Coccyx DisorderNCT05142930
The Effect of Therapeutic Ultrasound on Pain in Coccydynia
A study testing Intermittent ultrasound and Continuous ultrasound in people with Coccyx Disorder, run by Cumhuriyet University at 1 site in Turkey (Türkiye).
Trial summary
Pain of the sacrococcygeal region is called coccydynia This painful clinical picture, which causes a decrease in the quality of life, also causes disability. Physical therapy modalities are used in the treatment of coccydynia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Coccyx Disorder
- What is being tested?
- Intermittent ultrasound and Continuous ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Jul 2022
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with coccydynia and having idiopathic or trauma history in etiology
- 18-75 years old
- The patient's acceptance of the ultrasound treatment to be applied
- Being in good mental health in terms of compliance with the treatment to be applied
- Receiving conservative treatment before ultrasound treatment
- The patient's numerical pain scale must be 5 and above
Who cannot join
- Being under the age of 18 and over the age of 75
- The patient's refusal to accept the treatment
- Wound or soft tissue infection in the skin area to be treated
- Pregnant patients
- Patients who have been diagnosed with malignancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Sivas Cumhuriyet University
Sivas, 58140
Emel Güler, MD, +905356492951, dremelguler@gmail.com
About this study
Pain of the sacrococcygeal region is called coccydynia This painful clinical picture, which causes a decrease in the quality of life, also causes disability. Physical therapy modalities are used in the treatment of coccydynia. Ultrasound, which is used for diagnostic and therapeutic purposes, can be applied in two ways as continuous and intermittent for therapeutic purposes.Our aim in this study is to compare the effectiveness of continuous and intermittent ultrasound in patients with a diagnosis of coccydynia and to examine its effect on pain.
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 coccydynia, the pain becomes continuous. Conservative treatment, interventional procedures and surgical treatment are used in treatment. Medical treatment, physical therapy and local injection applications are accepted as conservative treatment methods.Among the physical therapy modalities, ultrasound has been used for many years in diseases affecting the musculoskeletal system. Ultrasound, which is used for diagnostic and therapeutic purposes, can be applied in two ways as continuous and intermittent for therapeutic purposes.
A total of 52 patients who applied between 01/04/2021 and 01/04/2022 and met the inclusion and exclusion criteria will be included in the study. Continuous ultrasound will be performed in 26 patients and intermittent ultrasound will be performed in 26 patients. Randomization will be determined by the treatment protocol prepared in closed envelopes.Within the scope of the study, the age, height, weight, trauma history, duration of complaint, severity of pain and Oswestry Disability Index scale will be recorded before the interventions. The patients will be followed up at the 3rd week and 3rd month after the treatment. 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).
Data will be entered into 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 data showing normal distribution, and non-parametric tests will be used for data not showing normal distribution. 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 Disorder
- Being tested
- Intermittent ultrasound, Continuous ultrasound
- Keywords
- coccyx, pain, ultrasonic waves
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent ultrasoundOther
Intermittent ultrasound treatment will be applied to the muscles of the bilateral coccyx region
Continuous ultrasoundOther
Continuous ultrasound treatment will be applied to the muscles of the bilateral coccyx region
| Study group | Role | What they receive |
|---|---|---|
| Intermittent ultrasound | Active comparator | Patients with coccydynia will receive 10 sessions of physical therapy, 5 days a week for 2 weeks. Intermittent ultrasound will be used as a physical therapy agent. Intermittent ultrasound treatment will be applied to the muscles of the bilateral coccyx region at a dose of 1.0W/cm², at a frequency of 1 Megahertz, for 3+3 minutes. Receives: Other: Intermittent ultrasound |
| Continuous ultrasound | Active comparator | Patients with coccydynia will receive 10 sessions of physical therapy, 5 days a week for 2 weeks. Continuous ultrasound will be used as a physical therapy agent. Continuous ultrasound treatment will be applied to the muscles of the bilateral coccyx region at a dose of 1.0W/cm², at a frequency of 1 Megahertz, for 3+3 minutes. Receives: Other: Continuous ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Severity
Visual Analog scale (VAS) will be used to determine the pain severity of patients.
Measured: Change of VAS between baseline and at 3 weeks
Pain Severity
Visual Analog scale (VAS) will be used to determine the pain severity of patients.
Measured: Change of VAS between baseline and at 3 months
Disability
Disability assessment will be made using the Owstery Disability Index. The scale consists of 10 items in total. Each item is graded between 0-5. As the total score increases, the level of disability increases. The maximum score is 50 points. The total score obtained from the patient will be converted into the percentage system and the disability percentage will be calculated and evaluated.
Measured: Change of Owstery Disability Index between baseline and at 3 weeks
Disability
Disability assessment will be made using the Owstery Disability Index. The scale consists of 10 items in total. Each item is graded between 0-5. As the total score increases, the level of disability increases. The maximum score is 50 points. The total score obtained from the patient will be converted into the percentage system and the disability percentage will be calculated and evaluated.
Measured: Change of Owstery Disability Index between baseline and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start1 Apr 2021
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 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 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
- Model description
- Parallel groups will be received different treatment modalities
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
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
- NCT05142930
- Sponsor's protocol ID
- 2021-02/29
- Status last verified
- Dec 2021
- First submitted
- 16 Nov 2021
- Last updated
- 3 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haghighat S, Mashayekhi Asl M. Effects of Extracorporeal Shock Wave Therapy on Pain in Patients With Chronic Refractory Coccydynia: A Quasi-Experimental Study. Anesth Pain Med. 2016 Jun 1;6(4):e37428. doi: 10.5812/aapm.37428. eCollection 2016 Aug.
PubMed 27843777
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Ultrasound on Pain in Coccydynia
- ClinicalTrials.gov ID
- NCT05142930
- Acronym / sponsor ID
- 2021-02/29
- Conditions
- Coccyx Disorder
- Keywords
- coccyx, pain, ultrasonic waves
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cumhuriyet UniversityUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 3 Dec 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 coccydynia This painful clinical picture, which causes a decrease in the quality of life, also causes disability. Physical therapy modalities are used in the treatment of coccydynia. Ultrasound, which is used for diagnostic and therapeutic purposes, can be applied in two ways as continuous and intermittent for therapeutic purposes.Our aim in this study is to compare the effectiveness of continuous and intermittent ultrasound in patients with a diagnosis of coccydynia and to examine its effect on pain.
Detailed description
Coccygodynia often develops from an inappropriate sitting position or when standing up from a sitting position. In the advanced stages of coccydynia, the pain becomes continuous. Conservative treatment, interventional procedures and surgical treatment are used in treatment. Medical treatment, physical therapy and local injection applications are accepted as conservative treatment methods.Among the physical therapy modalities, ultrasound has been used for many years in diseases affecting the musculoskeletal system. Ultrasound, which is used for diagnostic and therapeutic purposes, can be applied in two ways as continuous and intermittent for therapeutic purposes.
A total of 52 patients who applied between 01/04/2021 and 01/04/2022 and met the inclusion and exclusion criteria will be included in the study. Continuous ultrasound will be performed in 26 patients and intermittent ultrasound will be performed in 26 patients. Randomization will be determined by the treatment protocol prepared in closed envelopes.Within the scope of the study, the age, height, weight, trauma history, duration of complaint, severity of pain and Oswestry Disability Index scale will be recorded before the interventions. The patients will be followed up at the 3rd week and 3rd month after the treatment. 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).
Data will be entered into 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 data showing normal distribution, and non-parametric tests will be used for data not showing normal distribution. 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel groups will be received different treatment modalities
| Arm | Type | Receives |
|---|---|---|
| Intermittent ultrasound | Active comparator | Other: Intermittent ultrasoundPatients with coccydynia will receive 10 sessions of physical therapy, 5 days a week for 2 weeks. Intermittent ultrasound will be used as a physical therapy agent. Intermittent ultrasound treatment will be applied to the muscles of the bilateral coccyx region at a dose of 1.0W/cm², at a frequency of 1 Megahertz, for 3+3 minutes. |
| Continuous ultrasound | Active comparator | Other: Continuous ultrasoundPatients with coccydynia will receive 10 sessions of physical therapy, 5 days a week for 2 weeks. Continuous ultrasound will be used as a physical therapy agent. Continuous ultrasound treatment will be applied to the muscles of the bilateral coccyx region at a dose of 1.0W/cm², at a frequency of 1 Megahertz, for 3+3 minutes. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with coccydynia and having idiopathic or trauma history in etiology
- 18-75 years old
- The patient's acceptance of the ultrasound treatment to be applied
- Being in good mental health in terms of compliance with the treatment to be applied
- Receiving conservative treatment before ultrasound treatment
Key exclusion criteria (5 listed)
- Being under the age of 18 and over the age of 75
- The patient's refusal to accept the treatment
- Wound or soft tissue infection in the skin area to be treated
- Pregnant patients
- Patients who have been diagnosed with 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 |
|---|---|---|
| Intermittent ultrasoundIntermittent ultrasound treatment will be applied to the muscles of the bilateral coccyx region | Other | Intermittent ultrasound |
| Continuous ultrasoundContinuous ultrasound treatment will be applied to the muscles of the bilateral coccyx region | Other | Continuous ultrasound |
Primary outcome
Pain Severity
Time frame: Change of VAS between baseline and at 3 weeks
Visual Analog scale (VAS) will be used to determine the pain severity of patients.
Pain Severity
Time frame: Change of VAS between baseline and at 3 months
Visual Analog scale (VAS) will be used to determine the pain severity of patients.
Disability
Time frame: Change of Owstery Disability Index between baseline and at 3 weeks
Disability assessment will be made using the Owstery Disability Index. The scale consists of 10 items in total. Each item is graded between 0-5. As the total score increases, the level of disability increases. The maximum score is 50 points. The total score obtained from the patient will be converted into the percentage system and the disability percentage will be calculated and evaluated.
Disability
Time frame: Change of Owstery Disability Index between baseline and at 3 months
Disability assessment will be made using the Owstery Disability Index. The scale consists of 10 items in total. Each item is graded between 0-5. As the total score increases, the level of disability increases. The maximum score is 50 points. The total score obtained from the patient will be converted into the percentage system and the disability percentage will be calculated and evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
- Background: PubMed 27843777Haghighat S, Mashayekhi Asl M. Effects of Extracorporeal Shock Wave Therapy on Pain in Patients With Chronic Refractory Coccydynia: A Quasi-Experimental Study. Anesth Pain Med. 2016 Jun 1;6(4):e37428. doi: 10.5812/aapm.37428. eCollection 2016 Aug.
- Effect of extracorporeal shock wave therapy on coccydyniaLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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?
A study testing Intermittent ultrasound and Continuous ultrasound in people with Coccyx Disorder, 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 6 inclusion and 5 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 3 Dec 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?
Pain Severity (time frame: Change of VAS between baseline and at 3 weeks). The study lists 4 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 NCT05142930, 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 3 Dec 2021.