Coccyx InjuriesNCT05047380
The Relationship of Disability With Depression, Anxiety and Sleep Quality in Patients With Coccygodynia
An observational study of Coccyx Injuries and Pain, Chronic, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Coccyx Injuries, Pain, Chronic, Anxiety
- What is being tested?
- Owstery Disability Scale for disability Beck Depression Scale, Beck Anxiety Scale for psychological evaluation, VAS for pain, Pittsburgh Sleep Quality Scale for sleep quality
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 54 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 30 Apr 2022
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Diagnosed with coccygodynia
- Agreement to take part in the study 18 to 70 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Emel Guler
Sivas
emel guler, +905356492951, emelguler@cumhuriyet.edu.tr
About this study
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.
Read the detailed description
Coccygodynia often develops from an inappropriate sitting position or when standing up from a sitting position. In the advanced stages of coccygodynia the pain becomes continuous. Pain can be triggered by walking or standing for a long time. Patients may experience sacrococcygeal pain in the supine position and during sleep. It has been argued that the coexistence of coccygodynia and psychiatric disease is caused by the excessive activity of the pelvic region nerves. In addition, it has been stated that stress, depression and fear may lead to increased spasm in the pelvic floor muscles.It is stated in the literature that 62.9-75% of patients with chronic pain have at least one psychiatric disorder. The most common psychiatric comorbidities in patients with chronic pain are; major depression, somatoform disorders, and generalized anxiety disorder. The relationship between pain and psychological variables has been attributed to the fact that the sensorial pathways of pain and mood regulation are located in the same region of the brain. In addition, common neurotransmitters such as serotonin, norepinephrine and dopamine are present in the pathophysiology of depression and pain.There is a bidirectional relationship between sleep and pain. In recent studies; It has been reported that sleep disorder causes pain development rather than the effect of pain on sleep disorder.
54 patients with coccydynia will be recruited prospectively according to the appropriate inclusion and exclusion criteria.Within the scope of the study, the age, gender, duration of symptoms, etiology of coccygodynia, and severity of pain will be recorded. 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.
The data will be entered into the SPSS (version: 22.0) IBM SPSS statistical package program. Arithmetic mean, standard deviation, min-max, median values will be given in the data obtained by measurement. Percentage and frequency distribution will be given in the data obtained by counting. In statistical evaluations, parametric tests will be used for normally distributed data, and non-parametric tests will be used for data not normally distributed. Relationships will be compared according to the Pearson or Spearman correlation coefficient. Chi-square test will be applied to categorical data. P<0.05 will be considered significant.
- Conditions
- Coccyx Injuries, Pain, Chronic, Anxiety, Depression, Sleep, Sleep Hygiene
- Being tested
- Owstery Disability Scale for disability Beck Depression Scale, Beck Anxiety Scale for psychological evaluation, VAS for pain, Pittsburgh Sleep Quality Scale for sleep quality
- Keywords
- coccyx, chronic pain, depression, anxiety, sleep hygiene
- Medical subject headings
- Chronic Pain, Anxiety Disorders, Depression, Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Owstery Disability Scale for disability Beck Depression Scale, Beck Anxiety Scale for psychological evaluation, VAS for pain, Pittsburgh Sleep Quality Scale for sleep qualityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| coccycodinia group | A total of 54 patients diagnosed with coccycodinia Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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".
Measured: The study will be completed in 9 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start1 Aug 2021
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coccyx InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Cumhuriyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel Güler, Cumhuriyet University
- Investigators
- Emel Güler, MD, Principal investigator, Cumhuriyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05047380
- Sponsor's protocol ID
- 2021-06/20
- Status last verified
- Sep 2021
- First submitted
- 31 Aug 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27037436
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Disability With Depression, Anxiety and Sleep Quality in Patients With Coccygodynia
- ClinicalTrials.gov ID
- NCT05047380
- Acronym / sponsor ID
- 2021-06/20
- Conditions
- Coccyx Injuries, Pain, Chronic, Anxiety, Depression, Sleep, Sleep Hygiene
- Keywords
- coccyx, chronic pain, depression, anxiety, sleep hygiene
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Coccygodynia often develops from an inappropriate sitting position or when standing up from a sitting position. In the advanced stages of coccygodynia the pain becomes continuous. Pain can be triggered by walking or standing for a long time. Patients may experience sacrococcygeal pain in the supine position and during sleep. It has been argued that the coexistence of coccygodynia and psychiatric disease is caused by the excessive activity of the pelvic region nerves. In addition, it has been stated that stress, depression and fear may lead to increased spasm in the pelvic floor muscles.It is stated in the literature that 62.9-75% of patients with chronic pain have at least one psychiatric disorder. The most common psychiatric comorbidities in patients with chronic pain are; major depression, somatoform disorders, and generalized anxiety disorder. The relationship between pain and psychological variables has been attributed to the fact that the sensorial pathways of pain and mood regulation are located in the same region of the brain. In addition, common neurotransmitters such as serotonin, norepinephrine and dopamine are present in the pathophysiology of depression and pain.There is a bidirectional relationship between sleep and pain. In recent studies; It has been reported that sleep disorder causes pain development rather than the effect of pain on sleep disorder.
54 patients with coccydynia will be recruited prospectively according to the appropriate inclusion and exclusion criteria.Within the scope of the study, the age, gender, duration of symptoms, etiology of coccygodynia, and severity of pain will be recorded. 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.
The data will be entered into the SPSS (version: 22.0) IBM SPSS statistical package program. Arithmetic mean, standard deviation, min-max, median values will be given in the data obtained by measurement. Percentage and frequency distribution will be given in the data obtained by counting. In statistical evaluations, parametric tests will be used for normally distributed data, and non-parametric tests will be used for data not normally distributed. Relationships will be compared according to the Pearson or Spearman correlation coefficient. Chi-square test will be applied to categorical data. P<0.05 will be considered significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coccycodinia group | – | Behavioral: Owstery Disability Scale for disability Beck Depression Scale, Beck Anxiety Scale for psychological evaluation, VAS for pain, Pittsburgh Sleep Quality Scale for sleep qualityA total of 54 patients diagnosed with coccycodinia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Diagnosed with coccygodynia
- Agreement to take part in the study 18 to 70 years old
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Owstery Disability Scale for disability Beck Depression Scale, Beck Anxiety Scale for psychological evaluation, VAS for pain, Pittsburgh Sleep Quality Scale for sleep qualityAll 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. | Behavioural | coccycodinia group |
Primary outcome
Anxiety and depression
Time frame: The study will be completed in 9 months.
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.
Sleep quality
Time frame: The study will be completed in 9 months.
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".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Background: PubMed 27037436Hanley 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.
- preoperative psychiatric disorders were detected in most of the patients who underwent coccygectomy.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emel Güler, MD principal investigator
Cumhuriyet University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coccyx Injuries and Pain, Chronic, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emel Güler, MD (+905356492951, dremelguler@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and depression (time frame: The study will be completed in 9 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05047380, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.