First Posted

September 17, 2021

Study Start

August 1, 2021

Primary Completion

April 30, 2022

Study Completion

April 30, 2022

Last Updated

September 27, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations