Coccyx DisorderNCT05176431
Radial and Focused ESWT in the Treatment of Coccydynia According to Age and Body Mass Index
A study testing ESWT (wave type: focused) and ESWT (wave type: radial) in people with Coccyx Disorder, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
To date, focused and radial types of ESWT have been effectively used in the treatment of coccydynia. However, studies directly addressing a comparison between radial and focused types of ESWT in coccydynia have not been done. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Coccyx Disorder
- What is being tested?
- ESWT (wave type: focused) and ESWT (wave type: radial)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 25 Apr 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of coccydynia by clinical examination and X-ray imaging.
- be aged ≥18 at the time of diagnosis
- be give informed consent
Who cannot join
- Malignancy
- Those who have received ESWT treatment before
- Pediatric patients
- Patients with infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparation of Radial and Focused Extracorporeal Shock Wave Therapies According to Age and Body Mass Index in the Treatment of Coccydynia.
To date, focused and radial types of ESWT have been effectively used in the treatment of coccydynia. However, studies directly addressing a comparison between radial and focused types of ESWT in coccydynia have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused ESWT options on coccydynia.
- Conditions
- Coccyx Disorder
- Being tested
- ESWT (wave type: focused), ESWT (wave type: radial), ESWT (wave type: sham)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWT (wave type: focused)Device
Extracorporeal Shock Wave Therapy, device: Electronica, Pagani, Italy
ESWT (wave type: radial)Device
Extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
ESWT (wave type: sham)Device
Extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
| Study group | Role | What they receive |
|---|---|---|
| Focused extracorporeal shock wave therapy | Active comparator | Not described Receives: Device: ESWT (wave type: focused) |
| Radial extracorporeal shock wave therapy | Active comparator | Not described Receives: Device: ESWT (wave type: radial) |
| Sham extracorporeal shock wave therapy | Sham comparator | Not described Receives: Device: ESWT (wave type: sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
pain evaluation, higher scores mean a worse outcome.
Measured: 1 minute
Oswestry Disability Index
functional status of low back pain, higher scores mean a worse outcome.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start1 Feb 2022
- Primary completion1 Mar 2022
- Study completion25 Apr 2022
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, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Volkan Şah, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176431
- Sponsor's protocol ID
- University of Yuzuncu Yil
- Status last verified
- May 2022
- First submitted
- 30 Nov 2021
- Last updated
- 26 May 2022
- Results posted
- 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 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparation of Radial and Focused Extracorporeal Shock Wave Therapies According to Age and Body Mass Index in the Treatment of Coccydynia.
- ClinicalTrials.gov ID
- NCT05176431
- Acronym / sponsor ID
- University of Yuzuncu Yil
- Conditions
- Coccyx Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 4 Jan 2022 (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.
To date, focused and radial types of ESWT have been effectively used in the treatment of coccydynia. However, studies directly addressing a comparison between radial and focused types of ESWT in coccydynia have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused ESWT options on coccydynia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Focused extracorporeal shock wave therapy | Active comparator | Device: ESWT (wave type: focused) |
| Radial extracorporeal shock wave therapy | Active comparator | Device: ESWT (wave type: radial) |
| Sham extracorporeal shock wave therapy | Sham comparator | Device: ESWT (wave type: sham) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of coccydynia by clinical examination and X-ray imaging.
- be aged ≥18 at the time of diagnosis
- be give informed consent
Key exclusion criteria (4 listed)
- Malignancy
- Those who have received ESWT treatment before
- Pediatric patients
- Patients with infection.
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 |
|---|---|---|
| ESWT (wave type: focused)Extracorporeal Shock Wave Therapy, device: Electronica, Pagani, Italy | Device | Focused extracorporeal shock wave therapy |
| ESWT (wave type: radial)Extracorporeal shock wave therapy, device: Electronica, Pagani, Italy | Device | Radial extracorporeal shock wave therapy |
| ESWT (wave type: sham)Extracorporeal shock wave therapy, device: Electronica, Pagani, Italy | Device | Sham extracorporeal shock wave therapy |
Primary outcome
Visual Analogue Scale
Time frame: 1 minute
pain evaluation, higher scores mean a worse outcome.
Oswestry Disability Index
Time frame: 5 minutes
functional status of low back pain, higher scores mean a worse outcome.
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 26 May 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWT (wave type: focused) and ESWT (wave type: radial) in people with Coccyx Disorder, run by Yuzuncu Yil 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 3 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: finished, as of the sponsor's last update on 26 May 2022. 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. Some participants in this study may receive a placebo. 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?
Visual Analogue Scale (time frame: 1 minute). 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?
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 26 May 2022.