Coccyx DisorderNCT05917366
Effect of Manipulation on Coccydynia
A study testing Exercises and Coccyx Manipulation in people with Coccyx Disorder and Pelvic Floor; Weak, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to investigate the efficacy of manipulation combined with exercise as a treatment for patients with coccydynia. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Coccyx Disorder, Pelvic Floor; Weak, Stretch
- What is being tested?
- Exercises and Coccyx Manipulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Jul 2022to 20 May 2023
- Phase
- Interventional
- 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 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- chronic (3 months) coccydynia
- age over 25 and under 60 years
- no ongoing antidepressant treatment
- no medicolegal litigation or occupational-accident etiology
Who cannot join
- undergoing an operation aimed at the anal area
- those with additional diseases such as radiculopathy etc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Manipulation in Combination With Exercise for Patients With Coccydynia: A Randomized Controlled Trial
The aim of this study was to investigate the efficacy of manipulation combined with exercise as a treatment for patients with coccydynia.
Read the detailed description
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.
- Conditions
- Coccyx Disorder, Pelvic Floor; Weak, Stretch
- Being tested
- Exercises, Coccyx Manipulation
- Medical subject headings
- Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesOther
Stretching exercise for the piriformis and iliopsoas muscles. strengthening exercises for pelvic floor muscles
Coccyx ManipulationOther
Application of manipulation to relax the levetor ani muscle
| Study group | Role | What they receive |
|---|---|---|
| Coccyx Manipulation | Experimental | Manual therapy sessions, in addition to the exercise group, were performed once a week for four weeks. Receives: Other: Exercises; Other: Coccyx Manipulation |
| Exercises | Active comparator | A total of 4 sessions were applied, 3 times a week. Receives: Other: Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline measurement before the treatment programs begin (pre-intervention), post-intervention at week 4, and 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start16 Jul 2022
- Primary completion20 Dec 2022
- Study completion20 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coccyx DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bayram Sönmez ÜNÜVAR, Principal investigator, KTO KARATAY UNIVERSTESI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917366
- Sponsor's protocol ID
- KaratayManipulation
- Status last verified
- Jun 2023
- First submitted
- 6 Jun 2023
- Last updated
- 23 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Manipulation in Combination With Exercise for Patients With Coccydynia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05917366
- Acronym / sponsor ID
- KaratayManipulation
- Conditions
- Coccyx Disorder, Pelvic Floor; Weak, Stretch
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 16 Jul 2022 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 23 Jun 2023 (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.
The aim of this study was to investigate the efficacy of manipulation combined with exercise as a treatment for patients with coccydynia.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coccyx Manipulation | Experimental | Other: Exercises, Other: Coccyx ManipulationManual therapy sessions, in addition to the exercise group, were performed once a week for four weeks. |
| Exercises | Active comparator | Other: ExercisesA total of 4 sessions were applied, 3 times a week. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- chronic (3 months) coccydynia
- age over 25 and under 60 years
- no ongoing antidepressant treatment
- no medicolegal litigation or occupational-accident etiology
Key exclusion criteria (2 listed)
- undergoing an operation aimed at the anal area
- those with additional diseases such as radiculopathy etc.
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 |
|---|---|---|
| ExercisesStretching exercise for the piriformis and iliopsoas muscles. strengthening exercises for pelvic floor muscles | Other | Coccyx Manipulation, Exercises |
| Coccyx ManipulationApplication of manipulation to relax the levetor ani muscle | Other | Coccyx Manipulation |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2023.
- Individual participant dataSharing planned: No
Related trials for Coccyx Disorder
RecruitingPhase 3
Study Evaluating the Analgesic Efficacy of Capsaicin 8% Patches in Chronic Coccygodynia.
Coccyx Disorder, Neuropathic Pain
Not yet recruiting
Effect of Pelvic Floor Muscles Down Training on Postpartum Coccydynia
Tailbone Disorders
RecruitingObservational study
Analgesic Efficacy of Capsaicin 8% Patch (QUTENZA®) in Coccygodygnia
Coccyx Disorder
Active, not recruiting
Ganglion Impar Block With Physical Therapy vs Caudal Epidural Steroid Injection With PT for Patients With Coccydynia
Coccyx Disorder
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.
Bayram Sönmez ÜNÜVAR principal investigator
KTO KARATAY UNIVERSTESI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercises and Coccyx Manipulation in people with Coccyx Disorder and Pelvic Floor; Weak, run by KTO Karatay 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 23 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2023.